• 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!


The New USP <1231>
Water for Pharmaceutical Purposes

a detailed Overview


Award for the

GMP knowledge that convinces.


On 7 June 2016 Maas & Peither GMP Publishing has received a

SIPAward in the category
"Best New Success Story" and was awarded with the 3rd place.

The GMP MANUAL impressed the jury with "Save Drugs through Better GMP Understanding".


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


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




TOP 5 GMP Downloads

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


2. GDP Audit Checklist

More than 700 questions with reference to regulations.


3. How to design a Laboratory Data Management System
Practical strategies for designing and implementing an LDMS.

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


5. GMP Compliance Basics of Packaging Materials and Processes
Are you on top of the best practices you need to design and create your packaging correctly — every time?


>>> More Downloads

News about GMP/cGMP

FDA: New ICH Q4B Annexes 5, 8, 11 &12

FDA published recently the new ICH Q4B Annexes as Guidance for Industry.


The annexes 8, 11 & 12 of the ICH QB4 document "Evaluation and Recommendation of Pharmacopoeial Texts used in the ICH Regions" are not really new. They were already published by the ICH at its website.

With the US implementation  they were now published as Guidance for Industry at the FDA website

Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions

Source: FDA News websiteICH Quality Guidelines

No comment has yet been written about this news.