Practical pharma quality & compliance
Field-tested guidance on audits, Qualified Person duties, quality systems and inspection readiness — written by a senior QP.
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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The Site Master File: A Complete Guide
A practical guide to the site master file: what EU GMP Part III requires, how to structure it to PIC/S, and how to keep it inspection-ready and current.
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SOP Management: Keeping Procedures Current and Used
SOP management for UK and EU pharma: keep procedures current, controlled and actually used at the point of use, in line with EU GMP, ICH Q10 and ALCOA+.
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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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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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Ongoing Supplier Monitoring and Performance
A senior QP guide to ongoing supplier monitoring: risk-based metrics, QMS integration, escalation and CAPA to keep your pharma supply chain inspection-ready.
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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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