Framework overlap

Does PIC/S Guide to Good Manufacturing Practice for Medicinal Products cover ISO 31000:2018?

You hold PIC/S Guide to Good Manufacturing Practice for Medicinal Products and have been told to do ISO 31000:2018. Here is how much overlaps, control by control.

23% of ISO 31000:2018 you already have

PIC/S Guide to Good Manufacturing Practice for Medicinal Products already covers about 23% of ISO 31000:2018, leaving 40 of 52 controls as genuinely new work.

Already covered 1 Likely covered 11 New work 40

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.

4.a
Integrity Principle
4.b
Fair Presentation
4.c
Due Professional Care
4.d
Confidentiality
4.e
Independence
4.f
Evidence-Based Approach
5.4.2
Articulating risk management commitment
5.4.3
Assigning organizational roles, authorities, responsibilities and accountabilities
5.4.4
Allocating resources
5.4.5
Establishing communication and consultation
5.5
Implementing Audit Programme
5.6
Monitoring Audit Programme
5.7
Threat intelligence
6.3.1
Defining the scope
6.3.2
External and internal context
6.3.3
Defining risk criteria
6.4.3
Risk analysis
6.4.4
Risk evaluation
6.5.2
Selection of risk treatment options
6.5.3
Preparing and implementing risk treatment plans
6.5.4
Residual risk treatment
5.3
Integration
5.4
Design
5.4.2
Articulating risk management commitment
5.4.4
Allocating resources
5.4.5
Establishing communication and consultation
5.6
Evaluation
5.7
Improvement
5.7.1
Adapting
5.7.2
Continually improving
6.2
Communication and consultation
6.3.2
Defining the scope
6.3.3
External and internal context
6.3.4
Defining risk criteria
6.4.2
Risk identification
6.4.3
Risk analysis
6.4.4
Risk evaluation
6.5.2
Selection of risk treatment options
6.5.3
Preparing and implementing risk treatment plans
6.6
Monitoring and review
Show the 12 you already have
6.7
Conducting Audit Follow-up
4.g
Risk-Based Approach
4.h
Continual improvement
6.5.1
General risk treatment
6.6
Confidentiality or non-disclosure agreements
5.2
Leadership and commitment
5.4.1
Understanding the organization and its context
5.5
Implementation
6.3
Scope, context and criteria
6.4
Risk assessment
6.5
Risk treatment
6.7
Recording and reporting

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.

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