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Excerpts from the GMP MANUAL

Topic-related excerpts from the GMP MANUAL as eBooks or booklets:

GMP Audit Checklist
for Pharmaceutical and API Manufacturers

Checklist with more than 700 questions typically asked during GMP audits or inspections

 
 
GDP Audit Checklist
for the Storage and Transport of Pharmaceuticals

More than 700 questions with references to regulations for preparing and carrying out GDP audits

 
 
 
Microbiological Monitoring in Pharmaceutical Manufacturing
A Guide to Control Microbial Risks in Sterile and Aseptic Drug Manufacturing

NEW ++ NEW ++ NEW

 
 
The Process of Freeze-Drying
A Model to Implement and Run a Compliant Freeze Drying Process

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

 
 
Creating a Master Plan for Drug Warehousing, Transportation and Distribution
Guide to preparing a company for compliance with Good Distribution Practice (GDP)

NEW ++ NEW ++ NEW

 
 
Manufacturing Sterile Products to Meet EU and FDA Guidelines
This management report spells out how U.S. and EU manufacturers must handle sterile processing.

 
 
 
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