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Manufacture of sterile medicines – Advanced workshop for SFDA GMP inspectors

Nanjing, November 2009

18 |

Raw Materials

Personnel

Procedures

Validated processes

Equipment

Premises

Environment

Packing Materials

Poorly designed or executed PM monitoring

Reliance on the use of contact plates and no use of swabs

Reliance on active air monitoring and inadequate use of settle plates

“Averaging into compliance” – inadequate attention to the individual high count

Acceptance of “good pattern” of very low contamination and failure to evaluate whether the programme is effective.

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