Practical pharma quality & compliance
Field-tested guidance on audits, Qualified Person duties, quality systems and inspection readiness — written by a senior QP.
The QP and the Marketing Authorisation: Staying in Scope
The QP marketing authorisation relationship explained: certifying batches in scope, handling variations and keeping release defensible at MHRA inspection.
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QP Oversight of Contract Manufacturing
Practical guidance on QP oversight CMO arrangements under EU GMP Chapter 7 and Annex 16: technical agreements, risk-based auditing and defensible batch certification.
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Importing Medicines from Third Countries: The QP's Role
QP importation third country certification explained: the QP's legal duties, importation testing, MRAs, supplier qualification and GDP for UK and EU importers.
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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.
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Writing a Quality Manual That People Actually Use
How to write a pharmaceutical quality manual that staff and inspectors actually use: lean, ICH Q10-aligned, structured for the reader and built to stay current.
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Quality Metrics and KPIs Worth Tracking
A senior QP guide to pharmaceutical quality metrics: the leading and lagging KPIs worth tracking, how to set thresholds and drive ICH Q10 review.
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Quality and Technical Agreements Explained
A quality technical agreement defines GMP and GDP responsibilities between parties. Learn what to include, how to negotiate one, and the pitfalls inspectors find.
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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.
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Remote vs On-Site GMP Audits: When to Use Each
A QP-grade guide to choosing between a remote GMP audit and on-site inspection, with a risk-based framework for when to use each and when to blend both.
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