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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

Poorly designed or maintained equipment Blow fill seal machine

Cooling water

Chills mold plates used to form the container-closure into which the sterile drug is filled.

Demineralized potable water.  Held in tank, chilled (when sampled, yields very high microbial counts)

Sterility failure and media fill failure

Pseudomonas, sp. and Acinetobacter, sp. found in media fill

Stenotrophomonas maltophilia identified as Sterility Failure isolate

Several lots rejected

Both the sterility failure and media fill failure attributed to cooling water contamination

Root cause of non-sterility was leak/s/ in aseptic filling machine’s mold plates.  Cooling water directly contaminated product.  

CAPA Issue: Exact date of problem occurrence unknown.

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