T

Calibration of Balance
Location Format No : APL/ BAL/02/01A
Model No. Date of Issue

Capacity :120 GM Date of Review : Not Later Than 01.01.
Make Frequency
Code No Responsibility
DATE 1 gm 5 gm 10 gm 20 gm 50 gm 100 gm Checked by
Limit : + 0.01 of the individual weight

Head of the dept.
Prepared by Checked by Approved by

Location :QC Department Format No : APL/ BAL/02/02

Model No. :200 D Date of Issue
Capacity 200 gm Date of Review
Make :Dhona Frequency
Code No :AEQ 20 Responsibility
For the Month of______________
WEIGHTS
DATE CHECKED BY
10 mg 50 mg 100 mg 1 gm 10 gm 50 gm
Limit : + 1 % of the individual weight up to 50 mg

+ 1 % of the individual weight of 100mg and above.

RECORD OF PEST -O-FLASH
Location: Format No: APL/P-0-F/02/02

Make : Technocrats Date of Issue: 01.07.2006
Code No: Date of Review: Not later than 01.07.2008
Frequency of check: Daily Responsibility:
Date Time Number of insect Checked By
c\beena\joseph\others\448929272.xls
Calibration of pH Meter
Location : Format No : APL/CAL/08

Make : Date of Issue : 01/08/06
Code No : Date of Review : 01/08/08
Responsibility : Frequency Of : Daily
calibration
DATE pH 4.0 pH 9.2 DONE BY
Limit : + 0.02 of the pH
Prepared by checked by Approved by
AUTOCLAVE CALIBRATION
Department : Quality control Format No: APL/A-CAL/12

Section : Microbiology Date of Issue: 01.09.2005
Responsibility : Microbiologist Date of Review: Not later
than Sept 2007
Biological indicator used : Bacillus stearothermophillus Batch No. :

Frequency of Calibration : Quarterly Mfg. Date :
Calibrated on : Exp. Date :
Next calibration due on :
Vial of bacillus Autoclave cycle details Incubation details

stearotherm - Observation
ophilus in
Date Pressure Time Date Temp Period
Empty cycle 15 lbs. 55-60ºC 5 days
Load 15 lbs. 55-60ºC 5 days

description
Positive control NA NA 55-60ºC 5 days
15 LBS 5 MIN 55-60ºC 5 days
Key :-
NA : Not applicable
Microbiologist : Head of the department
C:\beena\joseph\others\448929272.xls
Date : Date :
FUMIGATION RECORD
Location : Housekeeping Format No: APL/FUM/06F
Frequency : Monthly Date of Issue: 01.07.2004
Responsibility : Housekeeping supervisor Date of Review: Not later
than 01.07.2006
Chemical used potassium permanganate: Formaldehyde (1:4)
Qty of Qty of Done

Date Areas KMnO4 Time
formaldehyde by
Change room ladies
Change room gents
Change room staff
Toilet ladies
Toilet gents
Canteen
Qty of Qty of Done

formaldehyde by
Change room ladies
Change room gents
Change room staff
Toilet ladies
Toilet gents
Canteen
Head of the department
MIGATION RECORD
than 01.07.2006
Checked by
Checked by
Approved by
FUMIGATION RECORD
Location : Stores Format No: APL/FUM/06E
Frequency : Fortnightly Date of Issue: 01.07.2004
Responsibility : Stores supervisor Date of Review: Not later
than 01.07.2006
Qty of Qty of Done

formaldehyde by
Sampling LAF room
Men entry room
Material entry room
Dispensing LAF room
Men entry room
Material entry room
Qty of Qty of Done

formaldehyde by
Sampling LAF room
Men entry room
Material entry room
Dispensing LAF room
Men entry room
Material entry room
MIGATION RECORD
Checked by
Checked by
Approved by
FUMIGATION RECORD
Location : Capsule department Format No: APL/FUM/06D
Responsibility : Capsule supervisor Date of Review: Not later
than 01.07.2006
Qty of Qty of Done

