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• FDA Draft Guidance for Industry Sterile Drug Products Produced by Aseptic Processin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