Document Control

 1.0 OBJECTIVE

To lay down a procedure for Document Control.

2.0 SCOPE

This procedure is applicable to all documents in departments present in the XXX, Company.

3.0 RESPONSIBILITY

All department Heads 

 4.0  PROCEDURE 

4.1 The list of master Documents and their preparation and control are given in the following table.

4.2 Preparation, Approval And Authorization 

4.2.1 SOPs, Specifications & Test Procedures, Master Formula Records, BMRS, Site Master File, Master Validation plan, Qualification Documents

4.2.1.1 A draft document shall be written by Executive of the respective department.

4.2.1.2 The author shall submit the draft document to the Quality Assurance after the review by respective department Head. The Quality Assurance shall affix the “DRAFT COPY” stamp and attach Document Control Form as given Annexure-1 for review Comments and issue to the user department for checking its accuracy. For SOPs the SOP Review Form Shall attached as per Annexure- 4 of SOP.

4.2.1.3 The user shall evaluate/validate the procedure for accuracy and shall submit their comments after consultation with Head of the respective department to the Head-QA through Aneexure-1. For SOPs use Annexure- 4 of SOP.

4.2.1.4 The Head-QA shall be responsible for the final acceptance or rejection of the document based on the comments of author department and other departments.

4.2.1.5 In case of rejection of the document, the same procedure of preparation of documents shall be followed as mentioned above.

4.2.1.6 In case of acceptance of the documents by Head-QA based on Authors comments the Quality Assurance shall proceed further for approval of documents.

4.2.1.7  Validation Protocols

4.2.1.7.1 A draft protocol shall be prepared by author department.

4.2.1.7.2 The author shall submit the draft document to the Quality Assurance. The Quality Assurance shall affix the “DRAFT COPY” stamp and attach the A4 white sheet.

4.2.1.7.3 Quality Assurance shall forward the Draft to Validation review team along with Document Review Form as given in the Annexure-1.

4.2.1.7.4 The Validation review team shall submit the draft protocol along with comments to the author.

4.2.1.7.5 A separate review sheet for comments shall be submitted in case of any modifications in the procedure. This will be further submitted to Head-QA for further Authorization. The protocol shall be approved by Quality Assurance after modifications. The same shall be issued to Execution team for execution.

4.2.2 Distribution and Control of Documents

4.2.2.1 SOPs, Specifications & Test Procedures, Master Formula Records, BMRS, Site Master File, Master Validation Plan, Qualification Documents.

4.2.2.1.1 All approved and authorized documents having original signature shall be forwarded to Quality Assurance. The original copy shall be stamped “MASTER COPY” in Red colour on Top left corner.       

4.2.2.1.2 The Quality Assurance shall take photocopy of the “MASTER COPY” and stamp as “CONTROLLED  COPY” in Green colour on the bottom left corner.

4.2.2.1.3 The SOPs shall be distributed as per SOP. Other documents shall be distributed as per Annexure-2.

4.2.2.1.4 The distribution list shall be attached finally with the Master Copy and kept in the document room of Quality Assurance Department.

4.2.2.2  Validation Protocols

4.2.2.2.1  All approved and authorized protocols having original signature shall be forwarded to Quality Assurance. The original copy shall be stamped “MASTER COPY” in Red colour on top left corner.

4.2.2.2.2 These protocols shall be sent to the concerned department for execution.  

4.2.2.2.3 The protocols shall be sent to the QC for storage.

4.2.3  Revision of Documents

4.2.3.1  The documents shall only be revised if there is any change in operation, process, equipment, etc. The revision should follow the Change Control Procedure as per SOP.

4.2.3.2 After approval of the revised document, the old documents must be returned to Quality Assurance. The Quality Assurance shall ensure reconciliation and destroy the copies received, and record the details of destruction in the document distribution list (4.2.3.1.3).

4.2.3.3 The  “MASTER COPY” maintained in the Quality Assurance Department shall be stamped “OBSOLETE COPY” in black colour center of the paper and stored in Quality Assurance.

4.2.3.4 The revised documents shall go through once again the same procedure of approval, authorization and distribution as mentioned earlier.

4.2.3.5 Individual Department Head shall maintain the mentioned documents relevant to their areas and shall prepare a document master index and maintain the updated versions of the same. The updating shall be reflected in the Document master index at Quality Assurance.

4.2.4 Any revision / amendments applicable to Pharmacopoeias / guidelines shall be reviewed    by Head-QA & Head-QC for applicability. Necessary information shall be communicated to all concerned.

5.0 ABBREVIATIONS

5.1 QC-Quality Control

5.2 QA-Quality Assurance

5.3 SOP-Standard Operating Procedure

6.0 ANNEXURE

6.1  Annexure-1: Document Review Form

6.2  Annexure-2: Document issuance, Retrieval and Destruction Record