Manufacture of sterile medicines – Advanced workshop for SFDA GMP inspectors
Nanjing, November 2009
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