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Manufacture of sterile medicines – Advanced workshop for SFDA GMP inspectors

Nanjing, November 2009

7 |

Raw Materials

Personnel

Procedures

Validated processes

Equipment

Premises

Environment

Packing Materials

Poor clean room and aseptic practices

Filling needles installed & left unprotected while remainder of line set up still taking place Not routinely recorded/documented

No monitoring during equipment set up

Allowed interventions into aseptic zone are not derived from risk based process review

Systems/Procedures not clear what to do upon intervention

Interventions not linked to batch release process

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