Practical pharma quality & compliance
Field-tested guidance on audits, Qualified Person duties, quality systems and inspection readiness — written by a senior QP.
Batch Certification vs Batch Release: The Difference
A QP's guide to batch certification vs release: what each act means under Annex 16, who is accountable, and why certification must always come before release.
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Contract QP vs In-House QP: Cost, Risk and Control
Contract QP vs in-house: compare cost, compliance risk and control for UK and EU batch certification, and choose the right Qualified Person model for your site.
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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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Naming a QP on Your Manufacturing Licence
How to name a QP on a licence the right way: eligibility, scope, MHRA variations and governance for your UK or EU MIA, with employed or contract QPs.
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The QP Declaration Explained for Importers
What a QP declaration is, why importers need one, and the audit evidence behind it. A practical guide to GMP equivalence under EU GMP, MHRA and ICH Q9/Q10.
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QP Eligibility and the Viva: How Assessment Works
How the QP viva and eligibility assessment work: the degree, experience, sponsor and panel interview that confirm you are fit to certify batches.
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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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