Self Inspection

MASTER COPY
STANDARD OPERATING PROCEDURE For Restricted Circulation
LUCENT BIOTECH LIMITED {uNrr-u)

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
Department OUALITY ASSURANCE

Title Self Insoection
SOP No. Effective Date Review Date Suoersedes No. Revision No. Page No.
QA/o06-03 z\lo[l1;YY leloblwy+ QA/006-02 03 1of79
1.0 Objective
1.1 To lay down a procedure for carrying out self inspection of various department to
ensure the lmplementation and compliance with CGNIP to assess the area for
improvement and continuous Quality lmprovement
2.0 Scope
2.1 This SOP is applicable for carrying out the self- inspection of all functional
departmen! of Lucent Biotech Ltd. (Unit-ll) Roorkee.
3.0 Responsibility
3.1 The Audit Team shall be responsible for:

I g.r.r conducting the audit as per schebule.
3.1.2 Verification of the compliance of observations made in the previous audit.
3.1.3 Preparation of Audit Report
3-2 fhe QA personnel shall be responsible for

3.2.1 Preparation of annual calendar for audit.
3.2.2 Preparation of audit checklist for each department.
3.2.3 Compilation of audit and compliance reports.
3.2.4 Preparation of summary report ol audit findings at the end of Year.
3.3 The Head QA shall be responsible for:

3.3.1 Approval ofannual calendar for audit as well as approval oflist of auditors.
Authors Desiqnation Siqnature Date
Prepared Bv Officer QA Pl92 21 ob \nt-1-
Checked By Executive QA
^n\ ,a 9l ob a,.oL'2-
I tr'[tl
Approved By Head QA ,> o6l tn>L
Authorized Bv Head Plant 'y o6 ,oL'L
Formlt No. : QA,/oo1/Fo1-00
MASTLR COPY
STANDARD OPERATING PROCEDURE For Restricted Circ ulation
LUCENT BIOTECH LIMITED {uNrr-r)


Title Self lnsDection
SOP No. Effective Date Review Date Supersedes No. Revision No. Page No.
QA/o06-03 c3l obl >.>Y *)obllrtt QA/o06-02 03 2 ol79
3.3.2 Ensuring the conduction of audit as per schedule.
3.3.3 Review and approval of summary report of audit reports.
3.4 The Auditee shall be responsible for:

3.4.1 Preparation of corrective action along with time scale as specified in audit
repon.
3.4.2 lmplementing agreed corrective action recommended.
4.O Accountability
4-'l Head QA is accountable for implementation and compliance of oP.
5.0 Procedure:
I I
5.1 Areas for self-inspection but not limited to:
5.'1.1 Human Resources.
5.1.2 Storage of Raw materials, Packing materials, intermediates and finished

products.
5.1.3 Production and in process controls
5.1.4 Quality Control/QualityAssurance

5.1.5 Labels control. ;
t
5.1.6 Production related records.
5.1.7 Documentation.
Authors Desisnation -siqnature Date

Prepared Bv Officer QA W'v- .)l 7a LL
Checked Bv Executive QA D. /A ),
Approved By I Head QA ta/M., zz- I o5'l t-z tL
Yge"\-
Authorized Bv Head Plant z'Llo
Format No. : QAJ001/F01-00
MASTER COPY
STANDARD OPERATING PROCEDURE For Redtricted Circ ulation
LUCENT BIOTECH LIMITED tuHtr-ttt

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhan d)
Department QUALITY ASSURANCE

Title Self InsDection
QA/o06-03 >LlnL) r"L|_ i-L)o'l toL+ QA/o06-02 03 3 of 79
5.1.8 Deviation, Change control and Non conformance.
5.1.9 Batch Production records
5.1.10 Sanitation and hygiene.
5.1.1 1 Validation and revalidation programmes.
5.1.12 Calibration of instruments or measurement systems.
5.1.13 Complaints management.
5.1.14 Recall procedure.
5.1.15 Premises/plant facility including personnel facilities.
5.1.16 Maintenance of buildings and machineries.
5.1.17 Equipments.
5-1.18 Resu[s of previous self-inspections and any corrective to" ,"*.n.

5.2 Type of Self lnspection: Following type of self inspection shall be performed
5.2.1 Announced Inspection: This type inspection shall be conducted as per the
annual selt inspection schedule/ plan Announced Inspection should be
performed periodically (twice in year or Every six month tl5 days for each
department) for verification, monitoring, implementation and effectiveness of
quality systems by audit team selected by the Head of QA.
5.2.2 Un-Announced Inspection: This type of inspection Fhall be conducted on

need basis ie in case of any receipt of any critical market complaint, product
recall or observing any quality defects.

Prepared Bv Officer QA t h,}) ,-tloblr-.o}-L
Checked Bv Executive QA lllobl:-tL
Approved By Head QA 1-LlbLlr->L
Authorized Bv Head Plant :A--' tLz Io6l7-41'L
Formal No. : QAJ001iF01-001
LUCENT BIOTECH LIMITED (uNrr.r)

SOP No. Effective Oate Review Date Suoersedes No, Revision No. Page No.
QA/o06-03 +ll oLlvott .t'vl ob|1to>I- QA/006-02 03 4o179
5.3 QA head will be head of self-inspection team and heads of Q.C., production, stores,
personnel and maintenance or their authorized nominees shall be members of the
team. A list of the auditor shall be oreoared in format no. OAJ006/F03 titled "Lrst of
Auditors"
5.4 Evaluation of Auditors: The auditor shall be selected on the basis of following
poinl
5.4.1 Technical qualification: Technical qualification of auditor shall be science
graduate (minimum qualification B Sc / B. pharmacy / B.E. / B. Tech)
5.4.2 Experience: Minimum 5 years experience of pharmaceutical industries.

5.4.3 Training:
5.4.3.1 Auditor shall be taken training of SOP titled "Self inspection''
I u.o.a., l\4inimum three time audit shallfbe done as observer with auditor.
(This point shall not be applicable to department head).
5.5 Certificate shall be given to auditors as per format no. QAJ006/F14 titled "certificate
of Auditors"
5.6 Annual calendar for self-inspection shall be prepared and Approved for the
forthcoming year at the end of current Year (Refer format no QA,/006/F02 titled "Self
I inspection schedule"). t
5.7 Head QA shall announce the schedule and the team members for self inspection.
'Autbors Desiqnation sionature Date

Prepaied Bv Officer QA qAl-^Y'' zl oAI >6r-\-
Checked Bv Executive QA X,."):n 2r loAl t-bLL
I Approved By
Authorized Bv
Head QA
Head Plant
'"M-
;&.-:-
a,Lli6lr-1L_
06l tnLL
Format No. : deroOlifOt-OO
MASTER COPY
STANDARD OPERATING PROCEDURE I For Reslricted Circ ulation
LUCENT BIOTECH LIMITED ruNtr )

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (ljttarakhand)

Title Self Inspection
SOP No. Effective Date Review Date supersedes No. Revision No. Page No.
QA/o06-03 ttl oblrct-'t- c-'>)0fl,6t-f QA/o06-02 03 5 of 79
5.8 QA personnel shall be discuss with head QA, nominated auditor and auditee for
inspection date as given in approved self inspection schedule and circulate
inspection date in format No.QAJ006/F11 tiled "Self inspection circular"
5.9 Self inspection shall be conducted within t 15 days of the scheduled dates as per the
self inspection calendar.
5,10 Conduct the self inspection at least twice in a year lf possible increase the frequency
depending upon the complexities of operations involved. Carry out one inspection in
first half of the year and the second inspection in the second halt of the year. The gap
between the two insDections shall be minimum four months.
5.11 Self-inspe ion may also be contcted on special occasions for example before a
major aud Re-current market coinplaints or Re-current product failure / rejections
5.12 An auditor from QA department shall bepresentinall inspection.
5.13 Conduct the self inspection as per respective departmental audit check list. lf
additional shortcomings are observed, attach an annexure with the observations
5.14 Head of department or his nominee (Auditee) shall answer the queries of auditor
5.15 Auditors shall note down the lobservations and discuss the observations with
individual dept Head or auditee. The audit team shall also ensure that all previous
audit non conformances have been cleared up or addressed.
Authors Desionation Siqnature Date

PreDared Bv Officer QA (\S',\Z- Dbl \-zL
Checked Bv Executive QA 6Art1^ e,l loL,t val-2-
Approved By HeadQA fi#tr z>lobl*tl
Authorized Bv Head Plant "x I
>)- l D6l 1^LL
hormat No : QA,/001iF01-OO
STANDARD OPERATING P EDURE or Restricted Circ ulation

Title Self lnsoection
QA/o05-03 'r1)ob]ro)-z- 1-l-lobl ,.L+ QA/006-02 03 6 of 79
5.16 Based on the findings, Auditor shall make a report in the Format No. Q,aJ006/F10
titled "Self Inspection Audit Report" comprising of audit observation, recomrnendation
for improvement and action plan for the findings. The action plan (compliance for
audit observation) shall be given by Auditee and agreed action plan shall be recorded
in the format no. QA,/006/F13 titled "Compliance report of non-compliance raised
during self inspection".
5.17 The observations are classified as Critical, Major and minor based on the impact of
the observation on quality, safety, purity of the products and GMP. The general
guideline to be followed to classify is as given below:
5.'17.1 Critical: This directly affects the quality, safety and purity of product and not
complying Vith GIVIP practice. Corrective action to be taken inlTediately.
tf
5.17.1.1 Deflciencies which have a high probability of causing adverse
consequences to the patient.
5.17.'1.2 Consumer or may result in significant deviations in the safety, identity,

strength or purity of the product;
5.17.1 .3 Combination of major deficiencies which indicates a critical system
failure
tl
5.17.2u4ori This indirectly affects the quality, safety and purity of product and not
complying with GMP practice. Corrective action to be taken immediately
Authors , Desiqnation Siqnature , Date

Prepared Bv Officer QA ,Auy- ll o6l t-'L
Checked Bv Executive QA 4.ort)^ >1 oL I ,bL>
Approved By
Authorized Bv
Head QA
Head Plant
M-
")*-
o|l nLL
'oLIr--tL
Format No. ; QAJ001/F01-00
STANDARD OPERATING PROCEDU or Restricted CirGulation
LUCENT BIOTECH LIMITED (uNIr-rD
165/3, Nalhera, Anantplrr, Puhana, Roorkee, Distt: Haridwar (Uttarakhan d)

SOP No. Effective Date Review Date SuDersedes No. Revision No, Page No.
QA/006-03 11/oll 6ar t:t lo6lw-T QA/o06,02 03 7 of 79
5.17.2.1 Deficiencies which could potentially cause adverse conseq uences to

the patient.
5.'17.2.2 Consumer if left un-addressed could be considered indicative of poor
control.
5.17.2.3 A combination of minor deficiencies which indicate a major system
failure.
5.17.3 Minor: Defects, which can be noted and corrected at scheduled program. lf it
has no impact on the product quality but indicates departure with respect to
cGl\4P compliance.
5.18 Audit team shall be prepare report in format No. OA,/006i F13 titled "compliance
report of non-compliance raised during self inspection". within 7 working days and
senl a copy to respective department for action taken (corrective and preventive
action with targeted date).
I
5.19 Department head / designee shall be prepare compliance report and submit in QA
department within 7 working days after receive of observation report
5.20 Soft copy (electronically generated copy) can be use for preparation of the self
inspection report and compliance report.
5.21 Ouiity Assurance to check the adequacy of the actidn plan. lf some of the actions
are not appropriate or not sufficient then Quality Assurance to finalize the action plan
with consultation of concerned department head The self inspection report shall not
Authors Desiqnation Siq-oatu re )ate

Preoared Bv Officer QA M\!-'
.)4\^
L) oA ,<t'>L
Checked Bv Executive QA 1l lazL
Apfoved By Head QA a" \t'\lv zL lob 74>L
Authorized Bv Head Plant z.-l o6 1- LL
Format No : QAJoo1tso1-00
MASTER
STANDARD OPERATING PROCEDURE or Restricted Circ ulation
LUCENT BIOTECH LIMITED {uNrr- )

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uftarakhand)

SOP No. Effective Date Review Date Supersedes No. Revision No. Page No,
QA/006-03 ',-xloblroD- >Ll 6l L.1f QA/o06-02 03 8 of 79
be closed unless allthe non-comDliance has been eliminated and the same has been
verified by carrying out the follow up inspection
5.22 Department head / designee shall be complies all observation within targeted date as
mentioned in format No.QAJ006/F13 tiled "Compliance Report of Non-Compliance
Raised during Self Inspection".
5.23 In case of Critical observation, which require capital investment, inform management
for necessary corrective action and decide the target date of compliance
5.24 The CAPA shall be trigger as per SOP No QAJ035 titled "Procedure for Corrective
and Preventive Actions (CAPA)".
I
5.25 Department head / designee can be take 'extension for CAPA with proper justiflcation.
5.26 QA personnel shall be verified the closer status of CAPA and record in format No.
QAJo35/F01 titled "Corrective and Preventive Actions Form (CAPA) .
5.27 Time period for verification of the CAPA closure status by QA personnelwill bewithin
10 working days from targeted date
I s.za ntt CAPA shall be closed within 90 workifig days.

