COMPLIANCE ADVISORY
PIC/S Guide to Good Manufacturing Practice for Medicinal Products Readiness Advisory
A strategy call with someone who has spent 25 years building compliance systems used by 100,000+ professionals in 160+ countries – not a generalist who read the standard last week.
Why work with Ivanka on PIC/S Guide to Good Manufacturing Practice for Medicinal Products
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice (GMP) provides internationally harmonised GMP guidelines for medicinal product manufacturing. PIC/S has 54 participating authorities worldwide. The guide covers quality management, personnel, premises, equipment, documentation, production, quality control, outsourced activities, complaints, self-inspection, and computerised systems. The PIC/S GMP guide is largely harmonised with the EU GMP guide and WHO GMP guidelines. Annexes cover specific product types and activities.
Most consultants approach PIC/S Guide to Good Manufacturing Practice for Medicinal Products as a checkbox exercise. Ivanka approaches it as a strategic lever. With 25 years of building The Art of Service – a compliance platform now covering 692 frameworks and 819,000+ cross-framework mappings – she doesn't just understand the standard. She understands how it connects to everything else your organisation is already doing.
This matters because PIC/S Guide to Good Manufacturing Practice for Medicinal Products doesn't exist in isolation. Ivanka will map your current compliance posture against the 17 controls across 6 domains, identify gaps, and show you where existing controls from other frameworks you may already follow can be leveraged – saving months of redundant work.
Relevant credentials
- MIT Entrepreneurial Masters graduate – rigorous analytical approach to enterprise challenges
- EXIN Expert Panel member – helping shape global certification standards
THE STRATEGY CALL
What you get in 30 minutes
Ivanka reviews your PIC/S Guide to Good Manufacturing Practice for Medicinal Products readiness scores and identifies the critical gaps that carry the highest risk. No generic advice – specific to your domains and controls.
A clear, prioritised plan for addressing gaps across 6 domains. She maps what you can leverage from existing compliance work and what requires new investment.
PIC/S Guide to Good Manufacturing Practice for Medicinal Products maps to 171 other frameworks. Ivanka shows you where a single control implementation can satisfy multiple regulatory requirements at once.
Domains covered in PIC/S Guide to Good Manufacturing Practice for Medicinal Products
Plus 1 additional domains. See the full assessment →
This is for you if
- You need to achieve PIC/S Guide to Good Manufacturing Practice for Medicinal Products compliance but don’t know where to start or how to prioritise
- You’ve been told you’re “compliant” but suspect gaps exist that haven’t been properly assessed
- You manage compliance for manufacturing organisations and need expert guidance, not generic templates
- You want to leverage existing compliance efforts across multiple frameworks rather than starting from scratch
- You need a strategic plan your leadership team and board will actually understand and support
Start with a free assessment. Then let's talk strategy.
Take the free PIC/S Guide to Good Manufacturing Practice for Medicinal Products readiness diagnostic. In 5 minutes you'll have a clear picture of where your gaps are. Then book the strategy call and Ivanka will show you exactly how to close them.
Free · No login required · Results in 5 minutes
Or go directly to the $149 Report + Strategy Call