Practical pharma quality & compliance
Field-tested guidance on audits, Qualified Person duties, quality systems and inspection readiness — written by a senior QP.
Gap Assessment vs Full GMP Audit: Where to Start
A GMP gap assessment or a full GMP audit? Learn which to choose, how they differ and where to start, with a risk-based decision guide for UK and EU quality teams.
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The Complete GMP Audit Checklist for UK Manufacturers
A practical, expert GMP audit checklist for UK manufacturers, built on EU GMP, the Annexes, ICH Q9/Q10 and ALCOA+ data integrity — by a senior QP.
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GMP Audits for Contract Manufacturers (CMOs)
A practical, QP-led guide to the CMO GMP audit: risk-based scoping, on-site conduct, data integrity, CAPA and lifecycle oversight under EU GMP and ICH Q10.
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How Often Should You Audit Your Suppliers and Sites?
How to set GMP audit frequency for suppliers and sites using a risk-based model under EU GMP and ICH Q9 — intervals, triggers and self-inspection explained.
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Writing a GMP Audit Report That Drives Real Change
How to write a GMP audit report that withstands MHRA scrutiny and drives real change: specific findings, risk-based grading, ALCOA+ and closable CAPA.
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GMP Audit vs GDP Audit: Which Does Your Business Need?
A senior QP's guide to the GMP vs GDP audit decision: what each covers, the frameworks behind them, and how to scope the right audit for your UK or EU business.
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How to Run a Supplier GMP Audit, Step by Step
A practical, risk-based guide to running a supplier GMP audit: planning, on-site conduct, classifying findings, and verifying CAPA, aligned to EU GMP and MHRA.
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Mock Inspections: How a Dry Run Prevents Real Findings
A mock inspection pharma dry run simulates an MHRA or EU GMP inspection so you catch and fix findings privately, before a regulator ever writes them up.
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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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