Head QA shall be verify compliance report after close of all taken CAPA and filled
self inspection closure report (Refer format No. OAJo06/F12).
Authors Desiqnation Siq{ature Date

'PreDared Bv Officer QA .W"\ry- 7,i'o|l t-t-z
Checked Bv
Approved By
Executive QA
Head QA
I nw-
$(l- n^ a)lobl r"'L2-
>zl t$l wzL
Authorized Bv Head Plant '>>loblwuL
FormatNo. : QAJo01/Fo1-00
MAS ER COPYI
STANDARD OPERATING PROCEDURE For Restricted CirculStion
LUCENT BIOTECH LIMITED tuNrr.u)

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (uftarakhan d)

SOP No. Effective Date Review Date Supersedes No, Revision No. Page No.
QA/006-03 :4lollvt-,t- 'LLloblr.)f QA/o06-02 03 9 of 79
6.0 Annexure
Sr.No. Annexure Title

Annexure-l Flow Chart for Self Inspection
2 Annexure-ll Self-lnspection Schedule
3 Annexure-lll List Of Self Inspection Auditors
Annexure-lV Audit Checklist of Warehouse department
5 Annexure-V Audit Checklist of Production
6 Annexure-Vl Audit Checklist of QC department
7 Annexure-Vll Audit Check List of QA Department
Audit Check List of Engineering & Maintenance

8 Annexure-Vlll
Dipartment
I
9 Annexure-lX Audit Check List of HR & Personnel Department
10 Annexure-X Self Inspection Audit Report
11. Annexure-Xl Self-lnspection Circular
12 Annexure-Xll Audit Closing Report
Compliance Report of Non-Compliance Raised During

Annexure-Xlll
Self-lnspection
14. Annexure-XlV Certiflcalion Of Performing Self inspection

'15. '
Annexure-XV Veriflcation for Completion of Action Taken (CAPA)
Authors Desiqnation Sionature Date'

PreDared Bv Officer QA u p\\)-2 >tl6LIr-)-L
Checked Bv Executive QA I ,rclr^ ztl 6 b L\4LL
Approved By I Head QA w4 . v2.lob\ ,aLL
>tt-
Authorized Bv Head Plant I 66 I L-o L2-
Format No. : QAJOOIiFOI-OO I

MASTEFT COPY
STANDARD OPERAT1NG PROCEDURE FOT REStTiCtEd CTCUIAI|ON
LUCENT BIOTECH LIMITED ruNrr-n)

'165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhan d)

SOP No. Effective Date Review Date Supersedes No. Revision No, Page No.
QA/o06-03 Lg)oLlroL'I- Lv) oil >otT QA/o06-02 03 1O of 79
7.0 History of Review

c.c.
Supersedes Reason For Review
Date C.C. No. Approval
no.
date
NIL NIL NL NIL New SOP
15t02t2019 QA,/o06-00 cct19t004 16tO2t2019 Periodic Review

> Check list are revised
for better control.
> New formats are
incorporated for better
15106t2020 QAJo06-01 cct20to15 16t06t2020 control
) Types of self
inspection are defined
for better control.
Edilorial Chanoes.
20t06t2022 QA,/o06-02 cct22t034 20t06t2022 > Periodic revised
8.0 References
Sr. No Reference Reference

Code
Current Good Manufacturing Practices (WHO cGN4P
cGMP
ouidelines)
2 SOP on SOP QAJOO'1
9.0 Abbreviations
SOP r i Standard Operating Procedure I

QA : Quality Assurance
QC : Quality Control
No. : Number
PreDared Bv Officer QA ilh^t -/ tt I
'd v"zz-
Checked Bv Executive QA tt.Irl z,t l ot l r-1'L
Approved By
Authorized Bv
Head QA
Head Plant
W ^
-j+y
z,i'l oal nz>
7t'l oAl wtL
Format No. : QA,/OO1/F01-Od
MASTEIi COPY
STANDARD OPERATING PROCEDURE I For Restricled Circ ulation
LUcENT BIOTECH LIMITED (uNrr-rD

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt Haridwar {Uttarakhand)
Deparlment QUALITY ASSURANCE

QA/o06-03 ,1lo[l w>> ,>>loblwL1 QA/o06-02 03 11 of 79
CAPA : Corrective and Preventive Actions

cGlVlP : Current Good Manufacturing Practices
HOD : Head of Department
10.0 DistributionList:
c
DeDUDistributed to Copy No.
No.
1. Head of department - Quality Assurance Master Copy
Office - Quality Assurance 1
Head of department - Quality Control

4. Head of deDartment - Production 3
t5. Head of department - Store r

4
6. Head of department - Engineering 5
7. Head of department - Personnel & Administration 6
, Authors Desiqnation Siqnature Date

Prepired Bv Officer QA \] r$).' 2l obl 1o2'L
'
Checked Bv
Approved By
Executive QA
Head QA
, W- v14\ 2llolrlwL\-
o6lto>L
Authorized Bv Head Plant ,'> obl vol L-
Format No : oPlool rol -oo
MASTER COPY
STANDARD OPERATING PROCEDURE T For Restricted Circ ulation
LUCENT BIOTECH LIMITED {uNrr-rl

QA/o06-03 tSlotlutt_ 1:LloLlwlr+ QA/o06-02 03 '12 ol 79
Annexure I
Flow Chart for Self lnsDection
Preparation and approval of the schedule
Formation of audit team
Conduction of the audit Self-inspection

checklist
Handling over of s?lf inspection

compliance repbrts to the
resoective DeDartment Heads
Corrective actions with Preventive actions with target

t^.^^l tl^fa date (lf any)
Authors Desiqnation Si-onature Date

PreDared Bv Officer QA
^
(tl 1"ll), ul bhl ,oL\
Checked Bv Executive QA llvt\ n^ 2-ll6 [, I 14 LL.
Approved By
Authorized Bv
HeadQA
Head Plant
W,
b-
>zl obl
Db
wtLl
I1.oLL
lFormat No. : QA,/001i FO1-00
MASTER COPY
STANDARD OPERATING PROCEDURE For RestrictedCirculation
LUCENT BIOTECH LIMITED (untr-nt

165/3, Nalhera, Anantpur, Puhana, Roo*ee, Distt Ha.idwar (Uttarakhan d)
Department QUALITY ASSUMNCE

SOP No. Effective Date Review Date SuDersedes No. Revision No. Page No.
QA/006-03 2-3) DLI't411' ,r->lDblbLL- QA/o06-02 03 13 of 79
Compliance Report given by

individual Departments
Submission of report to QA and

Allocation of audit Report
Numbers by QA
Target dates of Follow up (lf required) and Target dates of

Corrective closed out preventive actions
actrons (lf any)
Reporting to Head Ouality &

Top management
Format No.QA,/o06/F01-00
Authors ,Desiqnation Sianature ' Date

Prepared Bv Officer QA 0ilv\Y.- Lll obl t-ott-
^
Checked Bv
Approved By
Executive QA
Head QA
'M- J ,t-1-.
ob | .--a L'L
obl z.o rL-
Authorized Bv Head Plant oA | >oL2-
Format No. ; QAJ00'l/F01-00
MASTER COPY
LUCENT BIOTECH LIMITED (uNrr-rt)

'165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uftarakhand)

QA/o06-03 z\logly-ts- c:-l oblnt t QA/o06-02 03 14 ol 79
Annexur€-ll
LUCENT BIOTECH LIMITED ruNrr-l|
@ 165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhan dl
Title sel nsoection Schedule Paqe of
For Year:........,,............,....
Depar Month
tment
Jan. Feb. Mar. Apr. May. JUn. Jul. Aug sep. Oct, Dec.
Pan
Actual
Pan
Actual
Plan
Actual
Plan
Actual
Planl I
Plan
Actual
Prepared By Approved By
Format N o. QA,/p06/F 02 -01
Authors Desiqnation Sionature. Date

Prepared BV Officer QA WIY >l oLILnL2-
Checked Bv Executive QA LI obI LoLL
ApProved By Head QA W4- o{J rozl
Authorized Bv Head Plant *)- obl t4 t-L
Format No. : QAJ00'F01-00
MASTER COPY
LUCENT BIOTECH LIMITED (uHtr-tt)

'165/3, Nalhera, Anantpur, P!hana, Roorkee, Distt: Haridwar (Uttatakhan d)

QA/o06-03 a.3l obl t"'t-c.- 'L'Ll oblr44 QA/006-02 03 15 of 79
Annexure-lll
LUCENT BIOTECH LIMITED ruNr-n)
@ 165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (lJttarakl-rand)

Title List Of Self InsDection Auditorc Page_of_
Approved by
Sr. Total Head QA/
Name of Auditor Department Qualification
No, expeflence
Desiqnee
Format No.QAJOO6/F03-00
Authors Desiqnation Si-qnature Date

Preoared Bv Officer QA ' (ul,,r!Y- 2-l o[) tL
t.o
Checked Bv Executive QA.
^llrn' 2l oAl t-zL
Approved By Head QA t Iqil."r t-t-l o[l >o z t-
Authorized Bv Head Plant zz'l o6 I r,.oL2-
FormJt No. : QA"/001/F01-00
MASTER COPY
LUCENT BIOTECH LIMITED rururr-tn

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distl: Haridwar (Uttarakhan d)

QA/006-03 2-\loLl xz-'t- tL loLl n* QA/o06-02 03 16 of 79
Annexure-lV
LUCENT BIOTECH LIMITED rurr.rn
@ '165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)

Title AUDIT CHECKLIST FOR WAREHOUSE
MONTH/YEAR: SELF-INSPECTION No.
Section A: Selfinspection audit information

r. No. Particu lars Observations
1. Date(s) of Audit
2. Name of Auditee(s)
I
Name of Auditor(s)
4. Purpose of Audit Periodic AudiUSpecial audit for:
BRIEF REPORT
Documents reviewed
> SOPS r
Satisfactory/Not Satisfactory/N R
> Job responsibility Satisf actory/Not Satisfactory/N R
Record Reviewed
> Equipment Calibration Record ( lf applicable) Satisfactory/Not Satisfactory/N R
Authors Desionation Sio nature Date
PreDared Bv Officer QA U v)4' >) | ol, I t-Lr- '
Checked Bv Executive QA T turb ,t loh.l ,-LL
Approved By I Head QA lry4L .t>l o'61 >a>2-
Authorized Bv Head Plant oAlha
Format No : QA,/001/F01-00
MASTER COPY
STANDARD OPERATING PROCEDURE For Reitricted Circ ulation
LUCENT BIOTECH LIMITED rurrr-rn


QA/o06-03 '>1lo6l bLL L'>l o|ltoLt QA/006-02 03 17 of 79
> Equipment Qualification Record Satisfactory/Not Satisf actory/NR

> Process validation Record Satisf actory/Not Satisfactory/N R
> Equipment usage record (Sequel record) Satisfactory/Not Satisfactory/N R
> Employee training Record Satisfactoryi Not Satisfactory/N R
Facility Review
> Air Handling Uniulight Satisfactory/Not Satisfactory/NR
> Construction Satisfactory/Not Satisf actory/NR
> Painting Satisfactory/Not Satisf actory/NR
> Cleanliness And Pest Control Satisfactory/Not Satisf actory/N R
Knowledge and Practices of Employees
> Knowledge of employees Satisfactory/Not Satisfactory/N R
> Practices of employees Satisfactory/Not Satisf actory/N R
Results of previous lelf-inspections
I
> uorrectve steps l.laKen. Satisf actory/Not Sdtisfactory/N R
Conclusion:
nternal Qualitv Audit c

Sr. Compliance
Requirements Remarks
No. Yes No N/A
A. SOP
Are a complete index and a complete set of
1.
applicable SOBs available in the department?
I
2. Are the index and the SOP'S current?
3. Are the of SOP's available at the resoective olaces?
Check supporting documents and record in order to
Authors Desiqnation Sirrnature Date

Prepared Bv Officer QA Ah,\t]J- LIIo (l>o>L
Checked Bv Executive QA IX,-]^. >1 I oL I ]'aLL
Approved By Head QA lMu!?- >Ll 06l r€Ll_
Authorized Bv Head Plant 1z'loAl|^L2
Format No. : QAJ001/F01-0d
LUCENT BIOTECH LIMITED ruNrr-rrr


QA/o06-03 23lo6l>ot-'t, ,l loLlr4r+ QA/o06-02 03 18 of 79
verify the compliance of activity where ever

applicable.
Observation :
Compliance
Requirements
B. Personnel
Are their training records of the employees working
in the deoartment uo-to-date?
Have the employees undergone training in the
following areas?
. GMP
. SOP's
Are all employees following the garmenting SOP,
including, where necessary, masks, gloves, and
beard covers?
ls the job responsibilities of the personnel defined?
Obse
Compliance
Requirements
C. Receiving Bay:
ls the Air Curtain working properly?
ls the Area is clean as per SOP? Check Record.
ls the Area maintained in a good state of repair?
ls Vacuum Cleaner available?
Check it for proper functioning.
ls the SOP for operation and cleaning displayed?
ls the SOP for receipt & handling of materials I

displayed?
ls there an SOP describing the receipt of
components and the Examination to be done? ls the
examination documented?
Desiqnation
Officer QA vo)2-
Checked B Executive QA
Approved By
Authorized Head Plant
Format No. : dAJOOI /FO1-OO
MASTER COPY
STANDARD OPERATING PROCEDURE I For Restricted Cireulation
LUCENT BIOTECH LIMITED ruNrr-rl

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt Haridwar (Uttarakhan d)

QA/006-03 23)ogl+at:- zLl Db)\41+ QA/006-02 03 19 of 79
Where a shipment contains more than one batch, is

7. each batch tested and released separately?
Check Records.
In the event that containers are damaged, does the

SOP specify the corrective action to be taken? ls
8.
there documented evidence that the SOP is
followed?
Are containers of raw materials cleaned externally

9. on receipt? ls cleaning in accordance with a written
SOP?
10 Check the balances calibration records as per SOP.
Observation
Sr. Compliance
Reouirements Remarks
No. Yes No N/A
D.U der Test Area
1. ls the Area is clean as Der SOP? Chbck Record.
2. ls the Area maintained in a good state of repair?
Are materials stored batch wise i lot wise on
3.
separate pellets?
Check two or three products for proper under test
label.
Observation
Sr. Compliance
No. Yes No N/A
E. Sampling Area:
ls the Area is clean as per SOP? |
1.
Check Record.
Authors Desionation Si.qnature Date