Date Areas KMnO4 Time Checked by
formaldehyde by
Capsule manufacturing
Capsule filling
Qty of Qty of Done

formaldehyde by
Capsule filling
Qty of Qty of Done

formaldehyde by
Capsule filling
Qty of Qty of Done

formaldehyde by
Capsule filling
FUMIGATION RECORD
Location : Quality control department Format No: APL/FUM/06C
Frequency : Weekly Date of Issue: 01.07.2004
Responsibility : Microbiologist Date of Review: Not later
than 01.07.2006
Qty of Qty of Done

formaldehyde by
Microsection LAF room
Air lock
Qty of Qty of Done

formaldehyde by
Air lock
Qty of Qty of Done

formaldehyde by
Air lock
Qty of Qty of Done

formaldehyde by
Air lock
MIGATION RECORD
than 01.07.2006
Checked by
Checked by
Checked by
Checked by
Approved by
FUMIGATION RECORD
Location : Liquid department Format No: APL/FUM/06B

Responsibility : Liquid supervisor Date of Review: Not later
than 01.07.2006
Qty of Qty of
formaldehyde
Liquid manufacturing
Material Entry
Liquid filling
Men entry (Air lock)
Bottle washing
Qty of Qty of
formaldehyde
Liquid manufacturing
Material Entry
Liquid filling
Men entry (Air lock)
Bottle washing
FUMIGATION RECORD
Location : Tablet department Format No: APL/FUM/06A

Responsibility : Tablet supervisor Date of Review: Not later
than 01.07.2006
Qty of Qty of Checked

formaldehyde by
Granulation section
Lubrication section
Compression area I
Compression area II
Compression area III
Coating section
Inspection room - I
Inspection room - II
Bulk packing I
Bulk packing II
Blister room
Stripping room
Granulation section
Lubrication section
Compression area I
Compression area II
Compression area III
Coating section
Inspection room - I
Inspection room - II
Bulk packing I
Bulk packing II
Blister room
Stripping room

VELOCITY RECORD OF AIR CURTAINS
Make : Technocrats
Frequency : Once in 3 months.
Responsibility : Maintenance
Department
Aircurtain No 1/5 Location : Material Entry

Velocity at Velocity at
Date
the Top the Bottom
Aircurtain No 2/5 Location : Men Entry (Change room)

Date
the Top the Bottom
Aircurtain No 3/5 Location : Production Entry

Date
the Top the Bottom
Aircurtain No 4/5 Location : QC Department / Canteen

Date
the Top the Bottom
Aircurtain No 5/5 Location : Visitor Entry

Date
the Top the Bottom
Head of the department.

RECORD OF FUMIGATION
Location : Format No.
Frequency : Date Of Issue
Procedure : Date Of Review
Standard quantity of Formaldehyde solution required :
Standard quantity of Potassium Permangnate required :
Quantity of
Volume of
Date of Potassium AHU shut Time of
Month Formaldehyde
fumigation Permangnate down by fumigation
solution
weighed
HEAD OF THE DEPAR
Prepared By Checked By Approved By
: Not Later Than 01/07/2008
Checked By
HEAD OF THE DEPARTMENT
Approved By
TEMPERATURE AND RELATIVE HUMIDITY RECORD
Location: Capsule filling / mfg.area Format No: APL/T&RH/03/02
Responsibility: Department In-charge Date of Issue: 01.08.2006
Date of Review: Not later than 01.08.2008
TEMPERATURE RELATIVE HUMIDITY

CHECKED
DATE TIME
BY
*Temperature & Humidity should be recorded atleast thrice in a shift (Every 3 hours)
Temperature - 20 °C± 5°C , Humidity - 50 °C ± 5°C
RECORD OF TEMPERATURE & PRESSURE DIFFERENTIAL ACROSS LAF
Location : Format No : APL/LAF/04/02
Model No : Date of Issue : 01.08.2006
Sr. No. : Date of Review : Not later than 01.07.2008
Responsibility :
Frequency : Daily
TEMPERATURE MAGNEHELIC GAUGE

TIME IN CHECKED
DATE Limit : READING
HOURS. BY
20oC ----- 25oC Limit : 10- 20 mm
C\beena\joseph\others\448929272.xls
Note: 1) Run LAF for minimum 10 minutes. 2) The operation should start only after the
needle of magnehelic gauge is stable.3) If magnehalic gauge reading is less than 5 it
means filter is leaking 4) If magnehelic gauge reading is more than 20, it means filter &
prefilters are choked and needs cleaning.
Head of the Dept.

