How can the specific requirements for sterile products be taken into account in the quality management system?

11.03.2024

Question of the Week

The Pharmaceutical Quality System (PQS) of a sterile manufacturer should cover the specific requirements of sterile products and thus ensure that the risk of particulate and microbial contamination (including endotoxins) is minimized.

[GMP Compliance Adviser, Chapter 12.C]

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