• 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


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


On April 20, 2010 EMA published new information on Heparin Monographs according to the European Pharmacopoeia.


FDAs Task Force concering the Transparency Initiative is collecting information on how to improve FDA's transparency to regulated industry. They held three listening sesions with members of regulated industry during January 2010.


On April 1, 2010 European Pharmacopoeia Commission published information concerning a survey to possible changes regarding Water for Injection.

Currently, the European Pharmacopoeia only allows distillation for the production of Water for Injection (WFI). Renewed discussions have taken place at the end of 2009 amongst regulators in Europe on the suitability of using Reverse Osmosis (RO) to produce WFI. Concerns from regulators regarding the use of RO for the production of WFI had previously been expressed in a reflection paper issued by the Joint CHMP/CVMP Quality Working Party in early 2008.


EFPIA (European Federation of Pharmaceutical Industry and Associations) published the results of their product verification system pilot project on April 12, 2010. The pilot successfully demonstrated a product verification system at the point of drug-dispense of a swedish pharmacy chain. The system is based on a 2-D data matrix code.


On April 7, 2010 CDERs Division of Drug Information (DDI) published a Drug Information Update concerning the changes to the Heparin Sodium USP Monograph.


On 12 April 2010 we have relocated the Maas & Peither's German headquaters to a new address.


On April 2, 2010 FDA published the Annexes 7 "Dissolution Test General Chapter" and 9 "Tablet Friability General Chapter" to the Guidance for Industry "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions"

Page 39/53    35   36   37   38   39   40   41   42   43   44