• gmp-verlag.de
  • GMP Compliance Adviser 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!


GMP Compliance Adviser

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


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




Award for the
GMP Compliance Adviser

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 (now: GMP Compliance Adviser) impressed the jury with "Safe Drugs through Better GMP Understanding".

TOP 5 GMP Downloads

1. Questionnaire for preparing GMP-inspections
More than 650 typical questions related to audits and inspections.

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

3. GDP Audit Questionnaire
More than 700 questions with reference to regulations.

4. A Pharma Guide to Cleaning Validation
How to meet Agency Expectations and Establish Accepted Limits.

5. Data Integrity in the EU
Requirements for Quality Management Systems.

>>> More Downloads

News about GMP/cGMP


ICH: Additional Training Modules to ICH Q3D

As previously announced, the International Council on Harmonization (ICH) has now published the additional two training modules to ICH Q3D Elemental Impurities on its website. The modules 8 (case studies) and 9 (FAQs) are part of a comprehensive training programme prepared by the ICH Implementation Working Group (our news of March 2016).


The Modules comprise:

  • Module 8-1a: Case Study 1A Solid Oral Drug Product (14 pages)
  • Module 8-1b: Case Study 1B Solid Oral Drug Product (9 pages)
  • Module 8-2: Case Study 2 for Parenteral Drug Product (14 pages)
  • Module 8-3: Case Study 3 for Parenteral Recombinant Protein Drug Product (17 pages)
  • Module 9: Consolidated FAQs  (4 pages)

The Q3D Training Modules 8-9 can now be found on the ICH website and are available in form of a zip file.


ICH: Newsroom

No comment has yet been written about this news.
Literature recommendation
Technical Solutions for Personnel Protection in Solid Drug Manufacturing
GMP Compliance Adviser
Single User Licence (monthly subscription)