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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 executed PM monitoring

Length of tubing to particle counter too long & even kinked!

PMS data not reviewed as part of batch release process

Overseas-use of manifold systems and no 5 micron monitoring

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