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Documents and Data Control in Pharmaceuticals

Documents and Data Control is a function or department which keeps track of all
documentation, specifications, and processes. The purpose is to ensure that everyone uses the
correct and current document processes and specifications.

SOP for Documents and Data Control

1.0 Objective
To lay down a procedure for control of documents and documented data.

2.0 Scope
This SOP is applicable for the control/management of documents and documented data
at the pharmaceutical drug manufacturing plant.

3.0 Responsibility
 Authorized QA person shall be responsible for issuance and retrieval of the SOP’s,
formats, Protocols, etc.
 All HODs shall be responsible to follow this SOP for maintaining control on all
documents and documented data or records.

4.0 Procedure for Documents and Data Management

 Documents and Data Control:
o Documents and Data Control is a function or department which keeps track of
all documentation, specifications, and processes.
o The purpose is to ensure that everyone uses the correct and current document
processes and specifications.
 Control of Documents:
o After preparation, the original signed documents shall be submitted on A4 size bond
paper to the QA Department to control & storage.

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 o The originally signed copies of all documents shall be stamped as ‘MASTER COPY’
stamp using Red ink as per the below image, on the top right corner of each & every
page. It is referred to as MASTER COPY.
o For the preparation of controlled copies of the master copy, authorized QA
personnel shall arrange photocopies of the master copy on plain A4 size paper, using
one side of the plain paper.
o Each page of the photocopy of the master copy shall be stamped as ‘CONTROLLED
COPY’ using blue ink, on the top right corner below the master stamp of each page
(rectangular space) with Sign/Date of the authorized QA person on each page.
o A record of controlled copies shall be maintained.
o These copies shall be used for filling data or as reference documents.
o While issuing an uncontrolled copy of the documents and data, the photocopy of the
master copy shall be stamped as ‘UNCONTROLLED COPY’ using blue ink, on the
right-hand bottom corner of each page with the sign and date of the authorized QA
person.
o ‘UNCONTROLLED COPY’ shall not be required to be retrieved.
o The Master copy stamp, controlled copy stamp, obsolete copy stamp, uncontrolled
copy stamp, and all other related stamps shall be under the control of the QA
documentation cell/Authorized QA person.
o Only QA shall retain a computer copy of SOPs with Annexure(s) of all departments
and other master documents.
o QA Department shall store the computer copies (SOP) in Department-wise folders.
o In these folders create the folder named ‘Master SOPs’. The ‘Master SOPs’ folder
shall store respective SOPs and their annexure along with the SOP index.
o Only the current version of the SOP shall be maintained in the soft copy folder.
o Data backup shall be taken at least once in a six month by IT department.
o The computer system in which all documents preserved in soft copy form shall
be password protected and password shall be available to the user, section Head,
and QA Head only.
 Obsolete Documents and Data:
o Obsolete documents are those which are no longer required, replaced.
o These documents may be identified as part of the review process and shall be
removed from the master documents and appropriately archived to prevent
unintended use.
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 o Archived documents must be retained and accessible for system evaluation and legal
purposes.
o The “OBSOLETE COPY” as per the below image of the old version of a master copy
shall be stamped with red ink on the right-hand bottom corner of each & every page
on the text with the sign and date of the authorized QA person.
 Requisition/Issuance/Retrieval of Logbooks (Documents and Data Control):
o The user department shall send the approved requisition, before the
implementation of logbook/formats/protocols to the QA Department as
per Annexure-I at least one week before.
o The authorized QA personnel shall issue the logbook as per approved requisition and
issuance & retrieval record shall be maintained on Annexure-I.
o Annexure-II shall be affixed on the first page of the equipment/instrument logbook.
o Whenever required opening balance or other entry shall be a transcript from the old
logbook and reference of the same logbook shall be written in the current logbook
for traceability purposes.
o All filled logbook shall be retrieved at the end of the year except those logbooks
which are used to maintain the stock.
o Logbooks that are used to maintain the stock same shall be continued till a change in
the format or completion of the logbook.
o If there requirement for a second logbook in the same calendar year same shall be
issued after retrieval of the previous logbook and the record shall be maintained
in Annexure-I.
 Requisition/Issuance/Retrieval of Formats (Documents and Data Control):
o The user department shall send the approved requisition as per Annexure-I, one
week before the end of the month to the QA Department.
o The pdf file shall be converted from the word format copy of the Annexure(s) and
the same shall be kept in the QA custody.
o For issuance of format, the authorized QA person shall take the printout of the
required annexure from the computer and put the stamp as ‘CONTROLLED COPY’
using blue ink, on the top right corner of each page (rectangular space, if provided).
o The authorized QA personnel shall sign and date in the stamp and the same shall be
issued as per approved requisition and the issuance record shall be maintained
on Annexure-I.
o If there is no retrieval, NA shall be written under the retrieval and remark column.

