• 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 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".

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.




TOP 5 GMP Downloads

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

2. GDP Audit Checklist
More than 700 questions with reference to regulations.

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

4. Industry Guide to handle OOX Test Results
Every single step of the OOX process.

5. The New USP <1231>: Water for Pharmaceutical Purposes
A compact overview of the contents of the new version of USP <1231>.

>>> More Downloads

News about GMP/cGMP


British MHRA Published Trends on GMP Deficiency Data

The GMDP Inspectorate of the British MHRA (Medicines & Healthcare products Regulatory Agency) has published its yearly report on inspection deficiency findings. This time the method of gathering the data has been improved, thus introducing new data trending.


This will allow industries to identify:

  • The severities and frequencies by the EU GMP references
  • The overall number of deficiencies by categories: Critical, Major, Other
  • The high impact vs high frequency issues

According to the MHRA, the purpose for publishing the inspection deficiency data was to allow industries to perform their own assessment against the deficiency findings as part of self-inspection and continuous improvement.

242 UK inspections and 82 overseas inspections were conducted in 2016 (324 inspections in total)

Here are the Top 10 most cited deficiency groups 2016:

Ranking Groups Critical Major Others
1 Quality System 38 449 772
2 Sterility Assurance 34 190 162
3 Production 20 191 543
4 Complaints and Recall 11 80 110
5 Qualification/Validation 10 123 232
6 Premises & Equipment 9 113 464
7 Computerised Systems 9 44 120
8 Personnel 8 42 150
9 Documentation 2 166 646
10 Quality Control 2 42 192

If you are interested in reading the full report, please click here.

No comment has yet been written about this news.
Literature recommendation
GMP Compliance Adviser
Single User Licence (yearly subscription)