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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

Packaging and post sterilisation damage!

Failure to meet GMP:

Rough handling of bulk finished vials resulted in difficult to detect and hairline cracks in bottle.  “Washdown” of vials with potable water was apparent contamination source.

Patients Infected: multiple blood cultures yield Enterobacter cloacae.

At least one lot “directly implicated” in septicemia

Over 25 Septicemia Reports naming the lot or “unknown”

Class 1 Recall: Eleven Lots (“strong likelihood that product will cause serious adverse health consequences or death”)

Cultures of unopened vials grew Enterobacter cloacae

Several water samples collected at firm from the water hose/sink found Enterobacter cloacae

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