BLUECRAFT AGRO PRIVATE LIMITED

YAMUNANAGAR, HARYANA

Standard Operating Procedure DOC No. : P/830/02

Title: Document & Data Control Page 1 of 14
Rev No: 02
Effective Date 17.04.2018

1. Objective: To lay down a procedure for control of documented Information

2. Scope: This Standard Operating Procedure is applicable for the control of Documented
Information at the Bluecraft Agro Private Limited

3. Responsibility: All HODs shall be responsible to follow this SOP for maintaining control on all
Documented Information or records. Documentation personnel of all departments shall be
responsible to maintain (or to control) the Documented Information as per this SOP and shall
review the Documented Information for compliance with the relevant documentation
procedures.

Head departments and documentation Executives shall be responsible for compliance of this SOP.

4. Accountability: System coordinator shall be accountable for implementation of this SOP.

5. Abbreviations and Definitions

BAPL- Blue craft Agro
QP- Quality Procedure
QA/QC- Quality Assurance/Quality Control
PR- Production
ENGG/ MTC : Engineering and maintenance
ST : Stores
PU: Purchase
HR: human resources
MK/SA: marketing and sales
LAB : laboratory
STPs : Standard Test Procedures
SOPs : Standard Operating Procedures
SMF : Site Master File
VMP : Validation Master Plan

Documented Information :
Controlled Quality Documented Information like BMR, SOPs, Specifications & STPs
Protocols, etc.

Prepared by Checked by Approved by

Executive- QA Executive- QA Head- QA
 BLUECRAFT AGRO PRIVATE LIMITED
YAMUNANAGAR, HARYANA

Standard Operating Procedure DOC No. : P/830/02

Title: Document & Data Control Page 2 of 14
Rev No: 02
Effective Date 17.04.2018

Master Copy :
The original set of controlled Documented Information or written procedures which shall be
retained at Quality Assurance and shall always possess the stamp ‘MASTER COPY’ on the
back side of whole document.

Controlled Copy :
The photocopy of the master copy of controlled Documented Information(like SOPs, STPs etc.)
or written procedures which shall be distributed to the user department(s) as a part of
document distribution procedure and shall bear a stamp as "Controlled Copy"
and initials of the concerned personnel. These Documented Information are controlled
Documented Information and are retrievable whenever superseded.
Uncontrolled Copy :
The photocopy of master copy of controlled Documented Information or written procedures
which shall be given to any department or person for reference purpose only. These
Documented Information are not controlled Documented Information; hence are not retrievable.

6. Procedure
All Documented Information shall be the part of QMS Documented Information and QMS shall
comprises the followings:

6.1 Quality Manual: The Quality Manual shall contain a statement of the company’s Quality
Policy and Quality Objectives of the organization. It shall include the systems being followed
for the implementation of the Quality Policy. The organograms, responsibilities and authorities
of the personnel operating the systems shall also be indicated in the manual. Quality Manual
shall be prepared by CFT personnel/SYSTEM COORDINATOR and shall approved by Unit
Head.

6.2 Master Documented Information: These are detailed Documented Information for
implementation of Quality Management System covering all activities that individually or
collectively influence the quality of a product, whether directly or indirectly. These include facility
Layouts, Master Formula Records (MFR), Batch Processing Records (BPR), Specifications and
Standard Test Procedures of materials and product,

6.3 Records: Records can be categorized as:

Primary records (original raw data):g. executed Batch Records, Analytical Records, Log
Books, Maintenance Records, Calibration Records

Prepared by Checked by Approved by

Executive- QA Executive- QA Head- QA
 BLUECRAFT AGRO PRIVATE LIMITED
YAMUNANAGAR, HARYANA

Standard Operating Procedure DOC No. : P/830/02

Title: Document & Data Control Page 3 of 14
Rev No: 02
Effective Date 17.04.2018

Secondary records/Documented Information: these are generated as report/certificate using

primary raw data. All Documented Information shall be identified and traced by a unique title &
unique document number. Any allotted document number must not be allotted to any other
document.All master copies shall be kept with System coordinator .
User shall prepare Documented Information or make data entry in records by considering
following points:
 Record activity immediately but correctly.
 Check entry of records for accuracy.
 Sign and date immediately on record.
 Check if deviation exists.
 Don’t destroy record/ evidence in case of deviation or OOS.
 Co-operation during investigation.

Checker/ Reviewer shall check/ review the Documented Information by considering following points:
 Verify record for adequacy/ accuracy.
 Check technique/ skill of user periodically.
 Sign and date for review.
 Report investigation, deviation, incident etc. promptly.
 Advise how to rectify/ correct the error in data entry.
 Guide user in technique & skill.

Approver shall approve the document by considering following points:

 Verify adequacy/ accuracy/ sensitivity of document.

 Verify against guidelines/ regular standards/ SOPs/ Pharmacopoeia.
 Sign and date on approval of document.
 Guide /Assist in investigation.

Generation of Documented Information:

All the Documented Information shall be prepared or generate as per their respective SOPs.

