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

If you’d like to be regularly informed of the latest developments at Good Manufacturing Practices

 

>>> REGISTER for our free GMP Newsletter LOGFILE

Image

TOP 5 GMP Downloads

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

 

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

 

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

 

4. Technical Agreement
and Delimination of Pharmaceutical Responsibilities.

 

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

 

Your benefits:

> no shipping costs
> no waiting period: if you choose payment by credit card you will receive an email with the download information immediately after payment.

 

>>> Click here to find more Downloads!

News about GMP/cGMP

2011-11-25

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.