GMP protects patients, brands, and supply chains in the UK. It also keeps UK-made medicines credible in global markets. In fact, UK biopharma companies generated £98.9 billion in turnover in 2023/2024, so quality failures quickly become expensive. MHRA sits at the center of GMP in UK compliance. The agency inspects sites, issues GMP certificates, and checks if manufacturers follow a risk-based inspection approach. In 2024/25, MHRA completed 353 GMP inspections, which shows how actively it enforces expectations.
So this article explains the UK Good Manufacturing Practices basics in plain language, and it points you to trusted PDFs.
What Is Good Manufacturing Practice in UK?
GMP in UK means you run controlled, documented, and traceable manufacturing operations. You keep products safe, consistent, and compliant across every step. You control materials, people, equipment, rooms, records, and changes.
In practical terms, UK GMP requirements push you to:
- Build a working Quality Management System (QMS)
- Document what you do, and then do what you document
- Prove you control contamination risks and mix-ups
- Investigate deviations fast, and fix root causes
- Protect data integrity, especially in computerized systems
Who Regulates GMP in UK?
MHRA regulates and enforces UK pharmaceutical GMP. It inspects manufacturers and distributors, and it checks compliance before it grants licenses. It also inspects sites periodically based on risk.
MHRA also runs the MHRA-GMDP database, which helps you verify manufacturing authorizations and GMP certificates.
Relationship Between MHRA, EU GMP, and PIC/S
MHRA aligns UK inspection practices with international standards. At the same time, UK legislation still drives the legal “must do” requirements. Meanwhile, EU GMP and PIC/S GMP provide the shared technical language many companies use.
| Topic | What it means for GMP in UK | Why it matters day-to-day |
|---|---|---|
|
MHRA |
MHRA enforces GMP through licensing, inspection, and certificates. |
You plan for MHRA inspections, respond to findings, and maintain licence compliance. |
|
EU GMP (EudraLex Vol 4) |
EU GMP remains a key reference point for GMP expectations across Europe. |
Many UK sites still structure SOPs, validation, and audits around EU GMP language. |
|
PIC/S |
MHRA participates in PIC/S, which promotes harmonised GMP standards globally. |
Align your quality system to support global inspections and partner audits. |
Guidelines and Legal Framework in the UK
UK GMP requirements sit on two pillars:
- UK law and licences (what you must comply with to manufacture and supply in the UK)
- GMP guidance (how you meet expectations in practice)
MHRA also confirms that its risk-based inspection programmes remain in place, and it continues to recognise certain inspection outcomes through mutual recognition arrangements.
Key UK GMP Regulations and Guidance Documents
Use this short list to find the right document faster:
- UK Statutory Instruments and Medicines Regulations
- EU GMP Annexes Still Applied in the UK
- MHRA Orange Guide Overview
1. UK Statutory Instruments and Medicines Regulations
UK law sets the legal conditions for manufacturing and importing medicines, including licensing expectations. The Human Medicines Regulations 2012 provide the core framework.
For a practical PDF that connects licensing to GMP expectations, MHRA also publishes “Notes for applicants and holders of a Manufacturer’s Licence.”
2. EU GMP Annexes Still Applied in the UK
Many UK companies still use EU GMP (EudraLex Volume 4) as a working standard because it supports partner audits, supply agreements, and shared terminology. The MHRA Inspectorate also describes the Orange Guide as guidance you should read alongside EU GMP standards and UK medicines legislation.
PIC/S GMP also stays relevant because MHRA participates in PIC/S, and PIC/S publishes widely used GMP guidance (PE 009).
3. MHRA Orange Guide Overview
The MHRA Orange Guide (“Rules and Guidance for Pharmaceutical Manufacturers and Distributors”) compiles UK legislation and European guidance into one reference. Teams often use it as a single “desktop” source during SOP writing, internal audits, and inspection prep.
Even if you do not buy the Orange Guide immediately, you can still use MHRA’s free PDFs to strengthen your GMP system. For example, MHRA’s GxP Data Integrity Guidance helps you set expectations for audit trails, electronic records, and trustworthy data
GMP in UK vs EU GMP: Key Differences After Brexit
Most technical GMP expectations still look similar, because companies keep aligning to EU GMP and PIC/S to support trade and shared quality language. However, Brexit created practical differences in regulatory pathways, labels, and databases.
| Area | GMP in UK (MHRA) | EU GMP (EU/EEA system) |
|---|---|---|
|
Licensing scope |
MHRA licenses medicines on a UK-wide basis from 1 Jan 2025 under Windsor Framework arrangements. |
EU uses EU procedures, including centralized authorizations for many products. |
|
Packaging rules |
UK market packs require “UK Only” labelling for UK supply, with key measures starting 1 Jan 2025. |
EU uses EU labelling rules and supply controls for EU/EEA markets. |
|
Certificates and databases |
UK uses the MHRA-GMDP database for authorisations and GMP certificates. |
EU uses EudraGMDP for EU-issued manufacturing and GMP data. |
|
Inspection reliance |
MHRA keeps a risk-based inspection approach and recognises certain EEA outcomes through mutual recognition arrangements. |
EU authorities inspect the EU framework and share outcomes via EU systems. |
Final words
UK life sciences runs on trust, and GMP in UK protects it. In 2023/24, the UK life sciences sector employed 359,600 people. It also generated £146.9 billion in turnover. So, strong GMP supports jobs, investment, and supply security.
GMP also protects the UK’s export strength. In 2024, medicinal and pharmaceutical products led UK goods exports at £41.2 billion. Therefore, weak GMP documentation can hurt revenue fast. Use official MHRA and trusted GMP PDFs for daily decisions. Then build habits that survive inspections, not just audits. Finally, Explore GMP Courses to train teams faster.
FAQ:
It means you control processes and prove consistent product quality with records.
MHRA regulates GMP and enforces it through licensing and inspections.
Use MHRA GMP/GDP hub, MHRA PDFs, EU EudraLex Volume 4, and PIC/S PE009 PDFs.
References:
Stephanie Männicke
Digital Marketing Especialist at Zamann Pharma Support, brings 8 years of experience in Corporate and Digital Communication. Specializing in Digital Marketing and Content Creation, Stephanie is currently focused on creating strategic content for Pharmuni's networks, especially content on topics such as recruitment, onboarding and employer branding. Outside of work, Stephanie is a mum, a crocheter and a movie fan. An avid reader and in search of expanding her knowledge, Stephanie is always looking for ways to innovate communication in the digital environment and connect people in a genuine way.
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