Help Me GMP

Help Me GMP

Knowledge Hub

Key GDP Documents

Trusted GDP Source Groups

Start from trusted GDP source groups to reach official distribution guidance, registers, legislation, and practical reference material for wholesale distribution and supply chain assurance. With thanks to Dave Rushton of the UK GDP Association for helping create this GDP resource page.

Source Groups

Quick Access

MHRA GMP and GDP Guidance

MHRA guidance covering Good Manufacturing Practice and Good Distribution Practice expectations.

EU GDP Guidelines

EU guidelines on Good Distribution Practice for medicinal products for human use.

MHRA Inspectorate GDP Blog

MHRA Inspectorate blog posts and updates on Good Distribution Practice.

UK GDP Association

UK GDP Association resources and sector information for distribution professionals.

Human Medicines Regulations 2012

UK statutory framework for human medicines, including supply and distribution controls.

Directive 2001/83/EC

Community code relating to medicinal products for human use.

EMA Good Distribution Practice

EMA overview of GDP compliance and post-authorisation distribution expectations.

EMA GMP and GDP Q&A

EMA questions and answers covering GMP and GDP interpretation and compliance topics.

MHRA Guidance Note 6

Guidance covering WDA(H), broker registration, and Brexit-related GDP licence changes.

W2 Cleanroom Consulting

Sponsor support

Keeping Help Me GMP free to use

We would like to thank our channel and app sponsor, W2 Cleanroom Consulting, for supporting the platform and helping us keep these resources freely accessible.

W2 Cleanroom Consulting

GMP cleanroom design, URS, qualification and compliance support for NHS and pharmaceutical services.

Key GDP Documents | Help Me GMP