• 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


EMA: Public Consultation on GMP Non-compliance Statement

On 3 April 2018, the EMA has published a 4-page public consultation document concerning the European Union template for GMP non-compliant statement. The GMP/GDP Inspectors Working Group is currently discussing possible actions required if inspections conclude with serious GMP non-compliance when at the same time this conclusion would block the availability of life-saving medicines. “What happens when?” is the question that EMA is now putting up for public discussion.


So far, in such cases, a statement of non-compliance is the outcome of the risk-assessment of GMP-compliance of an inspected site. Following the principles of ICH Q9, the concerned member states subsequently have to decide how to manage the risk (recall, prohibition of supply, suspension of MIA etc.). Where those actions might lead to shortages of critical medicines in a particular member state of the European Union, the competent authority of that member state might decide to mitigate and accept the risk. However, this risk acceptance does not change the initial risk-assessment; the site will remain non-compliant until satisfactory corrective actions are taken.

With this consultation, the EMA aims at collecting relevant information from stakeholders to help the GMP/GDP Inspectors Working Group to develop an effective and harmonised risk-based approach for dealing with the supply of critical medicines in case of serious GMP non-compliance. As a result, the outcome shall then amend the compilation of community procedures and exchange of information (CoCP) by:

  • Separating processes of risk assessment and risk control
  • Accelerating public release of non-compliance statement
  • Avoiding generation of conditioned GMP certificates along with non-compliance statements
  • Providing specific guidance for Qualified Persons to facilitate release batches of critical drug products.

The document, including the updated “Statement of non-compliance with GMP” is open for public consultation until 15 May 2018. Please refer to the original paper for more details on this.


EMA: News, Human Regulatory

No comment has yet been written about this news.
Literature recommendation
Questionnaire for preparing GMP-inspections
GMP Compliance Adviser
Single User Licence (monthly subscription)