PreDared Bv Officer QA I vIf9 abl voLl-
Checked By Executive QA >J DA l\-o L\
Approved By Head QA 'a- >r-l06 j lozl
Authorized Bv Head Plant Y' 6klr- -
I Format No :QAJOOl/FO1-OO
MASTER COPY
STANDARD OPERATING PROCEDURE For Reslricted CiTc ulation
LUCENT BIOTECH LIMITED ruHrr-ttt

'165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (uttatakhand)

Title Self Inspeclion
QA/o06-03 9.3)otDl ,42,> v>)oLlwl QA/o06-02 03 20 of 79
Examine the status board of the sampling room.

ls the material currently being sampled recorded on
it?
3 ls the airflow system operational?
ls the sampler appropriately gowned?
Are the containers that are to be sampled clean of
external dust and powder?
Select one of the raw materials currently under
quarantine.
ls the material recorded as havinq been sampled?
ls sampling equipments are stored in a manner to
5.
Drevent its contamination?
Check the given below records:
1. Validation status of RLAF
2. Validation status of Dynamic Pass box
6 3. Balance Calibration
4. Sampling Recorqs
5. Temperature & i ofArea I
6. Filter cleaning record
ls the current SOP for sampling of RM displayed and
7
followed?
Check two or three products for proper sampled
label.
Observation
Sr. Compliance
No Yes No N/A
F. Approved Areas:
ls the Area is clean al per SoP?
1.
Check Record.
Authors , Desiqnation Siqnature ' Date

Prepared Bv Officer QA Jtlr,-- 2l L4t2-2-
Checked Bv Executive QA ttOLn- zl OA ,4'L>
Approved By Head QA W- r4LL-
Authorized Bv Head Plant -a--: o6 La ?-L
Format No : QAJOOI/FO1-OO I
MASTEP.-coP
---.------
STANDARD OFERATING PROCEDURE For Restricted Circ ulation
LUCENT BIOTECH LIMITED ruNrr.u)

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (ljftarakhand)

QA/006-03 xl otly->- t->lohl\ALy QA/o06-02 03 21 of 79
Check the temperature & RH of the area wherever

3.
required.
Are different materials and different batches of the
same materialstored on separate pallets to prevent
mix-ups?
Check two or three products for proper labelling i.e.
5.
Approved Label.
Can materials be located easily within the stores
6
according to the assigned location?
Where appropriate, are allwork areas clearly
7. labelled with the name and the batch number of the
product being dispensed / sampled?
8 Are all items in the stores labelled as to their status?

ls PM stock rotated according to the FIFO rule?
9 ls RlVl stock rotated according to the FIFO / FEFO
rule? I I
Where the FIFO rule is deviated from? ls there
10
written iustification of the deviation?
ls access to the printed labels area restricted to
11.
authorized Dersonnel?
Are all printed labels stored in a restricted access
12.
atea?
Are packaging materials of different product,
13 strengths, dosage form, or quantity of contents
stored separately?
ls there an SOP for checking the accuracy of the
14.
balance used for dispensing of packaging material? I
Examine records of these checks
15.
. Are they performed according to the frequency
shown in the SOP?
. Where necessary, has appropriate corrective
Authors Desiqnation Siqnature, Date
Prepared B\ Officer QA (\4 !\ry-..- zl 't$l>">L
Checked Bv Executive QA , Lt obi LaLL
Apdroved By
Authorized Bv
Head QA
Head Plant
W
)L2- 2-'L
of I
I kl
t'ol-r
7,oLL
Format No. : QA,/oo1fF01-00
MASTETT COPY
STANDARD OPERATING PROCEDURE t For Restricted Circulation
LUCENT BIOTECH LIMITED (uNrr-nl

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwat (Uttarakhan d)

QA/006-03 Xslo[]pt-L LLlot)roLf QA/o06-02 03 22 ot 79
actionbeen imolemented?
ls there an SOP describing the dispensing of printed
16
oackaqinq materials?
ls there an SOP for dispensing additional packaging
17. materials if the quantity initially dispensed to
oroduction was not sufficient?
ls there an SOP for the return of printed packaging
materials to the stores?
18
. ls it followed?
. ls the return recorded?
Observation
Sr. Compliance
No. Yes No N/A
G.F nished Goods Store;
ls the Area is clean as per SOP?
1
Check Record.
2 ls the Area maintained in a good state of repair?
| ls there an SOP for the distribution of finish(S goods
3.
after release?
Examine the distribution records for products.
4
Are the goods distributed according to FIFO?
Observation :
Sr. Compliance
No. Yes No N/A
H.D spensrng
ls the Area is clean as per SOP?
1
Check Record
2 ls the Area maintained in a qood state of repair?
3 ls there an SOP describing dispensing opelations?
Examine the status board of the dispensing area
ls the material currently being dispensed recorded
on it?
ls the airflow svstem ooerational?
Authors Desionation Sionature Date
PreDared Bv Officer QA U uI{ z)l ol' >o2 L
hecked Bv Executive QA. >rlo
Approved By Head QA WL 2>1"$ >ot-L
A thorized Bv Head Plant ,tr-|06 L4rL-
Formal No. : QA"/OO1/FO1-OO
MASTER COIY
STANDARD OPERATING PROCEDURE For Restricted Circ rllation
LUCENT BIOTECH LIMITED (uNrr-rrl

'165/3, Nalhera, Anantpur, Puhana, Roorkee, Distl: Haridwar (Uttarakhand)

QA/006-03 xlnblw>t, 2-r)n6lLo L1- QA/006-02 03 23 ol 79
ls the person approoriatelv qowned?

Check the given below records:
. Validation status of RLAF
. Validation status of Dynamic Pass box
5
. Balance Calibration
. Dispensing Records
. Temperature & RH ofArea
. Filter cleaning record
. Cleanino of disoensino tools
ls the dispensed material stored as per proper status
6
label?
Observation
Sr. Compliance
No. Yes No N/A
l. Records & Traceability
Examine the record of the daily check of balances in
the department.
'I
. ls it comolete and accurdtelv filled out? I
. Are all results within the specifications?
1
. lf not, is there a record of the implementation of
corrective action?
. Perform a visual examination of the weights
used for the check
. Are they in a good state of repair?
. Check the calibration certificate of weiohts
Check the GRN File for proper filing.
2 Ask the person to show two or three month back
record and record the time?
Select two or three productq and verify the physical I
3.
stock?
ls the list of RM available with storaoe condition?
Authors Desiqnation Sianatu re Date

Prepared Bv Officer-QA utw- >l I o[l al>-
Checked Bv Executive QA luliL .'" >l / of, I ,r.o i-L
Approved By Head QA W:s- '>>l Jbl to."t
Authorized Bv Head Plant aLl okl rct-t-
Format No. : QA/001/F01-00
MASTER COF
STANDARD oPERA1ING PRoGEDURE For Rdstricted circ ulation
-
LUCENT BIOTECH LIMITED (untrrtt
'165/3, Nalhera, Anantpur, Puhana, Roorkee, Dist! Haridwar {Uttarakhand)

QA/006-03 23lohlvotz- >,Ll ol,h4LT QAio06-02 03 24 of 79
Any Other observation:
Sr. Name of the Auditor Signature Date

No.
Format No.QA,/o06/F04-01
Authors Desiqnation Siqnature , Date

PreDared Bv Officer QA w v\ty
Checked Bv Executive QA L$a^rl LI oAl'l^t-L
ApprovedBy
Authorized Bv
Head QA
Head Plant
W
,x-_-=
,2->l o'b
nL I1'4
) 14,r-L
Format No : QAJ001/F01-0b
MASii:i.i COPY
STANDARD OPERATING PROCEDURE I For Restricted Circulation
LUCENT BIOTECH LIMITED (uNrr-rD

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttatakhan d)

QA/o06.03 LLI o6l:,"z:. t4oLlyatl. QA/006-02 03 25 ol79
Annexure-V
ts
Department
LUCENT BIOTECH LIMITED rururr-rn
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhancl)
QUALITY ASSURANCE
Title AUDIT CHECKLIST FOR PRODUCTION Paqe No - of
MONTH/YEAR: SELFINSPECTION No.
Section A: Self-lnspection audit information

Sr. No Parliculars Observations
1. Date(s) of Audit
Name of Auditee(s)
Name of Audito(s)
I
4. Purpose of Audit Periodic AudiUSDecial audit for:
BRIEF REPORT
Documents reviewed
> SOPS Satisfactory/Not Satisfactory/NR
> Jpb responsibility Sa{sfactory/Not Satisfactory/NR
Record Reviewed
> Equipment Calibration Record ( lf applicable) Satisfactory/Not Satisfactory/NR
> Equipment Qualification Record Satisfactory/Not Satisfactory/NR
, Authors Desionation Siqnature Date
Preoared Bv Officer QA tMtF,..- 2l VXL
Checked Bv Executive QA 6 V'61-'\
t Approved By Head QA ' '.8${4, 9-'>- oEl wtL
Authorized Bv Head Plant nbl L0 12-
Format No. : bA,rootlFot-oo
llvtAs itir: copv
STANDARD OPERATING PROCEDURE For Restricted Circ ulation '
LUCENT BIOTEGH LIMITED turutr-tn

QA/006-03 )3f oLlrr,r >"lol)u">T QA/006-02 03 26 ol79
> Process Validation Record Satisfactory/Not SatisfactoryiNR

> Equipment usage record (Sequel record) Satisfactory/Not Satisfactory/NR
> Employee training Record Satisfactory/Not Satisfactory/NR
Facility Review
> Air Handling Univlight Satisfactory/Not Satisfactory/NR
> Construction Satisfactory/Not Satisfactory/NR
> Painting Satisfactory/Not Satisfactory/NR
> Cleanliness And Pest Control Satisfactory/Not Satisfactory/NR
> Knowledge of employees Satisfactory/Not Satisfactory/NR
> Practices of employees Satisfactory/Not Satisfactory/NR
Results of previous self-inspections
> Corrective steps taken. II SatisfactoryiNot Satisfactory/NR
Conclusion:
nrerna alitv Audit Chec

Compliance
No. Yes No N/A
A,SOP
't. Are a complete index and a complete set of
applicable SOPs available in the department?
2. Are the index and the SOP's current?

3. Are the of SOP's available at the respective places?
Check supporting documents and record in order to
I
Authors Desiqnation .
Siqnature Date
Prepared Bv officer QA (tllb!.,rx-- oLlroLL
Checked By Executive QA W".n\n 1tl6Ll r-LL
xeaorea
.
Approved By " Jdiru"t 1t-l ob >ozt

Authorized Bv Head Plant L>|oL t <|LL
Format No. : QAJOO1 /F01-00
MASTER COPY
STANDARD OPERATING PROCEDURE For Restrictdd Circ ulation
LUCENT BIOTECH LIMITED (uNrrr)

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Utlarakhand)

QA/006-03 D3lo 6luorr zL) 06lLor+ QA/006-02 03 27 ol 79
verify the compliance of activity where ever

aoolicable.
Observation
Sr. Compliance
No. Yes No N/A
B.Personnel
1.
applicable SOPS available in the department?
2 Are the index and the SOP'S current?
3. Are the of SOP's available at the respective places?
Observation
Sr. Compliance
Re q u ire rB ents RerYra rks
No. Yes No N/A
C. Fa ilities
1.
ls the department maintained in a good state of
eoai? | I
2.
ls the department heat and orderly with sufficient
soace for eouioment and operations?
3.
Are all the raw materials for one batch assembled on
a oallet?
Where more than one pallet is designated for one
batch, is each pallet clearlv labelled?
Are allwork areas cleady labelled with the name and
5.
the batch number of the Droduct beino orocessed?
Observation
Sr. Compliance
No. Yes No N/A
D. Prevention of Cross-Gontamination I
Are doors closed at all times?
1.
Do thev know ourDose of air lock?
2.
ls a personnel clothing clean, unstained, and dust
free. includino foot wares?
Authors , Desionation Siqnature ' Date
Preoared Bv Officer QA N"Y ,-llDAlioz)_
Checked Bv Executive QA l{.'rD?' >tl 6 6l \o,1-
Approved By ' Head QA Ng'"4 .rziob 14LL
Authorized Bv Head Plant L2- | olo 141'L-
Format No : QA,/OO1/FOl-OO t
MASI"ER COPY
LUCENT BIOTECH LIMITED rurrr-trt


QA/o06-03 Lll o$lpyr 7>)oblut l QA/006-02 03 28 oI 79
3.
ls pressure differential is maintained in working
areas at all times durino work?
A
ls there a record of the pressure differential?
5.
What is the quality of the air in the departmenl (filter
desionation)?
6.
Are their approved SOP'S for the maintenance of
filters?
7.
ls dirty equipment covered prior to transfer to the
washino room?
Obse vation
Sr. Compliance
No. Yes No N/A
E. Eq ipment and Facility Cleaning
1.
Are pallets and drums brought into the area clean
are free from oowder / dust / dirt?
2. ls the equipment neat, clean, and rust free?
3. Are the equipment suitably designed for its purpose?
Are fre equipment constructed so that product I
contact surfaces are not reactive or absorptive, so
that it will not contaminate or in any way affecl the
Droduct beino manufactured?
5.
Are there specific procedures for the cleaning of
maior eouioment items?
Do cleaning procedures include a requirement for
6.
the cleaning of accessories?
ls there a written procedure for washing the finger
7.
bags of fluid bed dryers?
Where compressed air is supplied to machinery, is it

8.
oil frde and flltered?
L ls there an SOP for riser filter replacement?
Authors Desionation iq natu Date

Prepared BV Officer QA W1r:4- r)lob \bL1-
Checked By Executive QA , \hq\,s rrll ob i.4'LL
Apbroved By Head QA
,-'MU .>'Llcbl WtL
Authorized Bv Head Plant 1't la6l rbi,'>-
Format No. : QtuOOl/FO1-OO
MAS]'i:il COPY
TANDARD OPERATING PROCEDURE I For Restricted Circ ulation


Title Self lnspection
QA/o06-03 13lo qLorl- t:
lo|l vr,t9] QA/o06-02 03 29 of 79
What filtration is provided to incoming air in fluid bed

10
dryers?
ls there an SOP for the cleaning and replacement of

11.
these fllters?
Observation
Sr. Compliance
No, Yes No N/A
F, Working Procedures
Examine the record of the daily check of balances in
1.
the department.
2 ls it complete and accurately filled out?
3 Are all results within the specifications?
lf not, is there a record of the implementationbf
corrective action?
Perform a visual examination of the weights with
5
which the check is performed. I
Are they in a good state of repair?
Do they bear a valid calibration sticker?
Examine the batch record for a batch that is being
processed.
6
Product:
Batch No.:
ls the master formula signed as being an accurate
7
copy of the original?
Have any changes to the master formula been
8.
authorized by QA?
ls the record completely and accurately fllted out up
I to the appropriate stage of processing?
'10. Are all in-process results within the deflned limits?
1'l Are the in process material properly labeled?

