• 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

WHO Report: Inspections of API Manufacturers

Recently the WHO (World Health Organization) issued the first "Pharmaceuticals Newsletter" in 2011. It contains an interesting Report on WHO Inspection Activites of API (Active Pharmaceutical Ingredients) Manufacturers.


API manufacturing site inspections were started in 2003. An inspection team normally consists of a WHO inspector based in Geneva and a co-inspector appointed by the WHO from a Pharmaceutical Inspection Cooperation Scheme (PIC/S) member inspectorate. An inspector (or inspectors) from the National Drug Regulatory Authority of the country, in which the manufacturing site is located is invited to participate as an observer.


Out of 126 API sites participating in PQ activities, 49 were accepted based on approval by PICS inspectorates and/or ICH countries, while 31 were inspected by WHO inspectors. Six of the inspected sites were found to operate at an unacceptable level of compliance with WHO GMP.

Key Observations of API inspections

Deficiencies observed during inspections of API sites have been mainly in materials management, documentation, cleaning and cross-contamination.


You can download the WHO "Pharmaceuticals Newsletter", Issue 1/ 2011. You find the complete report at page 12 et seqq.


WHO/ Newsletter

No comment has yet been written about this news.