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Manufacture of sterile medicines – Advanced workshop for SFDA GMP inspectors

Nanjing, November 2009

8 |

Raw Materials

Personnel

Procedures

Validated processes

Equipment

Premises

Environment

Packing Materials

Poor clean room and aseptic practices

Interventions not linked to batch release process

Excessive numbers of manipulations

Excessive numbers of people

People routinely located in the class A zone

Failure to use isolation and closed techniques

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