This procedure is a prerequisite to your quality management system and to meeting regulatory compliance. Takes you through management and control of GMP documentation. A well proven SOP.


What is this document about?

  • This procedure is one of the core concepts of a Quality Management System and is one of the first and major system to be established in a GMP facility.
  • The purpose of this procedure is to define the requirements for proper control of GMP related documentation that supports the research, development, manufacture, packaging, testing, and distribution of products. This well proven procedure has been successfully implemented in established GMP facility.

Related Regulatory references:

In one form or the other, most regulatory authorities put a lot of emphasis on the control and Good Practices of Documentation.

  • FDA Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Section VI. Documentation and Records – A procedure should be established……etc
  • ICH Good Manufacturing Practice Guide for API Q7, Section 6 Documentation and Records
  • PIC/S PE 009-8 (Part I) Guide to GMP for Medicinal Products Part 1, Chapter 4 Documentation: Good documentation constitutes an essential part of the quality assurance system.

What does procedure include?

  • Definitions of terms and regulatory requirements
  • Storage, backup and retrieval of documents
  • Off site storage management
  • Records retention and destruction
  • 41 prompts of the type of GMP documents that typically need to be controlled
  • 4 x associated forms to give you instant implementation of SOP
  • This Microsoft Word 2003 format template is a real-life proven practice

Who needs this procedure?

  • Quality assurance and Document Control for the management and control of documentation
  • All departments that generate GMP documentation


Documentation Document Control

Related Documents:

Q00-0001   Policy Statement – Quality Management System

Q04-0103   Good Documentation Practice


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