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Description of the Standard Operation Procedures - GMP document management
Good manufacturing practice (GMP) regulations require that all documentation be issued, managed and controlled using a document management system.
This 11-page Standard Operating Procedure (SOP) describes the procedures for completing all GMP-relevant paper documentation pertaining to preparation, approval, control, amendment, withdrawal, distribution and archiving. This SOP will guide you through the process of setting up a new GMP document management system and help you to optimise an existing document management system.
Table of Content
1. Regulatory Basis, Reference Documents
4. Responsibilities and Accountabilities
4.1 Quality Unit: responsible for
4.2 Department Heads: responsible for
5.1 Preparation/Updation and Approval of Documents:
5.2 Distribution of Documents:
7. Document archival
8. Destruction of documents
Attachment 1 Archived GMP Document/Record Issue & Retrieval Record
Attachment 2 Distribution Record of GMP Document
Attachment 3 GMP Document/Record Destruction record