Practical pharma quality & compliance
Field-tested guidance on audits, Qualified Person duties, quality systems and inspection readiness — written by a senior QP.
Supplier Risk Assessment: A Practical Method
A senior QP's practical method for supplier risk assessment: define criteria, score consistently and map risk bands to proportionate, inspection-ready oversight.
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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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Temperature Mapping of Warehouses and Storage
A senior QP's guide to temperature mapping of warehouses and storage: protocol design, sensor placement, ALCOA+ data, excursions and requalification under GDP.
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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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Verifying GMP Certificates and EudraGMDP
A senior QP's guide to GMP certificate verification using EudraGMDP and MHRA: scope, validity, non-compliance checks and a defensible QMS workflow.
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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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