Documentation-Data-Control

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IN
STANDARD OPERATING PROCEDURE
Restricted Circulation
Department: Quality Assurance
TITLE: PROCEDURE FOR DOCUMENTATION AND DATA CONTROL
SOP No. SOP/QA/005 Revision No. 00
Effective Date Supersedes No. NIL
Review Date Page No. 1 of 22
1.0 OBJECTIVE:
To lay down a Procedure for Documentation and Data Control.
2.0 SCOPE:
This SOP is applicable to Documentation and Data Control for all Department of
www.Pharmascholars.in.
3.0 RESPONSIBILITY:
QA (Officer/ Executive): Preparation, Distribution, Revision, Retrieval and Destruction of this SOP.
QA Manager: Review, Training and effective implementation of this SOP to all concerned
Departments.
Respective Departments: Preparation and Revision of Departmental Documents.
(Officer/ Executive)
Respective Departments: Review, Training and Effective Implementation of Departmental
Documents.
4.0 ACCOUNTABILITY:
Respective Departments Heads: To ensure Training and effective Implementation of Departmental
Documents.
Head QA: To ensure Compliance with the SOP.
5.0 DEFINITIONS:
5.1 Document:
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Officer/Executive Department Head Head Quality Assurance
Name
Signature
Date
FORMAT No. SOP/QA/001/F01-00
WWW.PHARMASCHOLARS.IN
The definition of Good Documentation Practice (GDP) describes standards by which

documentation is created and maintained in the pharmaceutical industry. Although the U.S. Food
and Drug Administration (FDA) sets some GDP standards, others fall under the current Good
Manufacturing Practice (cGMP). All pharmaceutical, bioscience and healthcare companies, as
well as their vendor partners, must observe GDP or face warnings or penalties levied by the FDA.
6.0 PROCEDURE:
Note: Do not use Gel / Fountain Pen for Signing and Filling the documents.
6.1 DOCUMENTS TRAINING, CONTROL, ISSUANCE AND RETRIEVAL:
6.1.1 All Master documents once finalized, shall be printed on A4 size plain white colored Paper
(75 GSM) using “Times New Roman” Font size 12 with Black Ink.
6.1.2 Printing of Master Documents shall be done on one side of the paper only and shall be
signed off with Blue Ink ball point pen by all stakeholders.
6.1.3 SMF, VMP and other Manuals shall be printed on A4 size White Colour Glossy Paper of
100 GSM (Except Cover Page, Cover Page shall be printed on A4 Size White Photo Paper
of 180 GSM) with Colour Printing. Printing shall be done on one side of the paper only.
6.1.4 Training shall be imparted by SME/Manager/Head of the User Department to the concerned
department and Cross-functional departments with respect to Master document.
6.1.5 Post training, Documents shall be made effective within 10 working days and effective date
shall be written in respective column of Header with Blue Ink Ball Point Pen.
6.1.6 Master copy shall be stamped as “MASTER COPY” on all pages with Blue colour ink as
per Annexure-I, Titled “Name and Specimen of Stamps for Plant Quality Assurance” and
shall sign and date with Blue Ink Ball Point Pen

Name
Signature
Date
6.1.7 After photocopying of master copy, all pages shall be stamped as “CONTROLLED COPY”
with green colour ink and sign and date with Black Ink Ball Point Pen as per Annexure-I.
6.1.8 All controlled copy of Documents / Spiral binded Log books / Registers etc. of all the
departments shall be issued by QA after receiving the Request Form for Issuance of
Documents as per format shown in Annexure-II, Titled “Request Form for Issuance of
Documents”.
6.1.9 QA shall affix issuance slip as per format shown in Annexure-III, Titled “Bound Book /
Register Issuance Slip” on the back side of front cover page of Bound Book (Registers,
Ledgers, Duplicate / Triplicate Book / Spiral binded Log Books and Pre Printed forms) and
Controlled Copy stamp shall be on the right corner of the slip.
6.1.10 In case controlled copy of Documents are to be carried out for external / internal purpose,
shall be authorized by Head QA as per Annexure-II, Titled “Request Form for Issuance of
Documents”.
6.1.11 Additional Page (for recording additional entries) shall be issued by QA after filling the
Request Cum Issuance Form for Additional Pages as per format shown in Annexure-IV,
Titled “Request cum Issuance Form for Additional Pages”.
6.1.12 QA shall maintain the Issuance, Retrieval and Destruction Record of loose
Formats/Annexures as per format shown in Annexure-V, Titled “Formats Issuance,
Retrieval & Destruction Log”.
6.1.13 QA shall maintain the Issuance, and Retrieval of bound books/Registers or spiral binded log
books as per format shown in Annexure-VIII, Titled “Log Books/Register Issuance &
Retrieval Log”.

