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

If you’d like to be regularly informed on the latest developments in Good Manufacturing Practices

 

>>> REGISTER for our free GMP Newsletter LOGFILE

Workshop
GMP Inspections in Europe: Proven Strategies on How to Prepare

>>> More information

TOP 5 GMP Downloads

1. GMP Audit Checklist
The GMP Audit Checklist works great for both sides - the auditor and the inspected company.

 

2. GDP Audit Checklist
More than 700 questions with reference to regulations for preparing and carrying out GDP audits.

 

3. Quality Agreement
Defines framework conditions and processes between contract givers and contract acceptors in order to meet mandatory quality criteria.

 

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

 

5. A Process Approach to Pharmaceutical Quality Systems
A Guide to ICH Q10 Compliance

 

>>> Click here to find 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.