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 o If issued formats are retrieved same shall be recorded in Annexure-I and shall be
destroyed by shredding and shall be updated under remark column.
 Requisition/Issuance/Retrieval of Protocols (Documents and Data Control):
o The user department shall send the approved requisition on Annexure-I, as when
required, to QA Department.
o For issuance of protocols, the authorized QA person shall take a photocopy of the
respective protocols and put the stamp as ‘CONTROLLED COPY’ using blue ink, on
the top right corner of each page (rectangular space, if provided).
o The authorized QA personnel put sign/Date as space provided on respective
annexure and issuance and retrieval record shall be maintained as per
the Annexure-I.
 Requisition, Distribution, and Retrieval of the Documents and Data:
o User Department shall provide the approved request to QA for executed documents
(Such as Manual, Qualification documents, Executed Batch records, Executed QC
data, etc.) whenever required as per Annexure-III.
o Each Department shall submit original documents to QA, the reference documents
(like machine manuals, etc.), and literature cross-referred in preparing the
documents like SOPs, protocols, etc. The controlled copy of the master documents
shall be issued to the user department for reference purposes.
o The issued and retrieval record shall be maintained as per Annexure-IV.
o Additional pages of BMR/BPR shall be issued after receipt of approved requisition
from production as per Annexure-V.
o SOPs may require the annexure which is to be updated frequently, e.g., list of
equipment, list of approved vendors as per SOP.
o In this case, the annexure shall be updated and controlled, and distributed as per
this SOP. While revising such annexure, it is not required to revise the whole SOP
unless the objective and scope of the SOP gets changed.
 Review Revision of the Documents and Data:
o The SOPs shall be reviewed/revised follow the direction of SOP Management and all
other master documents shall be reviewed within + 30 days of the ‘Review Date’
assigned on the concerned document.
o The documents on which reviewed dates are not defined like MFR, specification,
TDS, protocols shall be reviewed within 2 Years + 30 days and if any discrepancy
observed shall be handled as per Annexure-VIII.

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 o After the approval of Annexure-VIII, the same shall be rectified.
 Periodic Review of logbook:
All the logbooks of equipment/machines logbooks, etc., shall be reviewed monthly and
records shall be maintained on Annexure-II.
 Handling of Records
o Each department shall be responsible for filling in all the records relevant to the
approved written procedures.
o The documented data or records shall be forwarded to the QA Department at
appropriate intervals.
 Issuance of Documents to Inspection Team/Customer
o For Onsite Inspection Team:
 Request for any record by the inspection team shall be communicated by the
cross-function audit team to the QA back-up team.
 The QA back-up team members shall retrieve the correct record, review for
adequacy, completeness and relevance, before passing it over to the cross-
function audit team.
 Original documents/controlled documents shall be provided to the inspection
team whichever applicable.
 The cross-function audit team members attending to the inspection team shall
ensure that the original records/documents are returned back to the respective
departments.
o For Offsite Inspection Team/Customer:
 Photocopies of records/documents for the inspection team shall be stamped
with “UNCONTROLLED COPY” and signed with the date by QA.
 A list of photocopies of all such records/documents handed over to the
inspection team shall be available with QA for future reference so as to avoid
contradictions/confusion.
 No original records/documents shall be given as evidence to the offsite
Inspection team for attachments to their audit reports.
 Handling of External Documents and Data:
o If any external origin document like;
 Pharmacopoeial document,
 Reference books or any type of technical document

