Never ever a 483?
We can not promise that you will never get a 483
but we know that the GMP MANUAL includes all
procedures and processes you need to be
GMP compliant.
Stay informed!
If you’d like to be regularly informed of the latest developments at Good Manufacturing Practices
GMP Subject Downloads
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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News about GMP/cGMP
New Part III EU GMP published (EC)
The EC adopted the Rules for establishing a Site Master File developed by the PIC/S.
The EC's notes are intended to provide guidance on the recommended content of a Site Master File. A requirement for a Site Master File is is referred to in Chapter 4 of the GMP Guide.
Outcome:
You can download the new Part III "GMP related Documents" here. This document will be part of the next update of the GMP MANUAL (May 2011).