PreDared Bv Officer QA lLtuW >l I o6l >'yY
Checked Bv Executive QA Ytrt\^ zilohl >.zL
Approved By Head QA SdU.t .>zl6g1 6tL
Authorized Bv Head Plant
-'.|;-. o Ll t422-
Formlt No : QA,/OOl/FO1-OO
MAS-iii,{ coPY
STANDARD OPERATING PROCEOURE For Restricted Circ u'lation
LUCENT BIOTECH LIMITED (uNrr-rD


QA/o06-03 L3lobltoz> >1)ollvotF QA/006-02 03 30 of 79
ls there an SOP defining the holding period ofthat in

12
process material?
Examine a samole of in orocess material to be sent
13.
to the laboratory for testing
14. ls it labeled in accordance with the relevant SOP?
Do yield calculations conform to the standard yield
15.
given in BMR / BPR?
lf not, has a Bl\4R been completed and an
16
investigation conducted?
ls there a record of checking the sieve screens after
17.
use for signs of damage?
18
Are punches lubricated in the department and, if so,
with an approved lubricant?
19 ls there an approved SOP for in-process control?
Does the BMR/BPR state at what frequency tests
20
must be performed bv Production personnel?
Examine a batch record. t I
22. Do all test results conform to specifications?
Observation
Sr. Compliance
No. Yes No N/A
G. Lubricants
ls equipment designed in such a way that lubricants
1. or coolants cannot come into contact with
comoonents or druo oroduct?
Check whether food-grade ubricants have been
2.
used for lubricatino the eou omenl pans.
Examine the lubricants avalable in the department.
3. Are they clearly labelled and stored in a sanitary
manner?
Observation

Prepared Bv OfficerQA lL $4-"- l llob
Checked BV
Approved By
Executive QA
Head QA "W
w)h\ rllo6
,L1,lo Il \- ti-
Authorized Bv Head Plant ,)-2-lo
61 py2-
Format No. : QAi001/F01-00
MASI'Hi,I COPY
STANDARD OPERAfiNG PROCEDURE FOT REStTiCtEd CiTCUIAI|ON
LUCENT BIOTECH LIMITED (uNlrr)

165/3, Nalhera, Anantpur, Puhana, Roorkee, Disft: Haridwar (Uttarakhan d)

QA/o06-03 21l otlntt z:LloUntf QA/o06-02 03 3'1 of 79
Sr. Compliance
No. Yes No N/A
H. Equipment Calibration
ls there an approved annual program for the
1.
Calibration of all Droduction equioment?
Select three eouiDment items and examine the
2.
Calibration records.
ls all critical instrumentation on the eouioment items
3.
identified with a valid calibration tao?
Physically verify that all instruments found on the
eouiDment items are included in the Calibration file.
Are the Calibrations reports checked by appropriate
5.
Dersonnel?
6 Are the reports completely and accurately filled out?
Any Other Observation

No.
Format No.QA,/006/F05-01
Authors Desiqnation Siq nature Date

Prepared Bv Officer QA ittrrrrg al o$ '|4 2-L
Checked Bv Executive OA h,fi ra L] oL L4> L
Approved By Head QA
€]vt ,
LL sb ,o)L
Authorized Bv Head Plant ,fu.2' o6 ).2-1-
Format No. : QAJ00'I/F01-06
trrtRsrun copv
STANDARD OPERATING PROCEDURE ' For Restricted Circ ulation
LUCENT BIOTECH LIMITED ruNr-nl

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distl: Haridwar (l.Jttarakhand)

QA/006-03 aabb I nt-t, Dl.blt4L+ QA/o06-02 03 32 ot 79
Annexure-V I
LUCENT BIOTECH LIMITED ruHrrrn
@ '165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwaa (Uttarakhand)

Title AUDIT CHECKLIST FOR OUALITY CONTROL Paqe No- of
MONTH/YEART SELFJNSPECTION No.
Section A: SelfJnspection audit information

Sr. No Particulars Observations
1. Date(s) of Audit
2. Name ofAuditee(s)
3.f Name of Audito(s)

I
4. Purpose of Audit Periodic AudivsDecial audit for:
BRIEF REPORT
Documents reviewed
> SoPs/STPs/Specifications Satisfactory/Not Satisfactory/NR
t> Job responsibility I Satisfactory/Not Satisfactory/NR

Record Reviewed
> Instrument Calibration Record Satisfactory/Not SatisfactoryiNR
> Inslrument Qualification Record Satisfactory/Not Satisfactory/NR
Preriared Bv Officer QA vNrJ!- b6
Checked Bv Executive QA V.4r' ,1'1
ob
Approved By Head QA - Pfrfl.4 o6 ,aLL
Authorized Bv Head Plant -'\-) >zl 06 l>o'r L
Format No. fontoo rot -oo
MASI"LiI COPY
STANDARD OPERATING PROCEDURE ' For Restricted Circulation I
LUCENT BIOTECH LIMITED {uNr.n)


QA/006-03 z3lohlwLL 'L'Ll o 6ltoL+ QA/006-02 03 33 of 79
> Method validation Record Satisfactory/Not Satisfactory./N R

> Stability record Satisfactory/Not Satisfactory./N R
> Employee training Record Satisfactory/Not Satisf actory/N R
Facility Review
> Space and arrangement of laboratory Satisf actory/Not Satisfactory./N R
> Construction Satisfactory/Not Satisfactory/N R
> Painting Satisf actory/Not Satisfactory/N R
> Cleanliness And Pest Control Satisf actory/Not Satisfactory/N R
Knowledge And Practices of Employees

> Knowledge of employees Satisfactory/Not Satisfactory./N R
> Practices of employees Satisf actory/Not Satisfactory./N R

, Corrective steps taken -l Satisfactory/Not Satisfactory/NR
Conclusion:
Internal Qualitv Audi

Sr. Compliance
No, Yes No N/A
A. SOPs
Are the comolete index and a comolete set of
1.
applicable SOPs available in the dFpartmert?
2. Are the index & annexure current?
Are the of SOP's available at the respective
3.
places?
Authors Desiqnation qiqnature Date

PreDared Bv Officer QA iluy 2l)o[1N!)
Checked By
Approved By
Authorized Bv
Executive QA
Heab QA
Head Plant
"ru_
L-' ,a
)k-,-.--
ztlotlb>\
2,Ll6Al ro>I)
>vl4lt^t'u
I Format No. : QA/001/FOl 00
MASTER COPY
STANDARD OPERATING PROCEDURE For Restrictetl Circulation
LUCENT BIOTECH LIMITED ruHrr.rn

'165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt Haridwar (Utlarakhand)

QA/006-03 ),\loblt-tt- 14 o(.lrai-T QA/006.02 03 34 of 79
Check supporting documents and record in order

t4
to verify the compliance of activity where ever
applicable.
Observation
Sr. Compliance
No. Yes No N/A
B. Personnel
Are the training records of the employees working
1.
in the deDartment uo-to-date?
Have the employees undergone training as per
2.
SOP,GLP& Analytical techniques
Are detailed, written job descriptions available for all
3.
employees?
Observation
Sr. Compliance
No. Yes No N/A
C. Facilities
ls the laboratory maintained in a good state of
1.
repair?
ls the laboratory neat and orderly with sufficient
2.
space for equipment and operations"
3. ls the good housekeeping followed?
Are the laboratory instruments / equipments
qualified
Are all reagents and solutions
5.
. Clearly labelled with their proper name?
. Labelled with dale of receipt and/or expiration
date?
Authors , Desiqnation S'!qnature te

qI ol
Preoared Bv Officer QA UluW i>T
Checked Bv Executive QA /')- LI ohl to't-L
Approved By Head QA #HL4 L'L | 66l l41 x'
Authorized Bv Head Plant -E:- z> lobl t-o>L
Format No. ;OAJOOI/F01-00 |
MASTER COPY
STANDARD OPERATING PROCEDURE FOT REStTiCtCd CjTCUIAI|ON
LUCENT BIOTECH LIMITED (uNrr-r)

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (l.Jttarakhand)

QA/006-03 >3lob)r.att \->l o LlLo* QA/006-02 03 35 of 79
Are prepared solutions labelled with the

. Name of person who prepared them?
6.
. Date of preparation?
. Expiration date?
Observation
Sr. Compliance
No. Yes No N/A
D. lnstrumentation and Calibration
ls there an approved preventive maintenance
1. program for all equipment / instruments used in the
laboratory?
2 ls there evidence that it is followed?
ls the program based on manufacturel
3.
recommendations?
lf not, ts there a documented rationale for the I
alteration of the schedule?
ls there documented evidence that the person who
5. performs the pfeventive maintenance is qualified to
do so?
Are there written procedures for operating the
6.
instruments?
Are there wfitten procedures for calibrating the
7.
instruments?
8 ls there a valid calibration card on each instrument?
Examine the calibration records for the instruments.
I
. I
I Are they up-to-date?
. Are the results within limits?
Where standafds are used to calibrate an
10
instrument. is there a written Drocedure for their
PreDared BV Officer QA ln^'tt!-- ' r)-t oL 1,o)-'L
Checked Bv Executive QA .Ll oA \4)-L
ApProved By Head QA
,w"r 11I o6l,DL1^
Authorized Bv Head Plant :4.c-'-' ,r101 ,oL2-
Format No : QAJ001ryF01-00
MASTER COPY
LUCENT BIOTECH LIMITED {uNrr-rl

'165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)

QA/o06-03 '>alobl:,ltt '>11o6lr.Lf QA/006-02 03 36 of 79
preparation?
Where ever applicable are the inslruments are
11.
calibrated to the traceable standards?
ls there a schedule of validating the computer
12
software programme?
13 ls the schedule followed correctly?
Does the schedule includes all the relevant
14
software used in O.C.
Observation
Sr. Compliance
No. Yes No N/A
E. Sa 11ple Receipt, Storage and Documentation
ls a specific person responsible for the receipt of
1.
samples for testirig?
ls there a written SOP describing sample receipt
2.
and recordrng (loggrng In)? |
3. Where are samples stored before and after testing?
Are samples retained after completion of testing
and reporting? lf not, What happens to samples
after testing and repo(ing are complete?
ls there a time limit on how long a sample may
5.
remain in the laboratory prior to testing?
6. Afe the reserve samples kept as per procedure?
ls the aDDroved vendor list for all raw materials and
7.
packing materials available?
Observation
Sr, Compliance
No. Yes No N/A
F. Test Procedures
uthors
A Desionation Siqnature Date
Prepared Bv Officer QA 01h'9.- dbl )a)--'L
Checked By Executive QA DI ohl >n >L
Approved By Head QA Mu4, zt')obl tozz-
Authorized Bv Head Plant Cr'jjj z- oblt'ol'l-
Formlt No : QA,/001/F01-OO
MASTER COPY
LUCENT BIOTECH LIMITED ruNrr.r)

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakharrd)

SOP No. Effective Date Review Date SuDersedes No. ReYision No. Page No.
QA/006-03 9-LloQ :rct't- .L1'lobl1-oL+' QA/o06-02 03 3-7 of 79
Are there approved test procedures available for all

1.
tests performed in the laboratory?
ls there a written procedure for ensuring that all
2 pharmacopoeial procedures are updated when a
supplemental monograph is issued?
Examine the work currently being performed on the
HPLCS.
3.
Product Name :
Batch No. :
ls it being accurately followed?
Has the test method been validated for precision
5
and reliability?
Has the analyst recorded all the relevant details of
6. the product being tested, including the attachment
of printouts or record of weighing?
ls there documented evidenle that system
7. suitabilitv was determined Drior to use of the
I
chromatography in the analysis?
ls there a reference to the test method used in the
8.
analyst's Test Data Sheet (TDS)?
Do retention samples form part of laboratory
9.
recoros.
ls written cleaning procedure available for all
10
instruments and glassware?
Are laboratory records having name of Product and
11.
Batch number?
Are laboratory records indicbting date of receipt of
12
sample and expiry date?
Observation
Authors Desiqnation Sionature Date

Preoared Bv Officer OA (W\9- o[] 1az"t-
Checked Bv Executive QA )IaD.^ ob \,6a2
Approved By t Head QA W,&i- t2,l o bl vot2-
Authorized Bv Head Plant "a-.-.' >2- I ob li>t--
Format No. ; QA,/001/F01-00
MASTER COPY
STANDARD OPERATING PROCEDURE For Rd,stricted Circ ulation
LUCENT BIOTECH LIMITED (uNrr.[)