Name
Signature
Date
6.1.14 All retrieved copies of unexecuted documents (Annexures) issued to Plant shall be collected
by QA Department on monthly basis and destroyed with the help of Paper Shredder or
manually for disposal.
Note: Loose formats/Annexures issued on monthly basis shall be utilized within the same
month, remaining copy shall be retrieved to QA and new formats/Annexures to be issued
for the next month.
6.1.15 Log books of the plant shall be retrieved immediately after completion and at the end of
calendar year as per applicability and details of retrieval shall be recorded in Annexure-
VIII.
6.1.16 All controlled Retrieved Documents shall be archived in QA Department with lock and key
arrangements.
6.1.17 All Documents and Records shall be stored in a manner to protect them from damage, loss
and deterioration.
6.1.18 Documents & Records shall be easily retrievable.
6.1.19 All personnel shall use Black Ink Ball Point Pen for recording the data.
6.1.20 IPQA personnel shall use Green Ink Ball Point Pen for data entry in the documents (BMR
& BPR and Verification Part of Log Books / Formats / Registers etc.)
Note: Change History Log shall be part of all documents.
6.2 SPECIMENS OF STAMP:
6.2.1 Specimen of Stamps having Department name as “Quality Assurance” are for the
Documents controlled by Quality Assurance as shown in Annexure-I.
6.2.2 All Stamps shall be kept in lock & key in QA.

Name
Signature
Date
6.2.3 For Specimen of Stamps Location refer as per format shown in Annexure-VII, Titled
“Stamps Location (Specimen Copy)”.
6.2.4 MASTER COPY STAMP:
6.2.4.1 Master Copy of documents shall be stamped as ‘MASTER COPY’ in Blue color
ink below square space or right upper corner of the page provided in Header on all
the pages and shall be signed by Blue Ink Ball Point Pen.
6.2.5 CONTROLLED COPY STAMP:
6.2.5.1 Master Copy of SOP shall be photocopied and stamped as ‘CONTROLLED
COPY’ containing Copy No., Sign & Date in Green ink in the right upper corner of
the page and shall be signed by Black Ink Ball Point Pen. For issuance of
documents other than SOP “CONTROLLED COPY” stamp without Copy No.
shall be used in Green ink in the right upper corner of the page.
6.2.6 ADDITIONAL PAGE STAMP:
6.2.6.1 Additional pages shall be stamped as ‘ADDITIONAL PAGE’ in violet ink at
Footer in center and shall be signed by Black Ink Ball Point Pen with Controlled
Copy stamp at predefined place.
6.2.7 UNCONTROLLED COPY STAMP:
6.2.7.1 Copy of Document that is meant to be submitted/provided to the External Agency
(i.e. Regulatory, Customers / Partners etc.) shall be made by Photocopy of Master
Copy or executed documents (Filled BMR/BPR, Log Books, Reports and any other
executed formats etc.) by QA and shall be stamped as ‘UNCONTROLLED
COPY’ in Red Ink on left corner of the page below footer and shall be signed by
Black Ink Ball Point Pen.

Name
Signature
Date
Note: Uncontrolled copy of Documents shall not be issued within the entire
Organization for internal use.
6.2.8 OBSOLETE COPY STAMP:
6.2.8.1 Obsolete Copy shall be stamped as ‘OBSOLETE COPY’ in Red Ink in the Middle
of all the pages and shall be signed by Black Ink Ball Point Pen.
6.2.9 DISCONTINUED COPY STAMP:
6.2.9.1 Master Copy of Documents which is discontinued shall be stamped as
‘DISCONTINUED COPY’ in Red Ink at the middle of all the pages and shall be
signed by Black Ink Ball Point Pen.
6.2.10 REVIEWED STAMP:
6.2.10.1 Any Reference documents from outside Agency received at QA, shall be reviewed
and stamped with “REVIEWED” on last page at centre of footer of the document
in Violet ink and shall be signed by reviewer by Black Ink Ball Point Pen.
6.2.11 REFERENCE COPY STAMP:
6.2.11.1 When multiple copies of any executed document (i.e. filled deviation, Incident,
Change Control, training record, batch conversion note etc.) are required for filing
with other documents as reference, “REFERENCE COPY” stamp in violet ink
shall be put above header in centre and shall be signed by Black Ink Ball Point
Pen.
6.2.12 DISPLAY COPY STAMP:
6.2.12.1 Documents which are issued for display purpose shall be stamped as “DISPLAY
COPY” in Violet ink on bottom right corner.
6.2.13 APPROVED BY STAMP:

