31% of ISO 22301:2019 you already have
PIC/S Guide to Good Manufacturing Practice for Medicinal Products already covers about 31% of ISO 22301:2019, leaving
27 of 39 controls as genuinely new work.
Already covered 0
Likely covered 12
New work 27
No control in PIC/S Guide to Good Manufacturing Practice for Medicinal Products
maps directly to one in ISO 22301:2019. Everything counted as covered is covered because both
map to the same third standard, which is what a crosswalk is, but it is an inference rather
than a lookup.
What is genuinely new work
Nothing in PIC/S Guide to Good Manufacturing Practice for Medicinal Products reaches these. This is the list to scope.
5.3Roles, responsibilities and authorities
6.2Objectives and planning to achieve them
7.5Documented information
7.5.2Creating and updating
7.5.3Control of documented information
8.2Business impact analysis and risk assessment
8.2.2Business impact analysis
8.3Business continuity strategies and solutions
8.3.2Identification of strategies and solutions
8.3.3Selection of strategies and solutions
8.3.4Resource requirements
8.3.5Implementation of solutions
8.4Business continuity plans and procedures
8.4.3Warning and communication
8.4.4Business continuity plans
8.6Evaluation of business continuity documentation and capabilities
Show the 12 you already have
10.1Continual improvement
10.2Nonconformity and corrective action
4.1Understanding the organization and its context
4.2Understanding the needs and expectations of interested parties
4.3Determining the scope of the management system
5.1Leadership and commitment
6.1Actions to address risks and opportunities
8.1Operational planning and control
9.1Monitoring, measurement, analysis and evaluation
How this is calculated
Already covered means a mapping runs from a control in PIC/S Guide to Good Manufacturing Practice for Medicinal Products 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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