In detail
The main areas and their basis
- GMP (Good Manufacturing Practice): the EU GMP Guide, EudraLex Volume 4. In Germany, § 3 of the German Ordinance on the Manufacture of Medicinal Products and Active Substances (AMWHV) refers to Part I of the Guide for medicinal products, Part II for active substances and Part IV for advanced therapy medicinal products when interpreting good manufacturing practice.
- GDP (Good Distribution Practice): the Commission guidelines on good distribution practice of medicinal products for human use, applicable since 24 November 2013, and separate guidelines for active substances of 19 March 2015.
- GCP (Good Clinical Practice): under Article 47 of Regulation (EU) No 536/2014, clinical trials must be conducted in accordance with the principles of good clinical practice, taking account of ICH guideline E6. Its revision E6(R3), with its principles and Annex 1, has applied in the EU since 23 July 2025.
- GLP (Good Laboratory Practice): applies to non-clinical health and environmental safety studies whose results are assessed in authorisation and similar procedures; in Germany under § 19a of the German Chemicals Act (ChemG) and its Annex 1.
- GVP (Good Pharmacovigilance Practices): EMA guidance that applies to marketing authorisation holders, EMA and the national authorities.
Why the distinction matters
The areas have different legal bases and scopes. A laboratory testing medicinal products and starting materials for release works under GMP. GLP, by contrast, concerns non-clinical safety studies and is demonstrated by a separate GLP certificate. Mixing up the terms risks setting the wrong requirements in contracts, audits and supplier qualification.
Common principles
Despite the different sets of rules, the GxP areas require comparable elements: a documented quality management system, written procedures (SOPs), trained staff, suitable premises and equipment, and independent quality assurance or self-inspection. Companies active in several areas often combine these elements in a single quality management system with area-specific additions.
Common weaknesses
- Interfaces between manufacturing and distribution, for example when transport conditions are not set out in contracts.
- Service providers that have not been qualified against the rules relevant to their activity.
- Gaps in documentation that come to light during audits or inspections.
In practice at A&O Pharma
A&O Pharma's strategic GxP consulting covers GxP audits, support during regulatory inspections, qualification of equipment and premises from DQ to PQ, and process and cleaning validation. In day-to-day operations, A&O Pharma can take on deviations, CAPA, change control, complaints and self-inspections on request.
GMP and GxP Consulting & QA SupportFrequently asked questions
What does the x in GxP stand for?
For the respective area: M for manufacturing, D for distribution, C for clinical, L for laboratory and V for vigilance, meaning pharmacovigilance. GxP groups these sets of rules under one term.
Is a GMP laboratory automatically a GLP laboratory?
No. GMP applies to testing medicinal products and starting materials as part of manufacturing, GLP to non-clinical safety studies. Under the German Chemicals Act, GLP requires a separate certificate.
Is GxP a legal requirement?
Not as a collective term, but the individual practices are: GMP for example through the AMWHV, GLP through § 19a of the German Chemicals Act and GCP through Article 47 of Regulation (EU) No 536/2014.