Master copies of Documented Information

Master copy shall be an approved original copy of Documented Information and shall be
prepared by stamping of “MASTER” stamp in “Red color” (as described below) on each page

Prepared by Checked by Approved by

Executive- QA Executive- QA Head- QA
 BLUECRAFT AGRO PRIVATE LIMITED
YAMUNANAGAR, HARYANA

Standard Operating Procedure DOC No. : P/830/02

Title: Document & Data Control Page 4 of 14
Rev No: 02
Effective Date 17.04.2018

of the document position without obscuring any text.Master copy shall be kept in the custody
of System coordinator

Controlled copies of Documented Information

Control copy shall be prepared by photocopy of master copy with stamping of“
CONTROLLED ” stamp in “blue colour”
Controlled copy is distribution copy of master Documented Information and shall be distributed to
users which are mentioned on distribution column of individual SOP for their intended use.

Uncontrolled copies of Documented Information

Uncontrolled copy shall be prepared by photocopy of master copy with stamping (as described
below) of “UNCONTROLLED COPY” in “blue colour”
Uncontrolled copy shall be distributed on need as a reference copy for external regulators and
concerns.

Issuance & Control of Documented Information

All Documented Information including validation Documented Information like validation

protocols/ reports, qualification Documented Information, etc. shall be under the control of
Documentation Cell of Quality Assurance department.
Like other controlled Documented Information, master copies of the validation Documented
Information shall also be retained by Documentation Cell of system coordinator.
Controlled copies of these Documented Information, if needed, shall be distributed to user and/
or functional department(s).Documented Information like SMF, VMP, Quality Policy and
Quality Manual shall be kept at the Documentation Cell of System coordinator.

All the Calibration data of equipment / instruments shall be kept / maintained by the QA
department e.g. QA shall maintained all the data of calibration for thermometers, gauges, etc.
QC shall maintain all the Calibration data of its instruments such as Balance etc.

A printed hard copy of analytical & processing data, duly signed by operator shall be preserved
along with the respective Documented Information e.g. Chromatograms, and electronics print
outs (if any).All data shall be executed by doer, checked by supervisor or above and verifed by QA (if
applicable).Backup data shall be taken on the compact discs or space access given by IT

Prepared by Checked by Approved by

Executive- QA Executive- QA Head- QA
 BLUECRAFT AGRO PRIVATE LIMITED
YAMUNANAGAR, HARYANA

Standard Operating Procedure DOC No. : P/830/02

Title: Document & Data Control Page 5 of 14
Rev No: 02
Effective Date 17.04.2018

personnel by time to time. Electronically generated data shall not be modified / changed without
authorization from Head QA.

Issuance of all the controlled document govern by QA documentation cell. Issuance of formats and
BMRs shall be as described in their respective SOPs

Distribution and Retrieval of the Documented Information

All the controlled Documented Information shall be distributed and retrieved by Documentation Cell of
QA.
Distribution and retrieval of the concerned document shall be done using the form titled ‘Document
Distribution and Retrieval Record’.
The retrieved controlled copies of the document shall be destroyed by Documentation Cell of QA.

Archiving of Documented Information

Arrangement of all the Documented Information shall be with respective department wise that can be
identity and easily traceable. All the batch records received should be reviewed and then store in
designated area according to the Batch No.

The master copy of superseded document shall be retained by the Q.A. and stamped as “OBSOLETE”
in center of document on every page. A list of obsolete Documented Information shall be prepared.

Retention of Documented Information

Records, superseded Documented Information shall be preserved and retained for the period as
described in table below:

Prepared by Checked by Approved by

Executive- QA Executive- QA Head- QA
 BLUECRAFT AGRO PRIVATE LIMITED
YAMUNANAGAR, HARYANA

Standard Operating Procedure DOC No. : P/830/02

Title: Document & Data Control Page 6 of 14
Rev No: 02
Effective Date 17.04.2018

S.No Type of Document Retention Period Destruction

01 Calibration Records 3 years Yes
02 Batch Processing Record After 6 months of Product Yes
Expiry
03 Validation Record Permanent Not to be destroyed
04 Media Fill Record Permanent Not to be destroyed
05 Validation Master Plan Permanent Not to be destroyed
06 Site Master File Permanent Not to be destroyed
07 Master Formula Record Permanent Not to be destroyed
08 Vendor Audit Report 3 years Not to be destroyed
09 Standard Operating Procedure Permanent Not to be destroyed
10 Training Records 1 year after resignation of Yes
employee
11 Internal Audit Record 3 Years Yes
12 Controlled Copies of Master Destruction on Retrieval Destruction on Retrieval
Documented Information
13 Stability Data Permanent Not to be destroyed
14 Organograms 3 years Yes
15 Specifications, STP 3 Years Yes
16 Filled Formats & Records 3 Years Yes

Note: The retention period shall starts after superseded of Documented Information

Destruction of Documented Information and Records

Retrieved controlled copies of superseded Documented Information shall be destroyed by
Documentation Cell of QA manually relevant recording shall be done on the form Document
Distribution and Retrieval Record.

