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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 or maintained equipment

Viewing ports on sterilising tunnels not adequately sealed

Lyophilisers not sterilisable or not sterilised sufficiently frequently

Vial capping performed under uncontrolled conditions

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