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Manufacture of sterile medicines – Advanced workshop for SFDA GMP inspectors

Nanjing, November 2009

22 |

Raw Materials

Personnel

Procedures

Validated processes

Equipment

Premises

Environment

Packing Materials

Steam Sterilisation!

Leak test/Bowie Dick test not performed sufficiently frequently on equipment sterilisers and failures fully investigated.

Poor control of checking acceptability of autoclave cycles

Engineering work not recorded

No trial runs after major breakdowns to show autoclave still meets validated parameters

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