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The Pharmaceutical BFS International Operators Association
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    • European meeting 2023 | Catania, Italy
    • North Africa/Middle East seminar 2023 | Cairo, Egypt
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Links

Links

Following are links to different documents and regulations of interest to BFS operations.

NOTE: BFS IOA does not claim any responsibilites that information is current or valid.

  • Data Integrity and GMP Compliance (Apr'2016)

  • EU GMP Revisions Annex 1 - Concept paper on the revision of annex 1 of the guidelines on good manufacturing practice – manufacture of sterile medicinal product (Feb'2016)

  • Position Paper of EDQM regarding particles in Eye Drops (Mar'2015)

  • FDA Current Good Manufacturing Practice - Guidance for Industry for Sterile Drug Products Produced by Aseptic Processing  - (Sep'2004)
  • FDA Draft Guidance for Industry Sterile Drug Products Produced by Aseptic Processin
    - Published August 2003

  • FDA Concept Paper on Aseptic Processing
    - Published September 27, 2002
     

BFS IOA
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Hartvig Jensensvej 1
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BFS@melitek.com
Phone: +45 70 250 255
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