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- FDA Draft Guidance for Industry Sterile Drug Products Produced by Aseptic Processin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