QA/o06-03 'L$l o 6l ,aL1- ?:L) o(.lr"Lr QA/006-02 03 38 of 79
Sr. Compliance
No. Yes No N/A
G. Recording Results
1 Examine an analyst's Test Data Sheet.
2. ls it neatly tllled in and legible?
3. Are any cross-outs initialed and dated?
ls there a record of the instrument used for testino
together with any raw data?
5. Are all calculations recorded?
Are all charts, graphs, and printouts labelled with
the
6.
. Product name and batch number?
. Date of the test?
Are numbers rounded in accordance with an
7.
approved SOP?
Do the date+n graphs/charts match with the dates I
8.
of analysis?
ls there a statement in the worksheet as to whether
9.
or not the samole oasses the test?
Are references of lnstruments/Eouioment's and
10
volumetric solution used oiven in the worksheet
Observation
Sr. Compliance
No. Yes No N/A
H. Reference Standards / Working Standards
1. Examine a rbference standard.
2 ls it stored appropriately?
3. ls document available for receipts of same?
Authors Desiqnation S.i-qnature Date

PreDared Bv Officer QA il, \JV)-
' -)t ob ) )42.L-
Checked Bv Executive QA I) .L1
ob I >o't L-
Approved By Head QA €sL4-- 2Ll oblr41r-
Authorized Bv Head Plant )l-+- L2- nilrozL-
Format No. : QA/001/F01-6
STANdARD OPERATING PROCEDURE For Restricted Circ ulation
LUCENT BIOTECH LIMITED lurr-tty


SOP No. Effective Date Review Date supersedes No. Revision No. Page No.
QA/006-03 13/06/urr- Lrl oh1t4L+ QA/o06-02 03 39 of 79
ls the standard tested internally to confirm its

4
quality?
ls there a written SOP for the preparation of
5.
working standards?
6. How often are working standards prepared?
7. What expiration date is given to working standards?
8 Has the expiration date been validated?
Are working standards certified against compendia
I standards?
ls there a record ofthe preparation of volumetric
10
solutions?
11. Are volumetric solutions freshly prepared?
12 lf stored, what expiration dates are given?
Examine a test where a volumetric solution was
13 used. Was the titre correctly recorded in the
notebook?
obsehation I
Sr. Compliance
No, Yes No N/A
t. oos
1. ls there an SOP for OOS handling
Does the responsibilities are clearly mentioned in
2.
the SOP for the handling of the OOS?
Check the log book for all recorded oos in
3.
between two self inspections
Check filled OOS with respect to current SOP. .
Observation
Sr. Compliance
No. Yes No N/A
. Authors Desiqnation Siqnature Date
Prep-ared Bv Officer QA $14 )l 06 \4>>
hecked By Executive OA ob I lo>2-
A proved By Head QA
"-\;
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'J'lD^
I >' 6t I
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Authorized Bv Head Plant '
Format No. :hA/o01/F01-00
MASTEiI COPY
LUCENT BIOTECH LIMITED ruHrr-rrr

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Utlarakharrd)

QA/o06-03 zsl bbl\4L:l- ," I DLI,,OLT QA/006-02 03 4() of 79
J. Evaluation of Results
ls there an SOP for review of test data and
1.
calculations?
Are raw data reviewed prior lo release from ihe
2. laboratory by a person other than the analyst who
performed the test?
Do reviewers sign the TDS to indicate that it has
3.
been reviewed?
Observation
Sr. Compliance
No. Yes No N/A
K. Methods Validation
1 Have all in-house methods been validated?
ls there a written SOP relating to the validation of
2.
analytical methods?
Check method validation for any pibduct which is
3 done in between two self inspections in respect to
SOP.
Observation
Microbiology Section
Sr. Compliance
No. Yes No N/A
L. Sample Receipt, Storage, and Documentation
ls a specific person responsible for the receipt of
1
e.mnlae f^r tActin^?
ls there a written SOP describing sample receipt
2
and recording (logging in)?
3. Where are samples stored before and after testing?
Authors Desiqnation sicnature Date

Prepared Bv Officer QA nLttuy' LI 06l!6)-2_
Checked Bv Executive QA tJE'.t 'DIo|l \41L
Approved By Head QA Wa,
'-4-E zz lo5l ta>'L
Authorized Bv Head Plant 'L>lobl Lo'L2'
r Format No. :QA/001/F01-00
MASTLfi COPY
LUCENT BIOTECH LIMITED rulr.rn

'165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt Haridwar (Uttarakhand)
Deparlment QUALIry ASSURANCE

SOP No. Effective Oate Review Date Supersedes No. Revision No. Page No.
QA/006-03 'L3l 06lra>2- >2-lo6l LoLr QA/o06-02 03 41 of 79
4. Are samples retained after completion of testing?

What happens to samples after testing and
5.
reoortinq are complete?
Examine the contents of a refrigerator and an
6.
incubator.
7. ls the equipment clean?
8.
Are alltest samples recorded in the laboratory
loqbook?
9. Are all items cleadV labelled?
Observation
Sr. Compliance
No. Yes No N/A
M. Test Procedures
Are there approved test procedures available for all
1.
tests Derformed in the laboratorv?
Examine the w rk culrently being performed.
Product Name r I
2.
Batch No.:
Test Procedure :
3. ls the test procedure at hand?
ls it up-to-date?
5. ls it being accurately followed?
Has the test method been validated for precision
6.
and reliability?
Are records available for the DreDaration of media
7.
used for performing the test?
8 ls the media labelleqwith an expiration date?
ls labeling done in accordance with an approved
9.
SOP?
10. ls the analysis recorded in the approved formats /
Authors . Desiqnation Sionature Date

Prepared Bv Officer QA L tD!- n|l t-r\,
Checked Bv Executive QA lr"'1, 2l oLItat'L-
Approved By Head QA AV
' >z-l obl w'rz-
Authorized Bv Head Plant t-2-l obl 1aLtt-
MASTIT{ {]OPY
LUCENT BIOTECH LIMITED rururr-rrr

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distti Haridwar (uftalakhan d)

QA/006-03 >'sl ablbtL, 1,2-)obl roLT QA/006-02 03 42 ot 79
protocols prior to beginning work?

ls there a written lvlicrobial monitoring programme
11.
for non-sterile products?
Observation
Sr. Compliance
No. Yes No N/A
N. Recording Results
1. ls it neatly filled in and legible?
2. Are any cross-outs initialed and dated?
3. Are all calculations recorded?
Observation
Sr. Compliance
No. Yes No N/A
O. Stock Cullures
ls there an SOP for the receipt and handling of
American Typed Culture Collection (ATCC) /
1.
National Collection of Typed Culture (NCTC)
cultures?
2. How often are ATCC / NCTC cultures transferred?
3. ldentification of master cultures.
Observation
Sr. Compliance
No. Yes No N/A
P. Evaluatioh of Results I
1. Are DATA routrnely reviewed by a supervisor?
Do reviewers sign the DATA to indicate that it has
2.
been reviewed?
Authors Desiqnation Si(rnature Date

PreDared Bi Officer QA c)hlrE4-l 1-ll Dbl voLL
Checked By Executive OA Wr,"t >,1 o Ll \aLL
ApProved By Head QA W+ L2-)obl >oLL
zL oL I 'to>L
Authorized Bv Head Plant -x.-,--
Format No : QA,/0011F01-00
'STANDARD OPERATING PROCEDURE I For Restricted Cireulation
LUCENT BIOTECH LIMITED (uNrr-[)

'165/3, Nalhera, Anantpur, Puhana, Roorkee, Disft: Haridwar (Uttarakhan d)

Title Self lnspection
SOP No. Effective Date Review Date SuDersedes No, Revision No. Page No.
QA/006-03 9-3l06l \ax-r, L1'lo 6l Lorf QA/o06-02 03 43 of 79
Observation
Sr. Compliance
No. Yes No N/A
Q. Environmental and Periodic Monitoring ( Clean Room )
ls there an SOP for monitoring differential air
L
oressures?
Are there written records of air oressures checked
2.
and sioned?
ls there an SOP for environmental monitoring in the
3.
clean room?
Do results conform with the limit stated in the SOP?
When out-o imit results were obtained, was
5. corrective action implemented in accordance with
the SOP?
Examine records of monitoring for the past three
6.
months. I
Check the trend charts of environment control
7. (settle plate exposure and air sampling) in
production areas.
Observation
Compliance
No. Yes No N/A
Are there updated schematic diagrams of location

't. plan of settle plate exposure and air sampling in
microbiology lab & production areas? |
Are the media stocks preoared in accordance to
2.
FIFO / FEFO rule?
3. ldentification of master cultures

Preoared Bv Officer QA utt tllo6 \4r2-
Checked Bv Executive QA ""1),^ zllol> \o>L
Approved By Head QA lfr)tY 2zlo6 LoaL
l.dl^{f-
Authorized Bv Head Plant ,4.4- Lz I 6bl vo 1-L-
Formbt No. : QA,/OO1/FO1-00
Irvrnwf,t Lo-pvl
STANDARD OPERATING PROCEDURE FOT REStTiCtEd CTC dIAtiON
LUCENT BIOTECH LIMITED tuNtrrtt


QA/o06-03 )3J o bl votr-- e-wlob)royf QA/o06-02 03 Mof 79
Any Other Observation :

No.
Format No. QAJ006/F06-01
Authors Desiqnation Sionatu re Date

PreDared Bv Officer'QA h JlY, Lt lob laLtL-
Checked Bv Executive QA trd o6 la2 L-
Approved By Head QA ',4.- n:-l f, 6l n>L
Authorized Bv Head Plant '-4*"' 06lLozL-
Format No. : OA,/OO1/FO1-OO I
MASTEI:i COPY
STANDARD OPERATING PROCEDURE For Rerstricted Circ ulation
LUCENT BIOTECH LIMITED ruHrr-rr)

QA/o06.03 2,Blob)w>r L1,l obl 1.oi_1, QA/o06-02 03 45 of 79
Annexure-V ll
LUCENT BIOTECH LIMITED tutttrrn
@ 165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (uttarakhan d)
Title AUDIT CHECKLIST FOR OUALITY ASSURANCE Paqe No- of
Section A; Self-lnsDection audit information

t. Date(s) of Audit
Name of Auditee(s)
Name of Auto(s) I
4. Purpose of Audit Pedodic Audivspecial audit for:
BRIEF REPORT
Documents reviewed
> SOPS Satisfactory/Not Satisfactory/NR
> Personnel I Satisfactory/Not Satidfactory/NR

Record Reviewed
> lnstrument Calibration Record Satisfactory/Not SatisfactoryiNR

Preoared Bv Officer QA UtV'- it lotl >ot-t--
Checked Bv Executive QA triA o tl oLl'ta'L2-
Approved'By Head QA sr,\ -' Lt-l Dbl raLtl-.
oL1-
Authorized Bv Head Plant 'M >z.l obl t
Format No : QA/001/F01-00
MASTEiI COPY
STANDARD OPERATING PROCEDURE For Restricted Cireulation
LUCENT BIOTECH LIMITED (uNrr-u)

Deparlment OUALITY ASSURANCE

QA/006-03 23loL lwzr. 7c-lo6lrot? 0A/006-02 03 4G ot 79
> Instrument Qualification Record Satisfactoryi Not Satisfactory/N R

> SOPS/STPS/Specifications Satisfactory/Not Satisfactory/NR
> BI\4R/BPR Satisfactory/Not Satisfactory/NR
> Job responsibility Satisfactory/Not Satisfactory/NR
> Employee training Record Satisfactory/Not Satisfactory/NR
> Practices of employees Satisfactory/Not Satisfactory/N R
> Corrective steps taken. Satisfactory/Not Satisfactory/NR
Conclusion:
n rna alitv Audit Check IS

Sr. compliance
No. Yes No N/A
A. SOP
1.
2. Are the index, SOP's and annexure current?
Are the of SOP's available at the respective
3.
places?
Check supporting documents and record in orden
to verify the compliance of activity where ever
applicable.
Observation
Authors Desiqnation Siqoature Date

Prepared Bv Officer QA v,. fY >t lob )aLL
\oL t-
Checked By Executive QA f',,):^ t-t) o[
I Approved By Head QA 1'Lloblhl'L
Authorized Bv Head Plant 'LL I ohl v,7:)
-4@.-
Format No :hryoollrot-oo
IMASIE,i COpvl
STANDARD OPERATING PROCEDURE For Restricted Circ ulation '
'
LUCENT BIOTECH LIMITED ruNrr.rr)

QA/o06-03 ZLInblTol\ >wlot)t-tf QA/o06-02 03 47 of 79
Sr. ComDliance
No. Yes No N/A
B. Pe sonnel
Are training records of the employees working in
1
the deDartment uD-to-date?
Have the employees undergone training in the
following areas?
2 . GMP
. SOP'S
. Qualitv Assurance Procedures
Question several employees about the operations
3. they are performing.
Are thev knowledqeable about their iob funchons?
4 including, where necessary, masks, gloves, and
beard covers?
ls an up-to-date organizational chart of the Quality
5.
Assurance Deoartment available? |
Observation
Sr. Compliance
No. Yes No N/A
C. Batch Record Review
ls there an SOP for batch record review prior to
1.
release?
ls there a comprehensive checklist for batch
2.
record review Drior to release?
Examine recently released batch records
3.
Product : Batch No:
Product : Batch Np. I
Product : Batch No.
Are the records complete with respect to the
following?
. The master formula is signed as true copy
Authors Desiqnation -Siqnature Date
PreDared Bv Officer QA t ,tv- >t I ob1 Lo12-
obl \'6L?
Checked Bv Executive QA ,t")',.t
Approved By ttead QA ru4- obl )aL2 t
Authorized Bv Head Plant ->.-z:a 1-2- obl 14&
lFormat No : QAJoO1/F01-OO
STANDARD OPERATING PROCEDURE For Restrictdd Cireulation
LUCENT BIOTECH LIMITED {uNrr.[)


