ICH To Add Guidance On Impurities, Viral Safety, Risk Management And Quality Overall Summary
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.
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New approach could eliminate minor differences among authorities, enabling pharmaceutical manufacturing processes to become truly global.
Inconsistency among pharmaceutical quality risk assessments drove regulatory authorities' surprise insistence on revising the ICH's 15-year-old Q9 guideline.
The ICH Informal Quality Discussion Group considers an array of proposed new and revised quality guidelines and asks members for additional ideas.