SOP For Documentation Control Procedure

SOP For Documentation Control Procedure

Standard Operating Procedures for Approval  & Control documentation( SOP For Documentation & Data Control)  in Pharmaceutical Industry.

 Objective :-

The purpose of this SOP to lay out the procedure for the preparation, Review, Approval, Distribution, Revision , Retrieval, Archival & Destruction of the Master/Control Documents existing in manufacturing Unit & insure the integrity of the throughout the retention Period.

Scope :-

The Scope of this SOP to lay out the procedure for the preparation, Review, Approval, Distribution, Revision , Retrieval, Archival & Destruction of the Documents generated with in the Manufacturing Unit.

Responsibility :-

QA Officer/Executive Shall be responsible for Review, Approval, Distribution, Revision, Retrieval, Archival and Destruction of the Master Documents.

Head QA shall be responsible for approving the documents and verifying the changes in the documents and to ensure that the documents are maintained, distributed, retrieved, archived and destroyed as per the SOP.

Procedure :-

General Requirements:

The Master documents are divided in categories as mentioned below (but not limited to):

  • Standard operating procedure
  • Formats / log books
  • MFR, BMR & BPR
  • Method of Analysis / Standard test procedure/Specification.
  • Approved Vendor List
  • Site Master File
  • Validation Master Plan
  • Layouts
  • Protocol

Control of Documents :

  • Master Documents :-  Approved Documents shall be stamped as “Mater Copy” in Red Colour at top Right Corner on each page.
  • Controlled Documents :- Copy of  Mastered Documents shall be stamped as “Controlled Copy” in Green Colour at bottom right corner on each page before distribution in respective departments.
  • Uncontrolled Copy: Shall available in red ink. This stamp used for authorizing the ‘UNCONTROLLED COPY’ from master copies/control copies of filled documents and distributed to Regulatory agencies, customers / others (if necessary).
  • Obsolete Copy: Shall available in red ink with. This stamp used for authorizing the ‘OBSOLETE’ of old version of master documents put on the central middle of the pages and shall retained with QA department.
  • Display Copy: Shall available in blue ink. This stamp used for ‘DISPLAY COPY’ of documents from master copies of documents and distributed to user department.

Issuance of Documents :

  • Issuance shall be done by QA Officer/Executive. only Controlled Copy & Display Copy  shall be issued in Manufacturing plant.
  • Issuance of Documents record shall be maintain by QA department with date.

Retrieval and Destruction of Documents:

  • Retrieval of SOP/Format/BMR/BPR old version of these documents shall be Retrieve from all departments and new version shall be distributed to them.
  • Retrieval entry shall be done in Distribution/Issuance record.
  • Without retrieval of old version new version shall not be distributed.
  • After completion of retention period of respective documents shall be distrusted by shredding or incineration.
  • Destruction note shall be retain in QA.

Electronic Data & its Control:

QA shall maintain soft copy of Quality System Documents. Electronic Record shall be regularly backed up.

Annexure :-

  • Requisition for Issuance of Formats
  • Log book / register Label

-Requisition for issuance of BMR / BPR

  • Format Issuance record

-Log book / Register Issuance Record

-Document Control Record

  • SOP Distribution record

-BMR / BPR issuance record

 

REFERENCES:                                          

Guide to Good Manufacturing Practice For Medicinal Products – PE 009-10 (Part I), Chapter 4 –PIC’s, January 2013

 

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