83% of ICH Q10 you already have
API 1164 already covers about 83% of ICH Q10, leaving
1 of 6 controls as genuinely new work.
Already covered 3
Likely covered 2
New work 1
What is genuinely new work
Nothing in API 1164 reaches these. This is the list to scope.
ICH-Q10-Lifecycle-PharmDev-TechTransfer-CommMfg-ProductDiscontinuationICH Q10 - 4 Product Lifecycle Stages - Pharmaceutical Development + Technology Transfer + Commercial Manufacturing + Product Discontinuation
Show the 5 you already have
ICH-Q10-Section1-Enablers-KnowledgeMgmt-QRM-FoundationICH-Q8-Q9ICH Q10 Section 1 - PQS Enablers + Knowledge Management + Quality Risk Management (ICH Q9 Foundation)
ICH-Q10-Section2-Outsourced-Ownership-Vendor-Supplier-CMO-CROICH Q10 Section 2 - Outsourced Activities + Management of Materials + Change of Ownership + CMO + CRO + Supplier Management
ICH-Q10-Section3-ContinualImprovement-ProcessPerformance-CAPA-ChangeMgmt-MgmtReviewICH Q10 Section 3 - Continual Improvement + Process Performance and Product Quality Monitoring + CAPA + Change Management + Management Review
ICH-Q10-Scope-PQS-ICH-Q8-Q9-Q11-Q12-ISO9001-GMP-CoordICH Q10 - Scope + Pharmaceutical Quality System (PQS) + ICH Q8/Q9/Q11/Q12 + ISO 9001 + GMP Coordination
ICH-Q10-Section2-MgmtResponsibility-Leadership-QualityPolicy-Planning-ReviewICH Q10 Section 2 - Management Responsibility + Leadership + Quality Policy + Planning + Resources + Communication + Management Review
How this is calculated
Already covered means a mapping runs from a control in API 1164 to that control. Likely
covered means no direct mapping exists but both frameworks map to the same control in a third
standard. New work means neither. We keep those separate rather than adding them into one
friendlier number, because blending them would present a two-hop inference as a verified
fact.
Coverage is not symmetric.
Run it the other way and you will get a
different number; both are correct.
From 332,959 cross-framework control
mappings across 723 frameworks, 531 of them verified against
their source documents. It does not tell you that you are compliant: a mapped control means
the two standards ask for the same thing, not that you have done it.
Try another pair ยท
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