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TSB 2023/083: Overview of West Contamination Control Strategy

Provides insights into West’s approach to support drug manufacturers with their efforts to meet requirements per EU GMP Annex I “Manufacture of Sterile Medicinal Products"
This high-level overview of West's contamination control strategy considers all elements of the manufacturing process to safeguard product quality from particulate, endotoxin/pyrogen and bioburden contamination for West ready-to-sterilize (washed) and ready-to-use (washed and sterilized) products.

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