• gmp-verlag.de
  • GMP MANUAL Login
  • Shopping cart
Stay informed!

You’d like to be regularly informed on the latest developments in Good Manufacturing Practices?

 

Subscribe to our free GMP Newsletter LOGFILE!

>>> REGISTER NOW

GMP MANUAL

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

 

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

 

Image

>>> READ MORE

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.

 

4. Industry Guide to handle OOX Test Results
A concise overview of the OOX process.

 

5. GMP-Questionnaire: Contract manufacturing / Contract analysis
Standard draft to adapt and extend.

 

>>> More Downloads

News about GMP/cGMP

EU-GMP: Annex 14 in Operation

The revised Annex 14 of the EU GPM Guide is comming into operation on November 30, 2011.

 

Annex 14 "Manufacture of Medicinal Products Derived from Human Blood or Plasma" was published in May 2011 after an extensive revision.

The annex was revised due to the development of standards concerning quality and safety for the collection and testing of human blood and blood components for all uses, including the manufacture of medicinal products.

Outcome:

Make sure you are well prepared, when the revised annex 14 is comming into operation on November 30, 2011. The EC has published the annex online.

Source:

EC/ Annex 16

Comments
No comment has yet been written about this news.