Practical pharma quality & compliance
Field-tested guidance on audits, Qualified Person duties, quality systems and inspection readiness — written by a senior QP.
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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Managing Temperature Excursions
A practical, risk-based guide to managing a temperature excursion under EU GDP and MHRA: detection, investigation, disposition and CAPA done right.
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Transport Validation for Medicinal Products
A practical UK guide to transport validation for medicinal products: GDP duties, ICH Q9/Q10 risk, cold-chain qualification, ALCOA+ data and supplier oversight.
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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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What Does a Qualified Person Actually Do?
What does a qualified person do? A senior UK QP explains batch certification, legal duties, GMP oversight and when to use a contract QP for release.
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What Triggers an MHRA Inspection?
A senior QP guide to MHRA inspection triggers - from risk-based cycles and new applications to recalls, CAPA failures and data integrity signals.
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Good Distribution Practice: Protecting Medicines Across the Supply Chain
Temperature excursions, weak documentation and unqualified partners are where GDP fails. Here are the six controls that protect the chain from dispatch to delivery.
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