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 o Received at the plant shall be stamped by QA authorized person as per below on the
first page and the last page of the document after review and verification of
documents.
 Review and Approval of Calibration Certificates, Validation Certificate, and Reports:
o All the calibration data of equipment/instrument like:
 Data of calibration for thermometers, gauges, PLCs, motors, pumps,
 Validation certificate, and reports, etc., received from outside party shall be
received and reviewed by the Engineering Department.
o Kept/maintained by the QA departments and this certificate shall be stamped with
sign and date.
o Wherever required, a reference copy of the Master calibration certificate shall be
issued to the user function as per their requirement.
o The analytical reports shall be received, reviewed and these reports shall be
stamped in suitable space on each and every page of calibration certificate with sign
and date by authorized QC person and record maintained in the relevant
documents.
 Issuance of Records for Reference
In case supporting documents/records attached with any master documents, change
control deviation, CAPA, etc., that time photocopy of the master documents stamps
as “REFERENCE COPY” using red ink on the right-hand bottom corner of each page
with sign and date of authorized QA person.

REFERENCE COPY
Sign/Date: …..……….

 Storage and Destruction of Documents and Records/Data:

o All the documents/data must be kept under lock and key in the control of Quality
Assurance and record shall be maintained.
o Authorized QA Person shall prepare a list of records in duplicate and paste one
copy on the box & the second in the file which is placed in the record room.
o Place the box on the rack and write the rack no. on the box and on the second
copy that is filed.

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o The storage arrangements must make reasonable provisions to prevent loss of or
damage to the documents.
o The risk factors to be considered when assessing the storage arrangements
include fire, water, environmental conditions, insects, rodents, theft, accidental
destruction, incorrect filing, easy retrieval, and failure to return from the issue
Department.
o The retention period of the documents/records shall be handled as per Annexure-
VII.
o For Regulatory Market,
The specific requirements apply to batch documentation which must be kept for
one year after the expiry of the batch to which it relates or at least five years after
certification of the batch by the Qualified Person, whichever is the longer.
o For investigational medicinal products,
The batch documentation must be kept for at least five years after the completion
of formal discontinuation of the last clinical trial in which the batch was used.
o Destroy the documents by cutting them into small pieces in the presence of Head
QA /Designee.
o The record of destruction shall be maintained by QA as per the Annexure-VI.

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5.0 Annexure: Documents and Data Control
Annexure-I: Requisition/Issuance/Retrieval for Logbooks/Formats/Protocols

Department: ………………… Date…………….

Issuance Record Retrieval Record
Number of Page No.
copies of Issued Received No. of Retrieval
Format Eq. ID
No. Title Logbooks/ By (QA) By copies By (QA) Remark
No. No./Area From To
Formats/ Sign/Date Sign/Date Retrieved Sign/Date
Protocols

Requested By (Sign. & Date)

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 Annexure-II: Review Record of Equipment/Instrument Logbook

Monthly Review: Shall be reviewed in first week of next month.

Sr. Checked By Reviewed By (QA)

Month/Year (User Department) Remark
No. Sign/Date
Sign/Date

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 Annexure-III: Document Issuance and Retrieval Form

Department Date
Name of the document
required

Document No. Revision No.

Number of Copies/Pages/
Required

Details of Document
(Like B. No./Protocol No.
/Report No. whichever is
applicable)

Reason for Requisition

Initiated By (User) Sign. & Date Checked By (User) Sign. & Date
Request Approved/Rejected
Head QA Sign & Date
By QA (Comments if any)
Document Received (User) By Name Sign Date
Document Retrieval Details
Document Submitted (User) By Name Sign Date

Document Retrieved By QA Name Sign Date

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 Annexure-IV: Distribution and Retrieval Record of Documents

Name of Document Revision Effective No. of issued Received Name of

S. No. Department S. No.
Document No. No. Date Copies By By/ON Document

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 Annexure-V: Format for Issuance of Additional Pages of BMR/BPR

Department Date
 Batch Manufacturing Record
Type of Document  Batch Packaging Record

Product Name

Document No.

Revision No.

