Practical pharma quality & compliance
Field-tested guidance on audits, Qualified Person duties, quality systems and inspection readiness — written by a senior QP.
Named Persons on a Licence: QP, RP and Production
Named persons licence guide: how the QP, RP, RPi and production roles work on a UK MIA or WDA, their eligibility, scope, authority and inspection readiness.
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Setting Up a New Pharma Site: A Readiness Roadmap
A senior QP's phased roadmap for new pharma site setup: scope, MIA/WDA licensing, building an operating quality system, qualification and MHRA readiness.
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Pre-Application Readiness: What to Do Before You Apply
A senior QP's guide to licence readiness before an MIA or WDA application: scope, an operating quality system, named persons and a mock inspection.
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Responding to MHRA Inspection Findings
A practical QP guide to building an MHRA inspection response: grading findings, CAPA, root cause, ALCOA+ evidence and realistic, defensible timelines.
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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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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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From Plan to Licence: Getting Site-Ready for an MIA or WDA
Applying for a manufacturing or wholesale licence? Here is the six-stage journey from gap assessment to a granted MIA/WDA — and where projects usually stall.
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