Practical pharma quality & compliance
Field-tested guidance on audits, Qualified Person duties, quality systems and inspection readiness — written by a senior QP.
How to Become a Qualified Person in the UK
A senior practitioner's guide to how to become a qualified person in the UK: the degree, experience and eligibility viva needed to certify and release batches.
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Interim QP Cover: Keeping Release Moving During Absence
How an interim qualified person keeps batch release and MIA compliance moving during QP absence, with practical planning, handover and data-integrity guidance.
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The QP's Role for Investigational Medicinal Products (IMPs)
How QP IMP certification works under EU GMP Annex 13 and MHRA rules: the release decision, importation, comparators, labelling and the risks inspectors probe.
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The QP and the Marketing Authorisation: Staying in Scope
The QP marketing authorisation relationship explained: certifying batches in scope, handling variations and keeping release defensible at MHRA inspection.
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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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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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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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What Does a Qualified Person Actually Do?
What does a qualified person do? A senior UK QP explains batch certification, legal duties, GMP oversight and when to use a contract QP for release.
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