Practical pharma quality & compliance
Field-tested guidance on audits, Qualified Person duties, quality systems and inspection readiness — written by a senior QP.
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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Training Management for a GMP Workforce
A practical guide to GMP training for UK and EU pharma teams: risk-based matrices, ALCOA+ records, competence assessment and inspection-ready evidence.
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How to Apply for a Wholesale Dealer's Authorisation (WDA)
Learn how to apply for a WDA in the UK: scope, the Responsible Person, a GDP-aligned QMS, the MHRA process and pre-approval inspection readiness.
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How to Apply for a Manufacturer's Licence (MIA)
A senior QP's guide to apply for an MIA licence in the UK: scope, the Site Master File, the MHRA pre-licensing inspection, the named QP and avoiding delays.
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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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