Practical pharma quality & compliance
Field-tested guidance on audits, Qualified Person duties, quality systems and inspection readiness — written by a senior QP.
Setting Up a New Pharma Site: A Readiness Roadmap
A senior QP's phased roadmap for new pharma site setup: scope, MIA/WDA licensing, building an operating quality system, qualification and MHRA readiness.
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Building a Strong Pharmaceutical Quality Culture
A practical guide to building a strong quality culture pharma teams can defend at inspection, with behavioural markers, leadership signals and metrics under EU GMP.
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Pre-Application Readiness: What to Do Before You Apply
A senior QP's guide to licence readiness before an MIA or WDA application: scope, an operating quality system, named persons and a mock inspection.
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How to Prepare for an FDA Inspection from the UK
FDA inspection preparation for UK and EU sites: map 21 CFR 211 to EU GMP, ready your site, rehearse the team and respond to a Form 483 with confidence.
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The Product Quality Review (PQR/APQR) Explained
A senior QP guide to the product quality review (PQR/APQR): EU GMP scope, trending under ICH Q9, QP and MAH duties, and how to make it a real tool.
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A Right-Sized QMS for Small Pharma and Startups
A right-sized QMS for small pharma is proportionate, not reduced. How to build a compliant, inspection-ready PQS that scales with your pipeline.
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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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