Never ever a 483?
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but we know that the GMP MANUAL includes all
procedures and processes you need to be
GMP compliant.
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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
PIC/S: Revised Site Master File
Aim of the revision were the simplification of the document and the implementation of requirements in relation with quality risk management.
Outcome:
The revised document enters in force on January 01, 2011. You can download the document here.
Links:
PIC/S/ Announcement
PIC/S Site Master File