Practical pharma quality & compliance
Field-tested guidance on audits, Qualified Person duties, quality systems and inspection readiness — written by a senior QP.
Importing Medicines from Third Countries: The QP's Role
QP importation third country certification explained: the QP's legal duties, importation testing, MRAs, supplier qualification and GDP for UK and EU importers.
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Writing a Quality Manual That People Actually Use
How to write a pharmaceutical quality manual that staff and inspectors actually use: lean, ICH Q10-aligned, structured for the reader and built to stay current.
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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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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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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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Designing a Supplier Audit Programme
How to design a risk-based supplier audit programme that satisfies the MHRA: scope, ICH Q9 risk tiering, scheduling, CAPA closure and meaningful metrics.
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