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Manufacture of sterile medicines – Advanced workshop for SFDA GMP inspectors

Nanjing, November 2009

4 |

Raw Materials

Personnel

Procedures

Validated processes

Equipment

Premises

Environment

Packing Materials

Poorly designed processes

Single filtration

Filtration not performed as close as practicable to the filling point

Inadequate response to leaking containers – no limits set to prompt an investigation

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