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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Responsible Person (RP) Duties on a WDA
A senior QP's guide to responsible person duties on a WDA: legal basis, GDP obligations, ICH Q9 risk decisions, contactability and contract RP cover.
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The RP Gold Standard: What the MHRA Expects
The RP gold standard explained: what the MHRA truly expects of a Responsible Person on a UK WDA(H), from product knowledge to data integrity.
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RP vs RPi vs QP: Who Does What?
The RP RPi QP difference explained: how Responsible Person, RPi and Qualified Person duties, authorisations and GMP/GDP accountabilities differ in UK pharma.
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RPi Explained: The Responsible Person for Import
A UK QP explains the responsible person import (RPi): what the role does, how it differs from the QP and RP, and how to resource it for MHRA compliance.
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What Does a Qualified Person Actually Do?
What does a qualified person do? A senior UK QP explains batch certification, legal duties, GMP oversight and when to use a contract QP for release.
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When Do You Need a Contract Qualified Person? A Practical Guide
Between permanent QPs, opening a new site, or scaling fast? Here is how to know when a contract QP, RP or RPi is the right call — and how to use one well.
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