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- FDA Draft Guidance for Industry Sterile Drug Products Produced by Aseptic Processin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