Manufacture of sterile medicines – Advanced workshop for SFDA GMP inspectors
Nanjing, November 2009
The belief that some contamination is OK!
Acceptance criteria does not meet Annex 1 & allows 1 failure to be accepted with no effective investigation
Poor practices accepted as covered & justified by “passing” Media Fills!
Good history does not mean failures/growth need not be investigated
Implications to batches on the market or in stock subsequent to failures are not always considered fully