Practical pharma quality & compliance
Field-tested guidance on audits, Qualified Person duties, quality systems and inspection readiness — written by a senior QP.
The Product Quality Review (PQR/APQR) Explained
A senior QP guide to the product quality review (PQR/APQR): EU GMP scope, trending under ICH Q9, QP and MAH duties, and how to make it a real tool.
Read more
The QP Declaration Explained for Importers
What a QP declaration is, why importers need one, and the audit evidence behind it. A practical guide to GMP equivalence under EU GMP, MHRA and ICH Q9/Q10.
Read more
QP Eligibility and the Viva: How Assessment Works
How the QP viva and eligibility assessment work: the degree, experience, sponsor and panel interview that confirm you are fit to certify batches.
Read more
The QP's Role for Investigational Medicinal Products (IMPs)
How QP IMP certification works under EU GMP Annex 13 and MHRA rules: the release decision, importation, comparators, labelling and the risks inspectors probe.
Read more
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.
Read more
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.
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
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.
Read more
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.
Read moreReady to get inspection-ready?
Book a no-obligation discovery call to talk through your audit, QP/RP or quality-system needs.