QA/o06-03 L'tl o bl roL"L- zLl o6l w-t QA/o06-02 03 48 ol 79
. Any changes to the masier formula are QA

authorized prior to manufacturing
. All relevant signatures are present.
. All relevant data are present.
. All relevant data are accurate
. Yield calculation at each stage of production.
. All calculations are verified by a second
individual.
Observation
Sr. ComDliance
No. Yes No NIA
D. Chanqe Control Records
Are all changes that may impact product quality
1. authorized by Quality Assurance prior to
imolementation?
2. Examine recent chanqe control records
3 Have the forms beei comDleted and closed? I
Were any required tbsts performed and the results
4.
evaluated orior to closino the forms?
Have all relevant documentation been updated?
5. Verif,/ that validation protocols have been revised
where appropriate.
Observation
Sr. ComDlia ce
Requirements Yes No N/A
Remarks
No.
E. Self-lnspection
s there an SOP that self-inspection be performed
1.
n all departmentsA I
ls self-inspection performed according to the
2.
frequency stated in the SOP?
3 Do all personnel required by the SOP to participate
Authors . Desiqnation Siqnature te

PreDared Bv Ofiicer QA Urlut4 rt)ot II
Checked Bv Executive QA )o',t).q z,t I ott \41-L-
Approved By I Head QA
-Jry{,"l e,2-)oLl ra>L
,)-2, obl
Authorized Bv Head Plant -5'="' I roL'L
Format No. : QAJ001/F01-00 .
STEFI COPY
STANDARD OPERATING PROCEDURE rFor Restricted Circ ulation
LUCENT BIOTECH LIMITED ruNrr-r)

165/3, Nalhera, Anantpur, Puhana, Roorkee, Disn: Haridwar (Uttarakhand)

SOP No. Effective Date Review Date suDersedes No. Revision No. Page No.
QA/006-03 Lxl o6lLo:'r- 2rlD6lt4Ll QA/o06-02 03 49 of 79
in inspections actually do so?
Are written reports available for all inspections

performed during the year?
ls there written evidence of corrective action
5.
imolemented as a result of the insoections?
Observation
Sr. Complian ce
No. Yes No N/A
F. Complaints
ls there an SOP for dealing with complaints?
Examine recent complaints.
't. Product : Batch No
Product : Batch No
Product : Batch No
2. Do thl files contain allthe relevant data?
I
Have the files been signed by the relevant
3.
personnel?
Could any of the above complaints affect other

batches of the product and, if so, has an
investigation been initiated and appropriate action
taken?
Examine the list of complaints for the year
hrAâ.lin^ rhA .,
'.lit
5. Are there products that have several complaints
and, if so, has appropriale corrective action been I
implemented?
Observation
Authors Desiqnation Siqnature. Date

Prepared BV Officer QA all ob
Checked Bv Executive QA rA\ zl
1 )o$
ApProved By Head QA W+ \o'IL-
z2_l 06
Authorized Bv Head Plant "r\.')- zz- obl>o,
Format No : QAJoo'f/Fo1-00
MASTER COPY
STANDARD OPERATING PROCEDURE ' For Restricted Circulation
LUCENT BIOTEGH LIMITED rururr.rrr


QA/006-03 >x)6bl Lorl- nLl &lntl QA/006-02 03 5|o of 79
Compliance
No. Yes No N/A
G, Non-conforming Batches
Examine the list of non-conforming batches for the

current year Select three batches.
1. Product : Batch No.:
Product : Batch No:
Product : Batch No:
2. List the reason (s) for the reiection.
Specify at which stage of production the batches
3.
were reiected.
ls there a written investigation, including
conclusion as to the cause of the failure and, if
appropriate, follow-up action for each of the
batches?
Are there any products that have more than one
I- rejected batch and, if so, has corrective actlon

been recommended and imolemented? I
Observation
Sr. Compliance
No. Yes No N/A
H. Recalls
ls there a written procedure for the recall of drug
1 oroducts that ensures that resDonsible offlcials of
the firm are notified in wrilino of the recall?
Have there been any recalls during the current
2
yeat?
3. List the disposition of the recalled goods.
ls the disposition adequately justified wrth a
documented investigation and conclusions
authorized by Quality Assurance?
' Preoared Bv Officer QA A*Y-' blr )ot-t-
Checked Bv Executive QA - /"'l a^ 1-l ob \4L2-
Approved By Head QA "trilA- Lt o6
Authorized Bv Head Plant 2*4 2,> oh I 14L2-
Formal No : Qtu001/F01-00
MASI i!;; ',)i:lP
STANDARD OPERATING PROCEdURE For Restricted Circ ation
LUCENT BIOTECH LIMITED (uutrrD

'165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar {Uttarakhan d)
QA/o06-03 t\ )ob I wt-t- z+loLl wtf QA/006-02 03 51 of 79
Could the reason for the recall implicate other

batches of the product and, if so, has an
5.
investigation been initiated and appropriate action
taken?
Observation
Sr. Compliance
No. No N/A
l. Validation
ls there a written procedure for carrying out
't.
validation of drug products?
2. ls Master Validation Plan available?
3. ls it followed?
Check the validation file of any one of the products
being manufactured I I
Observation
Sr. Compliance
No. Yes No N/A
J. Others
Are there standard operating procedures for pest
't.
control?
2. ls it followed?
lS there standard operatinq procedure for
3.
qualifi cation and Validations?
Check whether it is followed.

Preoared Bv Officer QA u lrt-Y- 0 bl zoz-'t-
Checked Bv Executive QA ) Ll lob)r.L1-
Approved By I Head QA W,A- 'r2-l 06'l bL a-
,..2 'L2-l ob l rorL
'I Format' lo : OAJ001/F01-00
STER CO
STANDARD OPERANNG PROCEDURE For Restricted Circulation
LUCENT BIOTECH LIMITED ruNrrrl

165/3, Nalhera, Anantp!r, P!hana, Roorkee, Disft: Haridwar {Uttarakhar| d)

QA/o06-03 231oblvct> ,t1-l oblwtl QA/006-02 03 52 ol79
5. ls there standard operating procedure for training?

6. ls it adhered to?
7. ls the list of documents available?
Are alldocuments are arranged and maintained
8.
ProPerly?
Any Other Observation
Name of the Auditor Signature
Format No. OA,/006/F07-01
Authors Desiqnation Sianature t Date

Prepared Bv Officer QA IUNIY- tLl w'vL
Checked Bv Executive QA u4hn LI obl'yoZL-
Approved By Head QA 6& t-'t-l o6l Y62-
Authorized Bv Head Plant xJ D')bbltoLl-
Format No. : QA,/OO'l/FO1-Od
MAS'Ii]i"i COPY
STANdARD OPERATING PROCEDURE For Restricted Circulation
LUCENT BIOTECH LIMITED rururr-rn

'165/3, Nalhera, Anantpur, Puhana, Roorkee, Distl: Haidwar (ljttarakhan d)

QA/006-03 131 oLlL.L'L- >Ll o6l t QA/o06-02 03 53 of 79
"t1-
Annexure-Vlll
LUCENT BIOTECH LIMITED rurrr-rn

@ 165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhan d)

AUDIT CHECKLIST FOR ENGINEERING & Page No- _ of_
Title
MAINTENANCE
MONTH/YEAR; SELF]NSPECTION No.

1. Date(s) of Audit
Name of Auditee(s)
I
Name of Audito(s)
4. Purpose of Audit Periodic Audivspecial audit for:
BRIEF REPORT
Documents Reviewed
> s6ps
I Satisfactory/Not Satisfactory/NR
> Personnel Satisfactory/Not Satisfacto ry/NR
Data Reviewed
rAuthors Desionation Sionature Date

Preoired Bv Officer QA w:z- zl oL
L\l d"
7dLL
Checked Bv Executive QA ,o'I 7-
I Approved By Head QA .Ett. zL I oglwzL-
-,4.> -LZ o
6l ,oL7'
Format No :heloollrol-oo
MA SI'Eii COP
STANDARD OPERATING PROCEDURE t For Restricted Circ ulationr

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (lrttarakhand)

QA/006-03 ,>alobJ t aL1, >zl oal rot>f QA/o06-02 03 54 of 79
> Calibration Records Satisf actory/Not Satisf actory/N R

> Preventive Maintenance Records Satisfactoryi Not Satisfactory/N R
> Breakdown Maintenance Records Satisfactoryi Not Satisfactory/N R
> Alarms Procedures Satisfactory/Not Satisfactory/N R
> Receipt of New Equipment Satisf actory/Not Satisfactory/N R
> Filter Integrity Test Records Satisfactory/Not Satisfactory/NR
> Airflow Velocity Test Records Satisfactory/Not Satisfactory/N R
> Air Changes Test Records Satisfactory/Not Satisfactory/N R
> Maintenance of Tablet Punches and Dies Satisfactory/Not Satisf actory/N R
> Knowledge of employees Satisf actory/Not Satisfacto ry/N R
| I
:"""':;:T'JH:::';'J;'*'"^ Satisfactory/Not Satisfactory/NR
Conclusion:
rn Audrt Checklis
Sr. Compliance Remarks
Requirements
No. Yes No N/A
A. SOP
1. applicable SOPS available in the I
department?
2 Are the index and the SOP's current?

3 Are the of SOP's available at the respective
Authors Desiqnation Si-onature Date

PreDared Bv Officer QA NW D6 Itol?
Checked Bv Executive QA Uorx t)-l obl wLL
Approved By HeaE QA q&4- 'Lt, I or. I ntL
Authorized Bv Head Plant ,4-- ob I wl-L
I Format No :QA,/001/FO1-00
MASTEN COPY
STANDARD OPERATING PROCEDURE For ReslricteA Circulation
LUCENT BIOTECH LIMITED ruNrr-r)


QA/006-03 L3lbbl\oLL 2)loblbLf QA/006-02 03 55 of 79
places?
Check supporting documents and record in
order to verify the compliance of activity
where ever applicable.
Observation
Sr. Compliance
No. Yes No N/A
B. Personnel
1
the deDartment uD-to-date?
2 they are performing.
Are they knowledgeable about theirjob functions?
3 including, where necessary, masks, gloves, and
beard covers?
observation I I
Sr. Compliance
No. Yes No N/A
C. Ca bration Records
Are there written procedures, which describe
1
volurauvrI PrvucrJ r
2. ls there an aooroved annual calibration schedule?
ls there a tracking procedure in place to ensure
3 that every instrument included in the program
actually undergoes calibration on time?
ls the master list ofdnstruments and calibration I
4 procedures available in the area? Are they
maintained and updated?
5 How is new equipment entered into the calibration
Authors , Desiqnation Siqnature Date

Prepared Bv Officer QA u t\Lv- al ohi ;-r e-
Checked Bv Executive QA oa',.^ >t o6)).oLt
Approved By
Authorized Bv
Head QA
Head Plant
ffi4- 1
.LLJ oblra>?-
tL-Llotol\-LL
Format No. :QAJOO1/FO1-OO I ^, I
h/Asl'riri i,OPY
STANDARD dPERATING PRocEDURE or Restricted Circ ulation
LUcENT BIOTECH LIMITED (uNrr.r)

'165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar 1lJttarakhand)
Deparlment OUALITY ASSURANCE

QA/006-03 czlo L)t ott 2,Ll o 6l rdt-+ QA/o06-02 03 56 of 79
system?
6. Are traceable calibration standards emploved?
Are there certificates of calibration available for the
7.
standards?
ls there written evidence that the calibration
8.
standard used were within calibration?
Were the instruments calibrated according to the
9
freouencv indicated in the relevant SOP?
Are the calibration reports checked by appropriate
10.
personnel?
11. Are the forms completely and accurately filled in?
Were all the calibrations within the dellned limits of
12.
accutacy?
What procedure is followed if the results of the
13.
calibrations do not comply with the limits?
't4. How the external calibration contractor apDroved?
Observationl: I
Sr. ComDliance
No. Yes No N/A
D. Preventive Maintenance Records
ls ihere an approved annual preventive
'1.
maintenance program?
Are there written orocedures for preventive
2.
maintenance for all utility equipment?
3 Are there written records of performance?
Examine the preventive maintenance history of
equipments?
ls there written evidence for each machine that the
5 preventive marntenance was performed in
accordance with the relevant SOP?
6 ls the master list available which identifies that all
Preoared Bv Officer QA $ +ij!- 1 I c61^r.L2'
Checked By Executive QA Y64^ ) -l loAl F2L
ApFroved By Head QA "M^! L- '>'Ll obl 1-1 t-
Au horized Bv Head Plant a-'L I ob \b7 L
Format No. : QA,/ootFo1-oo

STANDARD OPERATING PROCEDURE T FOT REStTiCtEd CiTG UIAIiON
LUCENT BIOTECH LIMITED (urtrrD


QA/006-03 >31 o 6lr.ttt zzloLl >"t 9- QA/o06-02 03 57 ot 79
equipments are included?

