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Customers Opinion

Recommended by PDA (Parenteral Drug Association):

 

"... The GMP MANUAL occupies a spot in my bookcase and I often have the occasion to refer to it. If you are a professional in the field of GMP and regulatory compliance, you may find it should be in your bookcase too."

Bob Dana, Sen. VP Regulatory Affairs

 

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GMP Quality Assurance

GMP Compliant Documentation
How to create, organize, review and archive GMP related documents in pharmaceutical industries

 
 
Risk Management
established methods of risk analysis
incl. ICH Q9

 
 
Laboratory & Analytical Controls
This title deals with the main subjects in Laboratory and Analytical Controls. Apart from the describing content you will find many tables, examples, forms, which can be used in the daily practice.

 
 
 
 
ICH Q8, Q9, Q10
GMP Pocket Guide Volume 4

 
 
Risk-Based Compliance Handbook
This book covers all stages of the drug lifecycle from R&D, to the clinical phases, the launch and pharmacovigilance stages, and the discontinuation step.

 
 
Quality by Design
Putting Theory Into Practice

 
 
 
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