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Manufacture of sterile medicines – Advanced workshop for SFDA GMP inspectors

Nanjing, November 2009

19 |

Raw Materials

Personnel

Procedures

Validated processes

Equipment

Premises

Environment

Packing Materials

Poorly designed or executed micro monitoring

Viable sample points not close to point of fill

The whole process is not monitored

Viable sampling does not cover all key areas under Grade A e.g. vial turntable, stopper hopper

Monitoring is not risked based and “too routine”

High pre-filtration bioburden not adequately investigated and bioburden limits >> 10cfu/100ml and no justification

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