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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Extension will add training materials with goal of reducing quality defects and recalls. Revision process will also address shortage indicators related to production failures in an attempt to head off drug shortages.
The ICH Management Committee has endorsed four quality topics for revision in its workplan recommended by its Quality Discussion Group, including a groundbreaking new guideline covering the assessment and control of extractables and leachables of drug containers.
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.