Are the maintenance manuals, drawings, wiring
7 diagrams and parts list of equipments under
preventive maintenance program?
8. Are all documents properly signed and dated?
Observation
Sr. Compliance
Requirements N/A
Remarks
No. Yes No
E. Breakdown Maintenance Records
ls there a record of breakdown maintenance for
1.
each piece of production equipment?
Observation
Sr. ComDliance
No. Yes No N/A
F. Equ ipment Qualification
ls there an approved program for the qualFcation
1.
of eouipments?
2. Examine the lQ/OQ protocols.
Physically verify that all instruments found on the
3.
eouioment are included in the orotocols.
Cross-check with the calibration records that the
eouiDment items have the same classification the
qualification Drotocol as in the calibration report.
Are the qualification reports approved by all
5.
appropriate personnel?
Are the reports completely and accurately fllled
6.
out?
Observation I
Sr- Compliance
No. Yes No N/A
Authors Desiqnation I Siqnature Date

Prepared Bv Officer QA ww- trl o5/ lo'!r
Checked Bv Executive QA. .9),1^ n t I o6llnLL
Approved By Head QA
uv
rYV^l- LLI .blwz't
1,L16bl t-LL
'4-."-'
FormA No ; QA/001/F01-oo
MASI"Lll COPY
STANDARD OPERATING PROCEDURE For Restricted Circtlation
LUCENT BIOTECH LIMITED (uNrr.n)

QA/006-03
.)'tlo6ltot-v 1:Ll QA/006-02 03 58 of 79
"allaq-
G. Drawinqs
ls there a complete set of approved drawings for
't. systems and equipment available in the
department?
Check equipment items/systems and examine the
2.
available drawings.
3. Are the drawings the latest edition?
4. ls the drawing QA approved?
Observation
Sr. Compliance
No. Yes No N/A
H. Alarms Procedures
ls there a welldefined alarming system available?
1.
Specify the use
ls there an SOP for responding to alarms for
2.
critical systems? I I
3 ls there procedure followed?
Observation
Sr. Compliance
No. Yes No N/A
l. Filter Integrity Test Records
't. ls there an SOP for performing HEPA filter integrity

tests?
2. ls the procedure adhered to?
Examine records of the mpst recent tests
3.
penormeo.
ls it found in order?
Observation
Authors Desiqnation Si-onatu re Date

Prepared Bv Officei QA It $V- Ll 06lr-'t-L
Checked Bv Executive QA ,t'.'0, 2-l 06l t- LL
Approved By Head QA "ffiu. 1,1, dbll^ zz-
Authorized Bv Head Plant o b I r47,'L-

Format No : QA"/001/F01-00
MASTER COPY
STANDARD OPERATING PROCEDURE For Rdstricted Circ ulation
LUCENT BIOTECH LIMITED (uNrr-I)

165/3, Nalhera, Anantpur, Puhana, Roorkee, Dish: Haridwat (Uttarakhan d)
QA/006-03 L\l o 6l'tatt ,LLloLlr-L+ QA/006-02 03 59 of 79
Sr. Compliance
No. Yes No N/A
J. Airflow Velocity Test Records
1. ls there an SOP for performing the test?
2. ls the Drocedure adhered to?
Examine records of the most recent tests
3.
performed.
ls it found in order?
Observation
Sr. Compliance
No. Yes No N/A
K. Air Changes Test Records
1. ls there an qOP for performing the test? I
2. ls the procedure adhered to?
Examine records of the most recent tests
3
performed.
Observation
Sr. Compliance
No. Yes No N/A
L. Walk-Through of System
Perform a walk-through inspection of the entire
1.
system. I t
ls the general environment clean and tidy for
2. . Potable water storage?
. The purified water production system?
Authors Desiqnation Sisnature , Date

Prepared Bv Officer QA luw- 71 bbtr,olL
Checked Bv Executive QA 21Jol,l1a2L
Approved By Head QA MM ZLlc,bl\a1,2-
Authorized Bv Head Plant ,4-t 2Z Dbl 1,a>2-
Format No. : QA"/001/F01-0b

LUCENT BIOTECH LIMITED rurrr-rrt

QA/o06-03 csloat-t: t\ o6lnzq- QA/006-02 03 60 ot 79
. The purifled water storage system?

ls the system leak free, rust free, and well
3.
maintained?
Are system controls such as electrical panels and
switches protected so as to prevent accidental
tampering?
5.
ls access to the main water holding tank for the
factory restricted?
6.
Are the covers to the main water holding tank
Iocked?
7.
When was the main water holding tank last
cleaned / sanitized?
ls this recorded and is it in accordance with the
8.
relevant SOP?
When the purifled water production system was
I
last sanitized?
10.1 Was it in conformance with the relevant SOP? |
Are user points well maintained, with flexible
't1.tubing stored in such a way as to minimize
contamination?
Observation
Sr. Compliance
No. Yes No N/A
M. System Drawings
ls a complete set of up-to-date system drawings
1.
available to I
. The system operator?
. l\,4aintenancepersonnel?
2. Compare the drawings with those in the most
i Authors Desionation , Siqnature Date
Prep'ared Bv Officer QA wvr- >ll bbl r.42L
Checked By Executive QA ont' ,e" LtIDbI1412-
1 |tL,ll
Approved By Head QA Nttlw4 'L>l o bl)aL2-
Authorized Bv Head Plant -X-4-; 1-Ll obl rnt-z-
Format No :lQgootlrol-oo
MASTER COPY
STANDARD OPERATING PROCEDURE For Restricted Circulation I
LUCENT BIOTECH LIMITED ruNrr-[)


QA/006-03 z}logl6f- L'LlDbl)41+ QA/o06-02 03 61 of 79
recent validation file. Are they the same?

3 Have any changes been authorized by Quality
Assurance?
Has a change control form been completed?
5 Did the results meet the specifications?
Observation
Sr. Compliance
No. Yes No N/A
N. System Operating Records
1. Examine the daily checklists for the water system

for two months precedinq the audit.
2. Have they been completed on a daily basis?
lf any faults or breakdowns in the system were
3 noted, was an unusual event. Report form
completed and distributed to conclrned
oersonnetl
I
Observation
Sr. Compliance
No. Yes No N/A
O. Svstem Maintenance Records
Examine records of performance of preventive
maintenance.
Do they include the following?
. Cleaning and sanitation of the main water
1. holdingtank I
. Cleaning and sanitation of the purified water
production system
Cleaning and sanitation of the purified water
storage system

Preoared Bv Officer QA ru]t'- al 0bIt'oL2,
Checked Bv Executive QA vr)' n^ L) )n, L-
Db l
Approved By
Authorized Bv
Head Ql
Head Plant
W-
,)<,*-
Dbl LoL2-
oblwzL
I Format No : QA"/OOI/FO1-OO
STANDARD OPERATING PROCEDURE For Restricted Cireulation
LUCENT BIOTECH LIMITED ruNrr-[]


Self Insoection
SOP No. Review Date Suoersedes No. Revision No, Page No.
wslo bl vot-t- v'loaluW QA/o06-02 62 ot 79
Observation
sr. Compliance
No. Yes No N/A
P. System Monitoring Records
1.
ls the system sampled according to the frequency
stated in the SOP?
2 ls sampling performed at all locations stated in the
soP?
3. Do results conform to the limits stated in the SOP?
When out-of-limit results were obtained, was
4 corrective action implemented in accordance with
the SOP?
What is the overall oicture of the state of control of
5.
the ourified water svstem?
Observation: I I
Sr. Compliance
No. Yes No N/A
Q. System Validation File
Examine the validation file for the purified water
1.
system
2.
Was the validation perforrned according to
schedule?
Does the report indicate that the system is
3.
operating in a repeatable and reliable manner?
Observation:
Water System
Authors Desiqnation Siq natu re ' Dete

Preoared Bv Officer QA tfuuw-- Yl ob Jfo>'t-
Checked Bv Executive QA X,,r,\,n \rl o6l w>t
Approved By Head QA 'W"t ' LzJ o[ | r..rL
Authorized Bv Head Plant Db I I4LL
MASTEi:.] COPY
STANDARD OPERATING PROCEDURE t For Restricted Circ ulaiion
LUCENT BIOTECH LIMITED (uNrr.[)

Department QUALIry ASSURANCE

QA/006-03 >al oblwt:t- >t lobltozi- QA/o06-02 03 63 of 79
Sr. Compliance
No. Yes No N/A
A. Walk-Through of System
Perform a walk-through inspection of the entire
1.
system.
ls the general environment clean and tidy for
2 Potable water storage?
. The purified water production system?
. The purified water storaoe svstem?
ls the system leak free, rust free, and well
3
maintained?
Are system controls such as electrical panels and
switches Drotected so as to Drevent accidental
tampering?
5
ls access to the main water holding tank for the
fact+y restricted? I
6 Are the covers to the main water holding tank
locked?
7.
When was the main water holding tank last .
cleaned / sanitized?
ls this recorded and is it in accordance with the
8.
relevant SOP?
When the purifled water production system was
9
last sanitized?
10 Was it in conformance with the relevant SOP?
Are us r ooints well maintained. with flexible
11. ...t
tuorng toreo In sucn a way as to mrnrmrze
I
contamination?
Observation:
Authors, Desiqnation Sionature Date

Prepared Bv Officer QA \ntY z)lD6l ,o2 l-
Checked Bv Executive QA ldoq),"- Lt lobl )a>L
Adproved By Head QA
t'ffii-,a-, >LloLltott
Authorized Bv Head Plant /3)' 2L ) obl i.E1)-
Format No. : OA/0d1/F01-00
MASTER COPY
STANDARD oPERATING PRocEDURE For Restricted Circ ulaiion
LUCENT BIOTECH LIMITED ruHrr.rrr

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (lJttarakhan cl)
Depafiment QUALITY ASSURANCE

QA/o06-03 :3l o6lw>2, >LloL l1.oLf QA/006-02 03 64 ot 79
Sr. Compliance
No. Yes No N/A
B. System Drawing
ls a complete set of up-to-date system drawings
1.
available to
Tha cvctam
^Âr.t^r?
Maintenance personnel?
Compare the drawings with those in the most
2.
recent validation file. Are they the same?
Have any changes been authorized by Quality
3
Assu rance?
4 Has a change control form been completed?
5 Did the results meet the specifications?
Observation:
Sr. Compliance
No. Yes No N/A
C. System Operating Records
Examine the daily checklists for the water system
1.
for two months preceding the audit.
2 Have they been completed on a daily basis?
lf any faults or breakdowns in the system were
noted, was an unusual event Report form
3
completed and distributed to concerned
personnel?
Observation:
Sr. Compliance
No. Yes No N/A

Prepared Bv Officer QA (l)t p\1-' >t obl ro't-
Checked Bv Executive QA obj taL:L
Approved By Head QA 2Ll triol Lo1-2-
.A-A \L I obl 14LL
Formf,t t'to : QAJool /Fo1-oo
MAS-Ii-:ti COPY
STANDARD oPERATING PRocEdURE For Restricled Circdlation
LUCENT BIOTECH LIMITED ruNrr-I)


,r-\l
QA/o06-03 oLltd-L >1406lL.Lr 0A/006-02 03 I 65 of 79
D, System Maintenance Records
Examine records of performance of preventive
maintenance.
Do they include the following?
. Cleaning and sanitation of the main water
1. holding tank
. Cleaning and sanitation ofthe purified water
production system
Cleaning and sanitation of the purified water
storage system
Observation:
Compliance
No. No N/A
E. System Monitoring Records
ls the system sampled according to t're frequency
1.
stated i; the soP? | I
ls sampling performed at all locations stated in the
2.
SOP?
3. Do results conform to the limits stated in the SOP?
When oufof-limit results were obtained, was
corrective action implemented in accordance with
the SOP?
5.
What is the overall picture of the state of control of
the purified water system?
Observation :
Sr. t Compliance I
No. No I N/A

PreDared Bv Officer QA u sva'--/
Checked Bv Executive QA ob 14?-
Approved By r Head QA "&L4 d$ ,.tt-
Authorized Bv Head Plant "2.:) I b|l r.6LL
Format No. : QAJ001/F01-00
MASTE i.{ coPY
STANDARD OPERATING PROCEDURE For Re'stricted Cirq ulaiion
LUCENT BIOTECH LIMITED ruNrr-rn

'165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)

QA/006-03 zUoblraL t\ oblwft QA/006-02 03 66 of 79
F. System Validation File

Examine the validation file for the purified water
1.
system
2 Was the validation peformed according to
schedule?
Does the report indicate that the system is
3
operating in a repeatable and reliable manner?
Have any non conformity's with the validation
protocol been indicated in the report, explained,
and suitablv authorized?
Sr. ame of the Auditor Signature Date

No. I
Format No QAJ006/F08-01
Authors Desiqnation Siqnature '

Date
PreDared Bv Officer QA LA!V'.' 1-J10b La12-
Checked Bv Executive QA Vv"l^" i-l ol' Vo1'L
ApprovedBy Head QA '&/ia- L2-)ob)t--'rz
Authorized Bv Head Plant :) yzloblwt-L-
Format No : Qtu001/F01-0b
IMASI-11'J'.-@

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Utlarakhan d)

QA/o06-03 23lo 6l toLl- 2,t lot lNtf QA/o06-02 03 67 ol 79
Annexu re-lX
LUCENT BIOTECH LIMITED rurrr-rt

@ '165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakharrd)

Title Audit Checklist for HR & Personnel Page No. _ of_
BRIEF REPORT

1. Date(s) of Audit
2. Name of Auditee(s)
3. Name of Audito(s)
4. Purpose of Audit Periodic AudiVSpecial audit for:
Documents reviewed
) SOPs Satisfactorv/Not Satisfactorv/N R
> J6b responsibility SatiEfactory/Not Satisfactory/N R
Record Reviewed
> Equipment operation Record ( lf applicable) Satisfactory/Not Satisfactory/NR
,Authors Desiqnation ,Sionature Date

PreDired Bv Officer QA Wn! )t)t of,l y.1-L
Checked Bv Executive QA u'4b >l )obl taLL
I Approved By Head QA
| ' +941
c4tn44 |t-l 06l roLz--
Authorized Bv Head Plant fu-l LLI +l bLL
Format No. : beloot/rot -oo
MASTF.II COPY
STANDARD OPERATING PROCEDURE For Restricted Cireulation'

Depariment QUALITY ASSURANCE

QA/o06-03 >slE bl ,cL"L ,4 oblt-d)-+ QA/o06-02 03 68 of 79
> Cleaning Record Satisfactory/Not Satisfactory/N R

