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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The annexes 8, 11 & 12 of the ICH QB4 document "Evaluation and Recommendation of Pharmacopoeial Texts used in the ICH Regions" are not really new. They were already published by the ICH at its website.
With the US implementation they were now published as Guidance for Industry at the FDA website
Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
Source: FDA News website & ICH Quality Guidelines