Guide
GDP vs GMP: What is the Difference?
Confused about GDP vs GMP? This guide explains the key differences based on official UK government guidance.
If you work in the pharmaceutical industry, you've likely encountered both GDP and GMP. While they sound similar and both relate to quality assurance, they apply to different stages of the medicines supply chain. Understanding the difference is essential for compliance.
What is GMP (Good Manufacturing Practice)?
According to UK government guidance, Good Manufacturing Practice (GMP) is the minimum standard that a medicines manufacturer must meet in their production processes.
Products must:
- ✓Be of consistent high quality
- ✓Be appropriate to their intended use
- ✓Meet the requirements of the marketing authorisation (MA) or product specification
GMP applies to manufacturing activities - the actual production of medicinal products.
What is GDP (Good Distribution Practice)?
Good Distribution Practice (GDP) requires that medicines are obtained from the licensed supply chain and are consistently stored, transported and handled under suitable conditions, as required by the marketing authorisation or product specification.
GDP applies to distribution activities - storage, transportation, and handling of medicines after manufacture but before reaching the patient.
Key Difference at a Glance
GMP = Manufacturing
Making the product
GDP = Distribution
Storing, transporting, handling
Who Needs GDP or GMP?
According to MHRA guidance, organisations that may have to comply with GMP and/or GDP include:
- ✓Manufacturer licence holders
- ✓Wholesale dealer licence (WDA(H)) holders
- ✓Blood establishment authorisation holders
- ✓Non-UK sites employed by UK MA holders
Inspection Requirements
The MHRA carries out inspections to check if manufacturing and distribution sites comply with GMP or GDP. According to gov.uk:
- ✓You will be inspected when you apply for a manufacturer or wholesaler dealer licence
- ✓After initial inspection, sites are re-inspected periodically based on risk assessments
- ✓Overseas manufacturing sites are also inspected
What Happens During an Inspection?
MHRA inspectors examine systems used to manufacture and/or distribute medicines. This includes:
Common Deficiencies
During inspections, deficiencies are graded at 3 levels:
Critical Deficiency
Has produced or significantly risks producing a product which is harmful to patients, or could result in a harmful residue in a food-producing animal.
Major Deficiency
Has or may produce a product that does not comply with its marketing authorisation, or indicates a major deviation from GMP/GDP.
Other Deficiency
Cannot be classified as critical or major, but indicates a departure from good manufacturing or distribution practice.
Need Help with GDP or GMP Compliance?
Whether you need support with GDP compliance for your wholesale distribution activities or GMP preparation for manufacturing, I can help with:
- GDP compliance audits and preparation
- GDP training for your team
- WDA(H) application support
- QMS development and documentation
- Pre-inspection readiness