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Manufacture of sterile medicines – Advanced workshop for SFDA GMP inspectors

Nanjing, November 2009

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Raw Materials

Personnel

Procedures

Validated processes

Equipment

Premises

Environment

Packing Materials

Media fills!

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

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