Category: Regulatory

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Quality Risk Management Principles in Annex 1, Section 2

The use of Quality Risk Management (QRM) principles and risk-based approaches are prominent expectations throughout the Annex 1 draft. Risk-based approaches are mentioned 43 times in the draft reinforcing the importance of using Risk Based approaches in all aspects of sterile product manufacturing. Here we highlight requirements related to Quality…

Newscleanroom cleaning

Cleanroom Cleaning & Disinfection Per Annex 1, rev 12

The latest Annex 1 draft offers several updated expectations on cleanroom cleaning, decontamination and disinfection. Learn about these expectations and addressing them with a contamination control strategy (CCS) Definitions Cleaning (NEW)A process for removing contamination e.g. product residues and disinfectant residues from a cleanroom. Decontamination The overall process of removal…

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