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Practical pharma quality & compliance

Field-tested guidance on audits, Qualified Person duties, quality systems and inspection readiness — written by a senior QP.

Good Distribution Practice (GDP): The Essentials
GDP Transport & Supply Chain· 7 min

Good Distribution Practice (GDP): The Essentials

A senior QP's guide to good distribution practice: WDA(H), the Responsible Person, cold chain, data integrity and the pitfalls that fail MHRA inspections.

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GDP Requirements for Couriers and 3PLs
GDP Transport & Supply Chain· 7 min

GDP Requirements for Couriers and 3PLs

A senior QP's guide to GDP courier requirements: temperature control, security, traceability, audits and quality agreements for couriers and 3PLs in transit.

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How Often Should You Audit Your Suppliers and Sites?
GMP & GDP Audits· 7 min

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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GMP Audit vs GDP Audit: Which Does Your Business Need?
GMP & GDP Audits· 7 min

GMP Audit vs GDP Audit: Which Does Your Business Need?

A senior QP's guide to the GMP vs GDP audit decision: what each covers, the frameworks behind them, and how to scope the right audit for your UK or EU business.

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How to Apply for a Wholesale Dealer's Authorisation (WDA)
Site Readiness (MIA/WDA)· 7 min

How to Apply for a Wholesale Dealer's Authorisation (WDA)

Learn how to apply for a WDA in the UK: scope, the Responsible Person, a GDP-aligned QMS, the MHRA process and pre-approval inspection readiness.

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How to Become a Qualified Person in the UK
Contract QP, RP & RPi· 7 min

How to Become a Qualified Person in the UK

A senior practitioner's guide to how to become a qualified person in the UK: the degree, experience and eligibility viva needed to certify and release batches.

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ICH Q10 Explained: The Pharmaceutical Quality System
QMS & PQS Implementation· 7 min

ICH Q10 Explained: The Pharmaceutical Quality System

ICH Q10 explained: the four elements, two enablers and management responsibility behind an effective pharmaceutical quality system under EU GMP and MHRA.

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Interim QP Cover: Keeping Release Moving During Absence
Contract QP, RP & RPi· 7 min

Interim QP Cover: Keeping Release Moving During Absence

How an interim qualified person keeps batch release and MIA compliance moving during QP absence, with practical planning, handover and data-integrity guidance.

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The Management Review Meeting: Making It Count
QMS & PQS Implementation· 7 min

The Management Review Meeting: Making It Count

A practical guide to management review pharma teams can use: ICH Q10 inputs, the right attendees, cadence and turning data into board-level decisions.

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