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GMP in Practice: 24 chapters written by internationally renowned industry experts.

 

GMP Regulations: 8 chapters with the most important GMP guidelines and regulations.

 

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TOP 5 GMP Downloads

1. GMP Fundamentals
A quick and comprehensive overview of the complex world of GMP.

 

2. GMP Audit Checklist
Great for both sides - the auditor and the inspected company.

 

3. GDP Audit Checklist
More than 700 questions with reference to regulations.

 

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A concise overview of the OOX process.

 

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Standard draft to adapt and extend.

 

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News about GMP/cGMP

2009-06-03

The U.S. Food and Drug Administration (FDA) today announced the formation of a task force to develop recommendations for enhancing the transparency of the agency’s operations and decision-making process.

 
2009-05-21

Endotoxin Testing and Sterility Testing at the end of shelf-life. Requirements and answers to questions of the EMEA Quality Working Party, Inspections section.

 
 
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