Practical pharma quality & compliance
Field-tested guidance on audits, Qualified Person duties, quality systems and inspection readiness — written by a senior QP.
GDP Risk Assessment: Where to Focus
A practical GDP risk assessment guide for UK and EU quality teams: where to focus effort across cold chain, suppliers and returns to satisfy the MHRA.
Read more
Running a GDP Self-Inspection
A senior QP's practical guide to running a GDP self inspection: scope, independent auditors, ALCOA+ records, CAPA and staying MHRA inspection-ready.
Read more
Qualifying Shipping Lanes for Pharmaceuticals
A UK QP's guide to shipping lane qualification under EU and UK GDP: risk-based route mapping, seasonal temperature profiling and continuous monitoring.
Read more
Recall Management and Mock Recalls
How UK and EU quality teams should run a pharmaceutical recall and prove readiness through mock recalls, meeting MHRA, EU GMP and GDP expectations.
Read more
The Responsible Person Under GDP
A senior QP's guide to the responsible person GDP role: legal duties, personal accountability, RP vs RP(i) vs QP, and the failures that fail MHRA inspections.
Read more
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.
Read more
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.
Read more
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.
Read more
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.
Read moreReady to get inspection-ready?
Book a no-obligation discovery call to talk through your audit, QP/RP or quality-system needs.