> Medical Record Satisfactory/Not Satisfactory/N R
> Employee training Record Satisfactory/Not Satisfactory/N R
Facility Review
> Construction Satisfactory/Not Satisf actoryi N R
> Painting Satisfactory/Not Salisfactory/N R
> Cleanliness Satisfactory/Not Satisfactory/N R
> Corrective steps taken. Satisfactory/Not Satisfactory/N R
Conclusion:
I
A klist
Sr. Compliance
No. Yes No N/A
A. SOP
Are a comolete index and a comDlete set of
1
2. Are the index, SOP's & annexure current?
the of SOP s available at thetrespective
3. ,Are I
praces /
Check supporting documents and record in order
4. to verify the compliance of activity where ever
applicable.
Prepared Bv Officer QA thty-) 2l
Checked Bv Executive QA l,lrr4t,o- Dllo I wtz:
Approved By IAAU ,>1,1 Dbl
Hedd QA ,Xuli14 vnLL
Authorized Bv Head Plant A"-J D bl l.o'
--
I Format No :QAJ001/F01-00
STANDARD OPERATING PROC For Restricte'd Circ ulation
LUCENT BIOTECH LIMITED rurrrn

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (uttarakhan d)

QA/o06-03 2,7)bblL"L1, z:t)otltntl QA/006-02 03 69 of 79
Observation
Sr. Compliance
No. Yes No N/A
B. Personnel
1.
the deoartment uo-to-date?
2. they are performing.
Are they knowledgeable about their job functions?
ls an up-to-date organizational chart of the
3
Personnel Department available?
Observation
Sr. Compl ance
Requirements Re marks
No. Yes No N/A
C. Pest Control
1. ls there an SOP for Cest Control Procedures? I
2 ls it followed?
Are all the procedures clearly given for control of
3. all types of pests and their ffequency of control
followed?
4 Examine recent Pest Control records
l\ilaterial Safety Data sheet (MSDS) for each
5.
chemical used available?
Are the records complete with respect to the
followino?
-l t
. All relevant signatures are present
6.
. All relevant data are present.
. All relevant data are accurate.
. Are all the records pfoperly verified by pest
Authors Pesignation
_onicer Sionature ' Date
PreDared Bv oa Wla-' 2,1| ob
2ll
thr-L-
Checked Bv Executive QA Dr1)^ D[r '142-L-
Approved By Head QA "W4 LL-l o 6l tot-t-
Authorized Bv Head Plant t .) aLlo i w*-
Format No : QAJoO'I/FO 1-00 I
For Restricted Circulation
LUCENT BIOTECH LIMITED runrr-rn

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (l.Jftarakhan d)

QA/o06-03 ul oLlt zt- 121 obl LaLt QA/o06-02 03 70 ot 79
controlAgency?
. ls pest control agreement available?
Observation
Sr. Compliance
Requirements Re marks
No. Yes No N/A
D. Medical Checkup
Are all new employees medically checked before
1
employment and certified fit?
Are all employees medically examined at least
2
once in a year?
Are details of major illness of all employee
3
available?
Are there written procedures for Medical Checkup
of Employees?
5 Examine allthe employees Medical Reports.
observatitn I
Sr. Compliance
Reguirements Remarks
No. Yes No N/A"
E. General House keeping
ls cleaning and sanitization of dustbins done as per
1.
standard procedure?
ls general housekeeping done as per standard
2
procedure?
lf any above mentioned activity outsourced, is
3.
aooroved contract available?
ls Medicines are available in the first-aid box as
per the list and periodically checking records
available?
Observation
Authors Desionation Sionature Date
Preoared BV Officer QA fljMs-' 2l)ob 74L?-
Checked Bv Executive QA W'r'0,- )l,bb \41>L
Apbroved By Head QA '"J&&_ 'zL) oblt-aLL
Authorized Bv Head Plant ,a)' oL LaL 2-
Format No. : QA,/001/F01-00

fM-AsLqn cq?i
LUCENT BIOTECH LIMITED rurr-rrr

't65/3, Nalhera, Anantpur, Puhana, Roorkee, Distl: Haridwar (Uftarakhan dl
Oepartment QUALITY ASSURANCE

QA/006-03 LzlDblL('ll, >>l b|ltoLq- QA/006-02 03 71 o179
Sr. Compliance
No. Yes No N/A
F. Other Records
Are there a written procedures for Medical
1.
Checkup of Employees
2. Examine allthe employees l\4edical Reports

Isthere a list available stating the names of
3. employees who have undergone Pre-employment,
routine l\4edical examination?
Are all the agreements pertaining to the
requirement of the Company maintained properly?
Are there procedures for washing and
5.
maintenance of Linen and lockers?
6. Check the Linen records
Are the records complete with respect to thl

following?
7 . All relevant signatures are present.
. "All relevant data are present
. All relevant data are accurate.
Are there procedures for safety and fire fighting

8
available?
ls enough awareness created by company for

maintaining safety and fire fighting?
I ls training imparted on fire fighting technici? Are
the records maintained?
Observation
Authors Desiqnation Si.q nature Date

PreDared Bv Officer QA U tEL-. t tl ohl laLL
Checked Bv Executive CIA ur\- r)lobl tat -
Approved By Head QA M"4 z2-l obl riLL
Authorized Bv Head Plant ",L) 'LLl ob| \4'l- t-
Formdt No. : QAJOOI/FO1-00
MASTER I]OPY
STANDARD OPERATING PROCEDURE For Restricted CircJlation
LUCENT BIOTECH LIMITED {uNlr-r)


QA/006-03 L3l oQ ac,t- \->lD6lra2-+ QA/o06"02 03 72 of 79
Sr, Compliance
No. Yes No N/A
G. StatutoryRequirements
Are documents pertaining to the following
maintained and updated?
1.
. Factory Inspectorate
. Safety
2 ls company license available?
3. ls Dollution bond certiticate license available?
4. Attendance register of employee
5 ls Labor contract available?
6. Does contract labor used for critical activities?
Observation
Sr. Compliance
No.
Requirements I Rerfarks
Yes No N/A
H. Training Program
ls trai0ing need identified for all employees? w.r.t
1.
Department wise?
ls training given to employees as per need
2.
identification and evaluated/re-evaluated?
Are training for safety practices given to
3.
employees?
ls Training of contract labor and person?
ls lnduction training records for all employees

5 I
available? t
ls initial need base training record attached with
6
induction training file?
Authors Desiqnation Siq natu re Date

PreDared Bv Officer QA (L .)uV al oL l.aL'l-
Checked Bv Executive QA rr.4),." u oh toLL
Approved By Head QA ' fdrr U"l rt
"L)r-
Authorized Bv Head Plant 72 ol> \a1' L-
Format No : QAJ001/F01-00
MASTER COPY

165/3, Nalhera, Anang)ur, Puhana, Roorkee, Distt: Haridwer (uttarakhand)

QA/o06-03 >U oL /\,o22 zt-/ohlr'er1. QA/o06-02 03 73 ol 79
Sr. Name of the Auditor Signature D ate

No.
Format No. OA,/006/F09-01
Authors I Desionation Sionature Date

Prepared Bv Officer QA uNy---- '?-'l Db Lo'LL
Checked Bv Executive QA 4rn''\n^ Dtlob loLl-
Approved By Head QA "M4-
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Format No. : QAJ001/F01-dO
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STANDARD oPERATING PRocEDURE t For Restricted Circulation'
LUCENT BIOTECH LIMITED ruNrrrrt
165/3, Nalhera, Anqntpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhan d)

QA/006-03 alobl ,^, > >>'lo6lw* QA/006-02 03 75 of 79
Annexure-Xl
B
Department
LUCENT BIOTECH LIMITED ruNrr.r)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (utlarakhand)
QUALITY ASSURANCE
Title Self lnsDection Circular Paqe No- of
Date;
To,
All Auditors and Auditee Department

Kindly do the self inspection as details of the self inspection program is tabulated below:
Date of Self Inspection

Auditee Department
Time
I I
Name of Auditors
Name of Observer
(lf any)
Best Regards,
Head QAJ Designee Acknowledge by (Audit team)
Acknowledge by
(Department Head / Designee)
Format No QAJ006/Fl 1-00

Prepared Bv Officer QA vrNv 2l ob)xzL
Checked Bv Executive QA uDl 1l ob I )-)- ?-
Approved By Hea'd QA W+- tL'L zt!
'tl r-yo1,L
Zl o6l
Authorized Bv Head Plant -4,J-
I Format No :QA,/OO1/FO1-OO
STt;i COPY
STANDARD OPERATING PROC For Restricteil Cire ulation
LUCENT BIOTECH LIMITED ruHrr.rl

'165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Hari4war (uttarakhan d)

QA/006-03 )-3)aL l6z:- ts.) oLlwz-f QA/o06-02 03 76 ot 79
Annexure-Xll
LUCENT BIOTECH LIMITED luNrr-r)

@ 165/3, Nalhera, Anantpur, Puhana, Roorkee, Disti: Haridwar (Uttarakhand)
Title Audit Closinq ReDort Paqe No. of
Self lnspection Closure Report
All the Corrective and Preventive action taken for the audit Doint have been reviewed. The
CAPA are monitored for the effectiveness and found satisfactory /not satisfactory
Based on the above observation, the self inspection conducted in the month .. ...... Year......
is closed / still ooen.
lf CAPA not closed further CAPA decided: Yes /No
CAPA:
Target completion Date:
Responsible Department (Sign/Date)'
Final Closing:
I
Head Quality Assurance
Format No OA,/006/F12-00
Authors , Desionation -sionature Qate

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Checked Bv Executive QA Vrt"tL nt I utl x?L
Approved By Head QA "lf$4- LLI D61 X.r2--
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Format No. : Otu001/F01-00
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ISTANDARD OPERATING
AETfl qqBY
t
PRO-EDURE For Restricted CirGulation

'165/3, Nalhera, Anantpur, Puhana, Roorkee, Disft: lbridwar {Uttarakhan d)

QA/o06-03 Alobl*.r- 2rJ oLlwzl QA/006-02 03 78 of 79
Annexure-XlV
LUCENT BIOTECH LIMITED (uNrr-rl
@ 't65/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haddwar (Uftarakhand)
Title Certification for performing self inspection Page No- _ of_
Certification for performing self inspection
This is to certify that

Mr./l\4s.
based on his/her qualification and experience , He/ She has the experience to conduct the self-
Certified by:
Head - Quality Assurance Date
Approved by:
Head - Plant Date
Format No. OAJ006/F14-00
Authors Desionation -siqnature Date

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Checked By Executive QA u'11 al Dt)
Approved By Head QA
I
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Self Inspection

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MASTER COPY

STANDARD OPERATING PROCEDURE For Restricted Circulation

LUCENT BIOTECH LIMITED {uNrr-u)

Department OUALITY ASSURANCE

3.1 The Audit Team shall be responsible for:

3-2 fhe QA personnel shall be responsible for

3.3 The Head QA shall be responsible for:

LUCENT BIOTECH LIMITED {uNrr-r)

Department OUALITY ASSURANCE

3.4 The Auditee shall be responsible for:

4-'l Head QA is accountable for implementation and compliance of oP.

5.'1.1 Human Resources.

5.1.2 Storage of Raw materials, Packing materials, intermediates and finished

5.1.3 Production and in process controls

5.1.4 Quality Control/QualityAssurance

Authors Desisnation -siqnature Date

LUCENT BIOTECH LIMITED tuHtr-ttt

Department QUALITY ASSURANCE

5.1.1 1 Validation and revalidation programmes.

5.1.12 Calibration of instruments or measurement systems.

5.1.13 Complaints management.

5.1.14 Recall procedure.

5.1.15 Premises/plant facility including personnel facilities.

5.1.16 Maintenance of buildings and machineries.

5-1.18 Resu[s of previous self-inspections and any corrective to" ,"*.n.

5.2.2 Un-Announced Inspection: This type of inspection Fhall be conducted on

Authors Desiqnation Siqnature Date

Department QUALITY ASSURANCE

5.4.2 Experience: Minimum 5 years experience of pharmaceutical industries.

'Autbors Desiqnation sionature Date

LUCENT BIOTECH LIMITED ruNtr )

Department OUALITY ASSURANCE

major aud Re-current market coinplaints or Re-current product failure / rejections

5.12 An auditor from QA department shall bepresentinall inspection.

Authors Desionation Siqnature Date

Department QUALITY ASSURANCE

5.17.'1.2 Consumer or may result in significant deviations in the safety, identity,

Authors , Desiqnation Siqnature , Date

Department OUALITY ASSURANCE

5.17.2.1 Deficiencies which could potentially cause adverse conseq uences to

Authors Desiqnation Siq-oatu re )ate

LUCENT BIOTECH LIMITED {uNrr- )

Department QUALITY ASSURANCE

QAJo35/F01 titled "Corrective and Preventive Actions Form (CAPA) .

I s.za ntt CAPA shall be closed within 90 workifig days.

Authors Desiqnation Siq{ature Date

LUCENT BIOTECH LIMITED tuNrr.u)

Department OUALITY ASSURANCE

Sr.No. Annexure Title

3 Annexure-lll List Of Self Inspection Auditors

Annexure-lV Audit Checklist of Warehouse department

5 Annexure-V Audit Checklist of Production

6 Annexure-Vl Audit Checklist of QC department

7 Annexure-Vll Audit Check List of QA Department

Audit Check List of Engineering & Maintenance

10 Annexure-X Self Inspection Audit Report

11. Annexure-Xl Self-lnspection Circular

12 Annexure-Xll Audit Closing Report

Compliance Report of Non-Compliance Raised During

14. Annexure-XlV Certiflcalion Of Performing Self inspection

Authors Desiqnation Sionature Date'

Format No. : QAJOOIiFOI-OO I

LUCENT BIOTECH LIMITED ruNrr-n)