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Xenia Dimont
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Xenia Dimont

Pharmaziedirektorin, Regierung von Oberbayern, München.

Published articles

Contamination Control Strategy – What is the Inspector’s Point of View?

Contamination Control Strategy – What is the Inspector’s Point of View?

The Contamination Control Strategy (CCS) is one of the few genuinely new requirements in the revised Annex 1. While Annex 1 provides quite comprehensive information on the content, the formal structure is not prescribed. In today’s feature you will read about an inspector’s point of view concerning the creation of this document, the responsibilities for review and approval, and the expectations for the first inspections to come.

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Sterile Filtration (PUPSIT)

Sterile Filtration (PUPSIT)

The term "PUPSIT", which stands for the Pre-Use Post-Sterilization Integrity Test, has been included in the revised Annex 1. While the term is new, the requirement to check the integrity of a sterilizing filter after it has been sterilized and before it is used for sterile filtration is not new. This has been included in Annex 1 since 1998.

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