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

 

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More than 700 questions with reference to regulations.

 

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Practical strategies for designing and implementing an LDMS.


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News about GMP/cGMP

2009-06-30

The following questions were asked:

 
2009-06-29

EMEA published June 29, 2009, four annexes to the ICH Q4B "Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions".

 
2009-06-29

FDA already publised this document on its website. Now EMEA also adopted this helpful document.

EMEA´s Questions & Answers to ICH Q8, Q9, Q10

 
2009-06-26

FDA published on June 26, 2009 the Guidance for Industry: Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices

 
2009-06-25

For those which were interested and were unable to attend the public meeting of the Transparency Task Force - the FDA has made the meeting viewable via webcast.

 
2009-06-22

RAPS (Regulatory Affairs Professionals Society), Rockville, MD, is the new Sales Partner of Maas & Peither America, Inc.

 
2009-06-22

European Medicines Agency launches public consultation on new transparency policy.

 
2009-06-08

EDQM recently published Supplement 6.6. Get a quick overview of the contents with the table of contents.

 
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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