Senior Chemist Q.C. Incharge Q.A/Q.C. Manager
C\beena\joseph\others\448929272.xls
RECORD OF PEST -O-FLASH
Location: Format No: APL/P-0-F/02

Make : Technocrats Date of Issue: 01.07.2004
Code No: Date of Review: Not later than 01.07.2006
Frequency of check: Daily Responsibility:
Date Time Number of insect Cleaned By Checked By
Location Format No : APL/ BAL/01/01/P
Model No. Date of Issue : 01.10.2006

Capacity :100 kg Date of Review : Not Later Than 01.10.2008
Make Frequency Of
:Daily
Code No calibration
Responsibility :Store In-Charge
DATE 5 kg 10 kg 25 kg 35 kg 50 kg 75 kg DONE BY CHECKED BY
Limit : + 0.01 of the individual weight

Head of the dept.
Location :QC Department Format No : APL/ BAL/02/02

Model No.:200 D Date of Issue : 01.01.2007
Capacity 200 gm Date of Review : Not Later Than 01.12.2008
Make :Dhona Frequency :Daily
Code No :AEQ 20 Responsibility :QC Chemist
For the Month of______________
WEIGHTS
DATE DONE BY CHECKED BY
10 mg 50 mg 100 mg 1 gm 10 gm 50 gm 100 gm
Limit : + 1 % of the individual weight up to 50 mg
+ 1 % of the individual weight of 100mg and above.

T

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

T

Uploaded by

Copyright:

Available Formats

Calibration of Balance

Location Format No : APL/ BAL/02/01A

Model No. Date of Issue

DATE 1 gm 5 gm 10 gm 20 gm 50 gm 100 gm Checked by

Limit : + 0.01 of the individual weight

Prepared by Checked by Approved by

Location :QC Department Format No : APL/ BAL/02/02

For the Month of______________

Limit : + 1 % of the individual weight up to 50 mg

Prepared by Checked by Approved by

Location: Format No: APL/P-0-F/02/02

Date Time Number of insect Checked By

Prepared by Checked by Approved by

Location : Format No : APL/CAL/08

DATE pH 4.0 pH 9.2 DONE BY

Prepared by checked by Approved by

Department : Quality control Format No: APL/A-CAL/12

Biological indicator used : Bacillus stearothermophillus Batch No. :

Vial of bacillus Autoclave cycle details Incubation details

Empty cycle 15 lbs. 55-60ºC 5 days

Load 15 lbs. 55-60ºC 5 days

Positive control NA NA 55-60ºC 5 days

15 LBS 5 MIN 55-60ºC 5 days

Microbiologist : Head of the department

Prepared by Checked by Approved by

Chemical used potassium permanganate: Formaldehyde (1:4)

Qty of Qty of Done

Change room ladies

Change room gents

Change room staff

Qty of Qty of Done

Change room ladies

Change room gents

Change room staff

Prepared by Checked by Approved by

Chemical used potassium permanganate: Formaldehyde (1:4)

Qty of Qty of Done

Sampling LAF room

Men entry room

Material entry room

Dispensing LAF room

Men entry room

Material entry room

Qty of Qty of Done

Sampling LAF room

Men entry room

Material entry room

Dispensing LAF room

Men entry room

Material entry room

Prepared by Checked by Approved by

Chemical used potassium permanganate: Formaldehyde (1:4)

Qty of Qty of Done

Qty of Qty of Done

Qty of Qty of Done

Qty of Qty of Done

Prepared by Checked by Approved by

Chemical used potassium permanganate: Formaldehyde (1:4)

Qty of Qty of Done

Microsection LAF room

Qty of Qty of Done

Microsection LAF room

Qty of Qty of Done

Microsection LAF room