78% of PIC/S Guide to Good Manufacturing Practice for Medicinal Products you already have
ISO/IEC 27003:2017 already covers about 78% of PIC/S Guide to Good Manufacturing Practice for Medicinal Products, leaving
2 of 9 controls as genuinely new work.
Already covered 7
Likely covered 0
New work 2
What is genuinely new work
Nothing in ISO/IEC 27003:2017 reaches these. This is the list to scope.
PICSGMP-6Chapter 6: Quality Control, Testing, Batch Release
PICSGMP-9Chapter 9: Self Inspection and Continuous Improvement
Show the 7 you already have
PICSGMP-1Chapter 1: Pharmaceutical Quality System (PQS) and Quality Risk Management
PICSGMP-2Chapter 2: Personnel - Qualified Personnel, Key Responsibilities, Training
PICSGMP-3Chapter 3: Premises and Equipment - Design, Qualification, Calibration
PICSGMP-4Chapter 4: Documentation - System, Record-Keeping, Data Integrity
PICSGMP-5Chapter 5: Production Operations and Material Management
PICSGMP-7Chapter 7: Outsourced Activities and Supplier Management
PICSGMP-8Chapter 8: Complaints, Quality Defects, Product Recall
How this is calculated
Already covered means a mapping runs from a control in ISO/IEC 27003:2017 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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