Help Me GxP

Help Me GxP

Knowledge Hub

Help Me GxP

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 OF HELP ME GxP

INDEPENDENT PHARMACEUTICAL QUALITY & CLEANROOM CONSULTANCY

Planning a regulated facility, resolving a GMP/GDP issue or preparing for inspection?

W2 supports pharmaceutical manufacturers, wholesale distributors and NHS aseptic services with URS development and independent review, design and qualification support, GMP/GDP audits, remediation, and QP, RP and RPi services.

Specialist support

  • URS development & independent review
  • Design review, DQ & qualification support
  • GMP/GDP audits, PQS & remediation
  • QP, RP & RPi services

W2 sponsors Help Me GxP, helping keep its practical GxP resources free to use.

Key GDP Documents | Help Me GxP