Practical pharma quality & compliance
Field-tested guidance on audits, Qualified Person duties, quality systems and inspection readiness — written by a senior QP.
Qualifying API Suppliers
A practical UK QP guide to API supplier qualification: risk-ranking, documented evidence, on-site audits and ongoing oversight aligned to EU GMP and ICH Q9/Q10.
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Building and Maintaining an Approved Supplier List
How to build and maintain an approved supplier list that satisfies EU GMP, GDP and the MHRA: risk-based qualification, scope, change control and review.
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When and How to Disqualify a Supplier
A practical QP guide to supplier disqualification: when to trigger it under ICH Q9 and Q10, how to do it without disrupting supply, and the path back.
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Qualifying Excipient Suppliers
A UK QP's practical guide to excipient supplier qualification: risk assessment under ICH Q9, qualification dossiers, audits, controls and re-qualification.
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Quality and Technical Agreements Explained
A quality technical agreement defines GMP and GDP responsibilities between parties. Learn what to include, how to negotiate one, and the pitfalls inspectors find.
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Selecting a Contract Manufacturer (CMO)
A practical, QP-led guide to CMO selection under EU GMP and ICH Q9/Q10: defining requirements, risk-based criteria, due diligence, audit and quality agreements.
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Single vs Dual Sourcing: Managing Supply Risk
A practical UK QP guide to dual sourcing pharma vs single sourcing: use ICH Q9 to weigh supply risk, qualification cost and patient safety.
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Designing a Supplier Audit Programme
How to design a risk-based supplier audit programme that satisfies the MHRA: scope, ICH Q9 risk tiering, scheduling, CAPA closure and meaningful metrics.
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Supplier Bona Fides and the Falsified Medicines Directive
How UK and EU quality teams verify supplier bona fides under the Falsified Medicines Directive and GDP, with practical checks, red flags and QMS controls.
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