Practical pharma quality & compliance
Field-tested guidance on audits, Qualified Person duties, quality systems and inspection readiness — written by a senior QP.
Recall Management and Mock Recalls
How UK and EU quality teams should run a pharmaceutical recall and prove readiness through mock recalls, meeting MHRA, EU GMP and GDP expectations.
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Responding to MHRA Inspection Findings
A practical QP guide to building an MHRA inspection response: grading findings, CAPA, root cause, ALCOA+ evidence and realistic, defensible timelines.
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Responsible Person (RP) Duties on a WDA
A senior QP's guide to responsible person duties on a WDA: legal basis, GDP obligations, ICH Q9 risk decisions, contactability and contract RP cover.
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The Responsible Person Under GDP
A senior QP's guide to the responsible person GDP role: legal duties, personal accountability, RP vs RP(i) vs QP, and the failures that fail MHRA inspections.
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The RP Gold Standard: What the MHRA Expects
The RP gold standard explained: what the MHRA truly expects of a Responsible Person on a UK WDA(H), from product knowledge to data integrity.
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RP vs RPi vs QP: Who Does What?
The RP RPi QP difference explained: how Responsible Person, RPi and Qualified Person duties, authorisations and GMP/GDP accountabilities differ in UK pharma.
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RPi Explained: The Responsible Person for Import
A UK QP explains the responsible person import (RPi): what the role does, how it differs from the QP and RP, and how to resource it for MHRA compliance.
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Selecting a Contract Manufacturer (CMO)
A practical, QP-led guide to CMO selection under EU GMP and ICH Q9/Q10: defining requirements, risk-based criteria, due diligence, audit and quality agreements.
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Self-Inspection vs External GMP Audit: What's the Difference?
A practical QP guide to self inspection GMP versus external GMP audits: how they differ in scope, independence and purpose, and how to use both well.
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