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Manufacture of sterile medicines – Advanced workshop for SFDA GMP inspectors

Nanjing, November 2009

6 |

Raw Materials

Personnel

Procedures

Validated processes

Equipment

Premises

Environment

Packing Materials

Poorly designed processes

Raw material suppliers not audited but acceptance of side samples e.g. sterile API side samples accepted with no justification

Prefilled syringe assembly sterilisation sites never audited

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