Pharmaceutical Industry Not 'Reaping the Benefits' Of Quality Risk Management Tools, Expert Says
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.
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Inconsistency among pharmaceutical quality risk assessments drove regulatory authorities' surprise insistence on revising the ICH's 15-year-old Q9 guideline.
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.
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”