If you’d like to be regularly informed of the latest developments at Good Manufacturing Practices
1. Site Master File
A Sample for Download
according to PIC/S PE 008-4!
2. Checklist GMP-Inspections
650 questions typically asked during audits
3. Process Validation
official requirements, validation planning and procedure, ...
GMP Compliant Documentation
How to create, organize, review and archive GMP related documents in pharmaceutical industries
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This regulatory guideline works as a tool for facilitating co-operation between the GMP inspectorates of the Member States and a means of achieving harmonisation. The procedures within it provide the basis for national procedures that form part of the national GMP inspectorates’ quality systems.
In July 2010 documents connected with Good Distribution Practice (GDP) inspections started to be added to the Compilation.
Newly added in the CoCP are the following "Forms used by regulations":
Also newly added is the document "Procedure for Dealing with Serious GMP Non-Compliance Information Originating from Third Country Authorities or International Organisations".
If you are interested in more details please see the original document.
EMA: Compilation of Community Procedures on Inspections and Exchange of Information