GMP Document Management - GMP SOP
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
|SKU||GMP Document Management - GMP SOP|
What you will get:
Delivery item: Word Document
You will be able to enter your data into the Word document.
Please note: We do not deliver hard copies.
WonderfulGMP Document Management - GMP SOP onI have always been grateful for your documents. I have been a regular customer for more than a year and will continue using your products in my work.
- Creation and use of GMP equipment logbooks - Free GMP SOP
- Contract Manufacturer Solids - Contractor Quality Questionnaire - GMP Quality ContractRegular Price $240.00 Today $197.00+ 16% german VAT when applicable
- Returned Drug Products - GMP SOPRegular Price $100.00 Today $89.00+ 16% german VAT when applicable
- Deviations (Failure Investigations, Non-Conformance) - GMP SOPRegular Price $95.00 Today $79.00+ 16% german VAT when applicable