Practical pharma quality & compliance
Field-tested guidance on audits, Qualified Person duties, quality systems and inspection readiness — written by a senior QP.
Auditing for EU GMP Annex 1: A Sterile Manufacturing Focus
A QP's practical guide to the Annex 1 audit: lead with the contamination control strategy, target the highest-risk areas, and test sterility assurance.
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Closing Out Audit Findings: A CAPA Playbook
A practical audit CAPA playbook for UK and EU pharma: classify findings by risk, do defensible root cause analysis, and close out with effectiveness checks.
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Audit Trail Review: A Practical Guide for GMP Systems
A practical, risk-based guide to audit trail review for GMP systems, aligned to Annex 11, MHRA data integrity guidance and ALCOA+ for UK and EU teams.
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How to Choose a GMP Audit Consultant: 10 Questions to Ask
Choosing a GMP audit consultant? Ask these 10 questions on competence, independence, method and deliverables to pick an auditor who protects your compliance.
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What Auditors Look For in Your Cleaning Validation
What inspectors expect in a cleaning validation audit: worst-case rationale, health-based limits, recovery studies, data integrity and ongoing verification.
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Gap Assessment vs Full GMP Audit: Where to Start
A GMP gap assessment or a full GMP audit? Learn which to choose, how they differ and where to start, with a risk-based decision guide for UK and EU quality teams.
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The Complete GMP Audit Checklist for UK Manufacturers
A practical, expert GMP audit checklist for UK manufacturers, built on EU GMP, the Annexes, ICH Q9/Q10 and ALCOA+ data integrity — by a senior QP.
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GMP Audits for Contract Manufacturers (CMOs)
A practical, QP-led guide to the CMO GMP audit: risk-based scoping, on-site conduct, data integrity, CAPA and lifecycle oversight under EU GMP and ICH Q10.
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How Often Should You Audit Your Suppliers and Sites?
How to set GMP audit frequency for suppliers and sites using a risk-based model under EU GMP and ICH Q9 — intervals, triggers and self-inspection explained.
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