Regulators Led Bid To Strengthen ICH Q9 Quality Risk Management
Inconsistency among pharmaceutical quality risk assessments drove regulatory authorities' surprise insistence on revising the ICH's 15-year-old Q9 guideline.
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An international guideline on managing post approval changes to drugs, which was initially criticized because of its incompatibility with legal frameworks in certain ICH regions such as the EU, has been finalized.
Despite the benefits in improving product quality and reducing product defects, the pharmaceutical industry is still struggling to incorporate ICH Q9 quality risk management principles into quality operations, and even more dispiriting, there is still lingering uncertainty on what constitutes quality risk management.
A high percentage of pharmaceutical companies say they have the quality risk management programs in their manufacturing facilities that US and EU inspectors are asking for. But many of them are not yet very mature.