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.
You may also be interested in...
ICH Q9 draft published for public consultation; changes focus on addressing subjectivity in quality risk management and managing risk for supply chains, among other topics.
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.