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Manufacture of sterile medicines – Advanced workshop for SFDA GMP inspectors

Nanjing, November 2009

31 |

Raw Materials

Personnel

Procedures

Validated processes

Equipment

Premises

Environment

Packing Materials

Steam Sterilisation & SIP systems!

Air removal from equipment not adequately considered

Steam quality not assessed adequately

Non-condensable gases

Wet steam (Dryness fraction)

Superheat Clean steam quality tests are not performed at distal points of the distribution system. Steam quality test not performed following modifications

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