Batch No. B. Size Mfg. Date Exp. Date

Page No. No. of Copies Reason for Requirement

Initiated By Approved By HOD

Sign & Date Sign & Date
Request Approved/Rejected By Head QA
QA (Comments if any) Sign & Date
Request Received By
Sign & Date
Document Issued By
Sign & Date
Received By (Production)
Sign & Date

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 Annexure-VI: Document Destruction Record

Destroyed
Document Batch No./A.R. By
No. Document Title Remarks
No. No.
Sign/Date

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 Annexure-VII – List of Completed Document Retention Period

PRODUCTION
Name of Document Retention Period
Batch Production Record(s) of Exhibit Batch and Process Validation Perpetual
Batch Production record 5 Years
Equipment Logs (usage and cleaning) 5 Years
Equipment/Instrument Calibration Records 5 Years
Record for inspection of tools and punches. 5 Years
Area Cleaning Records 5 Years

QUALITY CONTROL
Name of Document Retention Period
Finished Product and Stability Record of analysis for Exhibit batch(es) Perpetual
Raw material/packaging material Record of analysis for materials (AR
Perpetual
No.) used in Exhibit batch(es)
Analytical record(s) related to cleaning validation. Perpetual
Analytical Method Transfer qualification report(s) and related
Perpetual
register(s).
Raw Material and Packaging Material records 5 Years
Reference standard/Working standard records 5 Years
Volumetric solutions preparation and standardization record 5 Years
Instrument/equipment usage Logs 5 Years
Control sample records for Raw materials 5 Years
Calibration records of instruments/Equipment and Glassware 5 Years
Vendor samples analysis data 5 Years
Microbiology records 5 Years

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Analytical Method Validation Protocol(s) and Report(s) Perpetual
Analytical Method Development Report Perpetual
Registers and files related to analytical Method validation and
5 Years
development
Sample inward register 5 Years
Environmental monitoring records 5 Years
Master Validation Plan Perpetual
Equipment Qualification Protocol Perpetual
HVAC Validation Perpetual
Water system validation protocol Perpetual
Compressed air validation protocol Perpetual
Cleaning validation protocol Perpetual
Process validation protocols and reports Perpetual

QUALITY ASSURANCE
Name of Document Retention Period
Stability Protocols of Validation/commercial batch Perpetual
Obsolete and superseded master documents Perpetual
Vendor Qualification files Perpetual
Layout files Perpetual
Stability Protocol Perpetual
Master document Issuance Records 5 Years
Issue Records of other than master documents 5 Years
Control Sample Record of Finished product Expiry + 1 Year
Change control log and related records 5 Years
Self-Inspection Record 5 Years
Out Of Specifications investigation records 5 Years
Market complaint record Perpetual
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Annual product quality review report Perpetual
Product recalls documents Perpetual
Deviations log, incident, and related reports 5 Years
5 Years from the date of
Training records resignation/retirement
of the employee
Hold Time Study records Perpetual
5 Years from the date of
Employee Specimen Signature Record resignation/retirement
of the employee
Product Development documents Perpetual
Stability Protocol for Exhibit batch Perpetual
Technology Transfer documents Perpetual

REGULATORY AFFAIRS
Name of Document Retention Period
Abbreviated New Drug Application Perpetual
Annual reports, supplements and amendments Perpetual
Site Master File Perpetual

ENGINEERING
Name of Document Retention Period
Equipment/Instruments calibration records 5 Years
Filter cleaning logbook 5 Years
Equipment usage and Maintenance log 5 Years
Preventive maintenance/Breakdown Maintenance records 5 Years

WAREHOUSE
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Name of Document Retention Period
Material inward register 5 Years
Equipment usage and cleaning logbooks 5 Years
Calibration record of equipment/Instruments 5 Years
Stock cards 5 Years
Return drug product documents 5 Years
Environmental monitoring records 5 Years

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 Annexure-VIII: Review of Documents

Document Name:
Document Number: Revision No.
Reason for Review:
Review Details:

Sr. No. Observations Proposed Action

Reviewed By (Sign/Date)
Remarks/Comments: ………………..……………………………………………………………………

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 Annexure-IX: Logbook for Issuance of Perforated Formats

Page Used for Issued by

Title of Format
Date Serial Product/ Batch No./ Remarks
Format Number Other Sign/Date
No. Material AR No.

6.0 Reference
1. The Rules Governing Medicinal Products in the European Union: Volume 4, EUGMP
Medicinal Products for Human and Veterinary Use. Chapter 4: Documentation.
2. Drugs and Cosmetic Act 1940 Schedule M.

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