Search results for "QRM"
Article
Essentials in Quality Risk Management
Quality risk management (QRM), as defined in International Conference on Harmonization's (ICH) Q9 document (1), is designed to ensure that drug critical quality attributes (CQAs) are defined and maint…
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
From a quality risk management (QRM) perspective, the risks are usually around product/material compatibility (e.g., leachables, etc.). While one risk source may effectively be transferred outside, th…
Article
Advancing QbD in the EU
These guidelines cover pharmaceutical development concepts in Q8, quality risk management (QRM) in Q9, and a pharmaceutical quality system to be implemented in the different stages of a product lifecy…
Article
PDA's Technical Report for Biotech Cleaning Validation
RISK MANAGEMENT AND ASSESSMENT
Quality risk management (QRM) involves elements of risk assessment, risk control, and periodic review to ensure continuous and effective control (6). It is important…