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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
Outcome:

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.

Link:

EMA FAQ on GMPs

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