Name
Signature
Date
6.2.13.1 Any Reference documents from outside Agency like calibration certificates, shade
card, artworks which required QA Approval shall be stamped as
“APPROVED BY” in Green ink on non-text part of the page.
6.2.14 REVISION OF DOCUMENTS:
6.2.15 Any change required in the document shall be done at any time during the period after due
authorization of Change Control.
6.2.16 Periodic review of documents shall be done through change control Procedure.
6.2.17 For discontinuation of any document mention “Discontinued” in the remarks column of
Document Master List.
6.2.18 QA shall inform to Department Head prior 30 days for revision of Documents which is to
be reviewed.
Note: The soft copy of Documents shall be provided to respective departments one
month in advance from the next due date of revision.
6.3 LIFE CYCLE & DESTRUCTION OF DOCUMENTS (MASTER AND EXECUTED):

6.3.1 All the Obsolete/Discontinued hard copy of Master Document (i.e. MFR, BMR & BPR etc.)
shall be scanned and retained in soft copy with back up facility for life cycle from the date
of Obsolete/Discontinued document.
6.3.2 Hard copy of Obsolete/Discontinued Master Document shall be stored for Five years and
destruction shall be done as per format shown in Annexure-VII, Titled “Master/Executed
Document Destruction Record”.
6.3.3 After five year, Obsolete/Discontinued/Executed document shall be destroyed through
paper shredder/manually.

Name
Signature
Date
6.3.4 In case if any legal Complain/Issue is noticed then necessary documents / data covering that
complaint/issue shall be retained till the resolution of such issues.
6.3.5 Product Quality Review, Process Validation Protocols/Reports, Stability Data &
Documents, Qualification & Validation Documents for critical
Utilities/System/Equipments, Clinical Trials, Bioavailability & Bioequivalence,
Toxicological studies shall be retained till the life of the organization.
6.3.6 (BMR, BPR and Analytical data) and other product related documents and logbooks shall
be preserved up to Product Expiry plus one Year and thereafter QA shall destroy by paper
shredding machine/manually.
6.3.7 QA shall maintain the destruction record of Executed (BMR, BPR, and Analytical data).
6.3.8 All Certificates, Equipment/Machines Manuals (Original Copy) shall be retained till the life
of the organization by Quality Assurance Department with lock and key arrangements.
6.3.9 Calibration records, Equipment Log & Machine Log shall be preserved up to Five Years.
6.4 DATA CONTROL:
6.4.1 All the data maintained in software shall be protected by Password accessible to Head QA /
respective Head of the Plant specific Department/and their designee.
6.4.2 Archiving of data in External Hard Disc/ Soft Backup/ Hard Backup shall be done by IT
Department and shall be kept under lock and key.
6.4.3 The distribution of data to other than user shall be done only after approval of Head QA.
6.5 SITE MASTER FILE (SMF) AND VALIDATION MASTER PLAN (VMP):
6.5.1 The first page annexure of validation master plan Logo height 1.41” and width 2.89”.
6.5.2 The revision period for SMF & VMP shall be of 02 years, if there is any change in the
document, amended with date & page no. shall be placed with the document.

Name
Signature
Date
Document No. For site master file should be – SMH/QA/DOC/01

Document No. for validation master plan should be – SMH/QA/DOC/02
6.5.3 Annexure of the SMF & VMP shall be revised as and when required.
6.6 NUMBERING SYSTEM FOR MANUALS:
6.6.1 Document No. for Quality Manual shall be – SMH/QAM/01
6.6.2 Further number for Manuals shall be given in the same sequence with increase in serial
number.
7.0 ABBREVIATIONS:
QA Quality Assurance
IPQA In-process Quality Assurance
Ltd. Limited
MFR Master Formula Record
No. Number
PDF Portable Document Format
QC Quality Control
S.No. Serial Number
SMF Site Master File
SOP Standard Operating Procedure
STP Standard Test Procedure
STS Standard Test Specification
VMP Validation Master Plan

