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GMP Regulations

GMP for APIs
GMP Pocket Guide Volume 1
ICH Q7 combined with APIC/Cefic "How to do" Document

The ICH Q7 is the most important GMP guideline for active pharmaceutical ingredients manufacturers worldwide.

 
 
Computer Validation
GMP Pocket Guide Volume 2
- 21 CFR Part 11 Electronic Records, Electronic Signature
- PIC/S PI 011 Good Practices for Computerised Systems in Regulated ”GxP“ Environments
- EU-GMP-Guideline Annex 11 Computerised Systems

 
 
ICH Q8, Q9, Q10
GMP Pocket Guide Volume 4
ICH Q8 – ICH Q9 – ICH Q10

The ICH guidelines Q8, Q9 and Q10 represent the current thinking on the development of quality systems across the lifecycle of a product.

 
 
GMP In Practice
Regulatory Expectations for the Pharmaceutical Industry

 
 
 
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