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Manufacture of sterile medicines – Advanced workshop for SFDA GMP inspectors

Nanjing, November 2009

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Raw Materials

Personnel

Procedures

Validated processes

Equipment

Premises

Environment

Packing Materials

Poorly designed processes

Materials transferred into Aseptic area with insufficient sterility assurance

Poor transfer of partially stoppered vials to lyophiliser

Excessive holding times for sterile equipment or filtered solutions

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