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GMP Inspections in Europe: Proven Strategies on How to Prepare

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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


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News about GMP/cGMP

EDQM Strengthens Intern. Collaboration

The European Directorate for the Quality of Medicines & Healthcare (EDQM, Council of Europe) is strengthening its collaboration with renowned international organisations in the field of medicines by signing Memorandums of Understanding (MoU) with the National Institute of Food and Drug Safety Evaluation (NIFDS), Korea Food and Drug Administration, and the Chinese National Institute of Food and Drug Control (NIFDC), respectively.


The overall objectives of the parties are to:

  • increase awareness of the importance of the quality and safety of medicines;
  • establish a basis for, and promote cooperation between, the parties; and
  • identify areas of mutual interest and possible collaboration.

Potential areas include common subjects of interest such as cooperation in the development of monographs and the establishment and management of reference substances, research projects of mutual interest, joint efforts in the organisation of scientific training, conferences and workshops and exchange of staff.



Increasing international collaboration is an emerging issue. The collaboration between european and asian agencies is another step towards worlwide accepted quality standards.



EDQM/ Announcement


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