Name
Signature
Date
8.0 ANNEXURES:
ANNEXURE TITLE OF ANNEXURE FORMAT No.
No.
Annexure-I Name and Specimen of Stamps for Plant Quality Assurance SOP/QA/017/F01-01
Annexure-II Request Form for Issuance of Documents SOP/QA/017/F02-00
Annexure-III Bound Book / Register Issuance Slip SOP/QA/017/F03-00
Annexure-IV Request cum Issuance Form for Additional Pages SOP/QA/017/F04-00
Annexure-V Formats Issuance, Retrieval & Destruction Log SOP/QA/017/F05-01
Annexure- VI Stamps Location (Specimen Copy) SOP/QA/017/F07-01
Annexure-VII Master/Executed Document Destruction Record SOP/QA/017/F08-01
Annexure-VIII Log Books/Register Issuance & Retrieval Log SOP/QA/017/F09-00
9.0 DISTRIBUTION:
• Master Copy Quality Assurance Department
• Controlled Copy No. 01 Quality Assurance Department
• Controlled Copy No. 02 Quality Control Department
• Controlled Copy No. 03 Production Department
• Controlled Copy No. 04 Human Resource Department (HR)
• Controlled Copy No. 05 Engineering Department
• Controlled Copy No. 06 Warehouse Department (Store)
• Controlled Copy No. 07 Information Technology Department

Name
Signature
Date
10.0 REFERENCES:
➢ US Code of Federal Regulations, Current Good Manufacturing Practice for Finished
Pharmaceuticals (21 CFR -Part 211), Food and Drug Administration, 21 CFR, Chapter-I.
➢ FDA Q7A Good manufacturing practice Guidance for active Pharmaceutical Ingredients, Section
VI, and Documentation and Data Control.
➢ ICH Good manufacturing practice guide for API Q7, Section 6 Documentation and Records.
➢ ISO 9001-2008, Clause 4.2: Documentation requirements.
➢ Guide to GMP for medicinal products Part-1, chapter 4 Documentation PIC/S PE 009-8 (Part I).
➢ EudraLex, The Rules Governing Medicinal Products in the European Union, Volume 4, Good
Manufacturing Practice, Medicinal Products for Human and Veterinary Use.
11.0 REVISION HISTORY:

Revision Change Control Details of Changes Reason of Effective Done
No. No. Changes Date By
Rajbeer
00 Not Applicable Not Applicable New SOP 23/06/18
Singh

Name
Signature
Date
ANNEXURE–I
QUALITY ASSURANCE
NAME AND SPECIMEN OF STAMPS FOR PLANT QUALITY ASSURANCE
SPECIMEN OF SPECIMEN OF
NAME OF THE STAMP NAME OF THE STAMP
STAMP STAMP
MASTER COPY UNCONTROLLED
COPY
CONTROLLED COPY OBSOLETE COPY
CONTROLLED COPY DISCONTINUED COPY

NO.
(Only for SOP)
DISPLAY COPY REFERENCE COPY

Name
Signature
Date
SPECIMEN OF SPECIMEN OF
NAME OF THE STAMP NAME OF THE STAMP
STAMP STAMP
REVIEWED ADDITIONAL PAGE
APPROVED BY
FORMAT No.: SOP/QA/017/F01-00 Page X of Y

Name
Signature
Date
ANNEXURE–II
QUALITY ASSURANCE
REQUEST FORM FOR ISSUANCE OF DOCUMENTS
Date:
To,
The Manager QA
From:
External /
Page / Document No. of Copies Reason for
S. No. Document Title Internal
No. Required Issuance
Purpose
Prepared By Checked By Approved By

Initiating Department Head of the Department Head QA
(Sign & Date) (Sign & Date) (Sign & Date)

Name
Signature
Date
ANNEXURE–III
QUALITY ASSURANCE
BOUND BOOK / REGISTER ISSUANCE SLIP

Title of Document:
Format No.: Effective Date:
Department Name:
No. of Pages: From ______ To _______
Issued By Approved By
Officer/ Executive QA Manager QA
(Sign & Date) (Sign & Date)

Name
Signature
Date
ANNEXURE–IV
QUALITY ASSURANCE
REQUEST CUM ISSUANCE FORM FOR ADDITIONAL PAGES
Date:
To,
The Manager QA
From:
S. No. Document / Format Document / Page No. of Copies Reason for

Title Batch / Format No. Required Issuance
No.
Prepared By Checked By Approved By Additional Pages Issued By QA

Officer / Executive Head of Department Manager QA Officer / Executive
(Sign & Date) (Sign & Date) (Sign & Date) (Sign & Date)

