• 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

EMA FAQ on GMP Topics

While EMA (EMEA) welcomes questions on its activities and the regulatory framework within which it operates, specific questions on the interpretation of GMP requirements should be addressed, ideally by the Qualified Person, directly to the relevant supervisory authority of the Member State in which the manufacturing authorisation holder is located. Manufacturers based in third countries should make contact through the Qualified Person of the authorised importer.


From time to time EMA (EMEA) publishes the answers to frequently asked questions following discussion and agreement of the GMP/GDP Inspectors Working Group and they are published on this page.

There are four topics of questions and answers, covering several subitems:

  • EU GMP Guide Part I Basic Requirements for Medicinal Products
    - Chapter 5 Qualification of suppliers
  • EU GMP Guide Part II Basic Requirements for Active Substances used as Starting Materials
    - GMP compliance for Active Substances
    - GMP compliance for Active Substances in IMPs
  • EU GMP Guide Annexes - Supplementary Requirements
    - Annex 1 Manufacture of Sterile Medicinal Products
    - Annex 8 Sampling of Starting and Packaging Materials
    - Annex 13
  • Miscellaneous 
    - General GMP
    - GMP Certificates

Check the information provided by EMA (EMEA), because it gives you a review on cGMP-developements and offers you first-hand information from the inspectors point-of-view.



No comment has yet been written about this news.