Prepared by Checked by Approved by

Executive- QA Executive- QA Head- QA
 BLUECRAFT AGRO PRIVATE LIMITED
YAMUNANAGAR, HARYANA

Standard Operating Procedure DOC No. : P/830/02

Title: Document & Data Control Page 7 of 14
Rev No: 02
Effective Date 17.04.2018

Master copies of all the superseded Documented Information shall be stamped with ‘OBSOLETE’ by
Documentation Cell of SYSTEM COORDINATOR on the front side (on text part) of all the pages, in
red ink.
All the obsolete master copies of superseded Documented Information shall be maintained for a period
of as mentioned from the date of obsolescence of the document. After completion of retention period
obsolete master copies shall be destroyed by documentation cell SYSTEM COORDINATOR
manually.
Documentation Cell of SYSTEM COORDINATOR shall record the details of destruction of obsolete
master copies/ Documented Information in ‘Documented Information/Data Destruction Record’

Handling of External Origin Documented Information

External origin Documented Information such as pharmacopeias, books, reference guideline etc. shall
be issued, retrieved and controlled by SYSTEM COORDINATOR.
Issuance record of these documents shall be maintained by SYSTEM COORDINATOR.
In case new versions of these Documented Information shall be published then SYSTEM
COORDINATOR shall procured these new versions of Documented Information. SYSTEM
COORDINATOR personnel shall be retrieved the old version of these Documented Information, stamp
the control copy on new versions of these Documented Information and issued the control copy of
these Documented Information to the relevant department.

Forms and Records

Issuance record of uncontrolled copies – Annexure-I
Issuance record of controlled Documented Information – Annexure-2
List of obsolete Documented Information – Annexure-3
Document Distribution and Retrieval Record – Annexure-4
Documented Information/ Data Destruction Record – Annexure-5

Distribution
Master copy- Quality Assurance
Controlled copies – Quality Assurance, Production, Stores, Engineering, & Human Resource

Prepared by Checked by Approved by

Executive- QA Executive- QA Head- QA
 BLUECRAFT AGRO PRIVATE LIMITED
YAMUNANAGAR, HARYANA

Standard Operating Procedure DOC No. : P/830/02

Title: Document & Data Control Page 8 of 14
Rev No: 02
Effective Date 17.04.2018

History

Date Revision Number Reason for Revision

00 New SOP

Prepared by Checked by Approved by

Executive- QA Executive- QA Head- QA
 BLUECRAFT AGRO PRIVATE LIMITED
YAMUNANAGAR, HARYANA

Standard Operating Procedure DOC No. : P/830/02

Title: Document & Data Control Page 9 of 14
Rev No: 02
Effective Date 17.04.2018

Annexure-1

Issuance Record of Uncontrolled Copies

S.No Date of Name of Document Issued To Issued By Remarks

Issuance

Prepared by Checked by Approved by

Executive- QA Executive- QA Head- QA
 BLUECRAFT AGRO PRIVATE LIMITED
YAMUNANAGAR, HARYANA

Standard Operating Procedure DOC No. : P/830/02

Title: Document & Data Control Page 10 of 14
Rev No: 02
Effective Date 17.04.2018

Annexure-2
Issuance Record of Controlled Documented Information

S.No Date of Name of Controlled Issued To Issued By Retrieved Remarks

Issuance Document By/on

Prepared by Checked by Approved by

Executive- QA Executive- QA Head- QA
 BLUECRAFT AGRO PRIVATE LIMITED
YAMUNANAGAR, HARYANA

Standard Operating Procedure DOC No. : P/830/02

Title: Document & Data Control Page 11 of 14
Rev No: 02
Effective Date 17.04.2018

Annexure-3

List of Obsolete Documented Information

S.No Date Name of the Document Docment No. Signature/Date

Prepared by Checked by Approved by

Executive- QA Executive- QA Head- QA
 BLUECRAFT AGRO PRIVATE LIMITED
YAMUNANAGAR, HARYANA

Standard Operating Procedure DOC No. : P/830/02

Title: Document & Data Control Page 12 of 14
Rev No: 02
Effective Date 17.04.2018

Annexure-4

Document Distribution & Retrieval Record

Title: Doc. No.: Loction:

Rev
.No Distribution Record Retrieval Record
Controlled Destroyed By
Copy No Received By Distributed By Retrieval From
Dept. Sign Dept. Sign Dept. Sign

Prepared by Checked by Approved by

Executive- QA Executive- QA Head- QA
 BLUECRAFT AGRO PRIVATE LIMITED
YAMUNANAGAR, HARYANA

Standard Operating Procedure DOC No. : P/830/02

Title: Document & Data Control Page 13 of 14
Rev No: 02
Effective Date 17.04.2018

Annexure-5
Document/ Data Destruction Record

S.No Document Type Reason for Approved Destruction On Remarks

Destruction By (QA
Head)

Prepared by Checked by Approved by

Executive- QA Executive- QA Head- QA
 BLUECRAFT AGRO PRIVATE LIMITED
YAMUNANAGAR, HARYANA

Standard Operating Procedure DOC No. : P/830/02

Title: Document & Data Control Page 14 of 14
Rev No: 02
Effective Date 17.04.2018

Prepared by Checked by Approved by

Executive- QA Executive- QA Head- QA