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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


>>> Click here to find more Downloads!

News about GMP/cGMP

EMA FAQ on GMP Topics

While EMA (EMEA) welcomes questions on its activities and the regulatory framework within which it operates, specific questions on the interpretation of GMP requirements should be addressed, ideally by the Qualified Person, directly to the relevant supervisory authority of the Member State in which the manufacturing authorisation holder is located. Manufacturers based in third countries should make contact through the Qualified Person of the authorised importer.


From time to time EMA (EMEA) publishes the answers to frequently asked questions following discussion and agreement of the GMP/GDP Inspectors Working Group and they are published on this page.

There are four topics of questions and answers, covering several subitems:

  • EU GMP Guide Part I Basic Requirements for Medicinal Products
    - Chapter 5 Qualification of suppliers
  • EU GMP Guide Part II Basic Requirements for Active Substances used as Starting Materials
    - GMP compliance for Active Substances
    - GMP compliance for Active Substances in IMPs
  • EU GMP Guide Annexes - Supplementary Requirements
    - Annex 1 Manufacture of Sterile Medicinal Products
    - Annex 8 Sampling of Starting and Packaging Materials
    - Annex 13
  • Miscellaneous 
    - General GMP
    - GMP Certificates

Check the information provided by EMA (EMEA), because it gives you a review on cGMP-developements and offers you first-hand information from the inspectors point-of-view.



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