Name
Signature
Date
TITLE : PROCEDURE FOR DOCUMENTATION AND DATA CONTROL
ANNEXURE – V
QUALITY ASSURANCE
FORMATS ISSUANCE, RETRIEVAL & DESTRUCTION LOG
Department: Month: Year:
Issuance Retrieval Destruction
Unfilled Copy Destroyed

No. of Unfilled Copies
Remarks
Format Number
By Sign & Date

Received By
Sign & Date
No. of Copies
Retrieved By
Sign & Date
Sign & Date

Checked By
Sign & Date
Format Title
Copy Issued
Retrieved
Retrieved
Issued By
No. of
Date
N

Name
Signature
Date
ANNEXURE – VI
STAMPS LOCATION (SPECIMEN COPY)
Middle of the Page, Stamp in Red Ink,

Signed by Black Ink Ball Point Pen
Left corner of the Page, Stamp in Red

Ink, Signed by Black Ink Ball Point Pen
Below Footer in center of the Page, Stamp
in Violet Ink, Signed by Black Ink Ball
Point Pen

Name
Signature
Date
REFERENCE COPY
Sign & Date:
Middle of the Page, above header, Stamp in Violet

Right Upper Corner of the Page, Stamp in
Ink, Signed by Black Ink Ball Point Pen
Blue Ink, Signed by Blue Ink Ball Point
Pen
Middle of the Page, Stamp in Red Ink,

Signed by Black Ink Ball Point Pen
Below Right Upper Corner of the Page, Stamp
in Green Ink, Signed by Black Ink Ball Point
Pen

Name
Signature
Date
Below Footer in center of the Page, Stamp in Right Corner of the Page, Stamp in Violet
Violet Ink, Signed by Black Ink Ball Point Ink
Pen
ADDITIONAL PAGE
Issued By QA
Sign & Date:-
Below Right Upper Corner of the Page, On Non-text part of the Page, Stamp in
Stamp in Green Ink, Signed by Black Ink Green Ink, Signed by Black Ink Ball Point
Ball Point Pen Pen

Name
Signature
Date
ANNEXURE–VII
QUALITY ASSURANCE
MASTER/EXECUTED DOCUMENT DESTRUCTION RECORD
S. Document Title Document Document Date of Destruction Destruction Reason

No. No. Type Destruction Done By Checked By for
(Sign & Date) (Sign & Date) Destructi
on

Name
Signature
Date
TITLE : PROCEDURE FOR DOCUMENTATION AND DATA CONTROL
ANNEXURE–VIII
QUALITY ASSURANCE
LOG LOG BOOKS/REGISTER ISSUANCE & RETRIEVAL LOG
Department: Month: Year:
Issuance Retrieval
Log Book Number

Title of Document
Received by QA
Format Number
Sign & Date
No. of Copies
Retrieved By
Received By
Sign & Date

Sign & Date
Copy Issued
Retrieved
Issued By
Remarks
No. of
Date

Name
Signature
Date

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The definition of Good Documentation Practice (GDP) describes standards by which

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6.3 LIFE CYCLE & DESTRUCTION OF DOCUMENTS (MASTER AND EXECUTED):

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Document No. For site master file should be – SMH/QA/DOC/01

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11.0 REVISION HISTORY:

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CONTROLLED COPY OBSOLETE COPY

CONTROLLED COPY DISCONTINUED COPY

DISPLAY COPY REFERENCE COPY

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FORMAT No.: SOP/QA/017/F01-00 Page X of Y

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FORMAT No.: SOP/QA/017/F02-00 Page X of Y

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BOUND BOOK / REGISTER ISSUANCE SLIP

Format No.: Effective Date:

No. of Pages: From ______ To _______

FORMAT No.: SOP/QA/017/F03-00 Page X of Y

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S. No. Document / Format Document / Page No. of Copies Reason for

Prepared By Checked By Approved By Additional Pages Issued By QA

FORMAT No.: SOP/QA/017/F04-00 Page X of Y

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Unfilled Copy Destroyed

By Sign & Date

Sign & Date

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Middle of the Page, Stamp in Red Ink,

Left corner of the Page, Stamp in Red

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Middle of the Page, above header, Stamp in Violet

Middle of the Page, Stamp in Red Ink,

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FORMAT No.: SOP/QA/017/F07-01 Page X of Y

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S. Document Title Document Document Date of Destruction Destruction Reason

FORMAT No.: SOP/QA/017/F08-01 Page X of Y

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Log Book Number

Sign & Date

Sign & Date

FORMAT No.: SOP/QA/017/F09-0 Page X of Y

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