Which quality and process parameters must typically be taken into account during process validation for terminally sterilized products?

04.03.2024

Question of the Week

Sterility, endotoxins and particles are key quality aspects in the validation of manufacturing processes for sterile medicinal products. A risk analysis is carried out to identify the critical process steps and critical process parameters.

[GMP Compliance Adviser, Chapter 12.C]

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How is a QRM process initiated?

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