• gmp-verlag.de
  • GMP MANUAL Login
  • Shopping cart
Stay informed!

If you’d like to be regularly informed on the latest developments in Good Manufacturing Practices


>>> REGISTER for our free GMP Newsletter LOGFILE

GMP Inspections in Europe: Proven Strategies on How to Prepare

>>> More information

TOP 5 GMP Downloads

1. GMP Audit Checklist
The GMP Audit Checklist works great for both sides - the auditor and the inspected company.


2. GDP Audit Checklist
More than 700 questions with reference to regulations for preparing and carrying out GDP audits.


3. Quality Agreement
Defines framework conditions and processes between contract givers and contract acceptors in order to meet mandatory quality criteria.


4. Creating a Master Plan for Drug Warehousing, Transportation and Distribution
Guide to preparing a company for compliance with Good Distribution Practice (GDP).


5. A Process Approach to Pharmaceutical Quality Systems
A Guide to ICH Q10 Compliance


>>> Click here to find 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.