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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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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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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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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Managing Supplier Change Notifications
A practical guide to supplier change control for UK and EU pharma teams: receiving, triaging and closing supplier change notifications under EU GMP and GDP.
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The Supplier Qualification Process, Step by Step
A practical, step-by-step guide to the supplier qualification process under EU GMP, GDP and ICH Q9, from risk classification to audits and re-qualification.
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Writing a Supplier Quality Questionnaire
How to write a supplier questionnaire that delivers real risk intelligence: risk-tiered, evidence-led and aligned to EU GMP, GDP and ICH Q9/Q10.
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Vendor Performance KPIs for Quality Teams
How to design vendor KPIs that give pharma quality teams inspection-ready, risk-weighted supplier oversight aligned with EU GMP, GDP and ICH Q9/Q10.
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