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Manufacture of sterile medicines – Advanced workshop for SFDA GMP inspectors

Nanjing, November 2009

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Construction activities

Major construction in cleanroom next to personnel entry airlock (e.g., gowning).

Construction occurred over approximately one-month period and coincided with continued production

Media Fill Failure 2 weeks later  

Construction not considered to be the cause.  Root causes identified by investigation considered corrected.

New Media Fill performed

Second Media Fill Failure Occurred

Contamination attributed to construction

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