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Manufacture of sterile medicines – Advanced workshop for SFDA GMP inspectors

Nanjing, November 2009

34 |

Raw Materials

Personnel

Procedures

Validated processes

Equipment

Premises

Environment

Packing Materials

Sterile API – unacceptable process design!

Huge Grade A/B rooms-poor differential pressures

Masses of pipe work

Redundant equipment

Cracks, crevices, ledges…….

Sterility starts here!

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