Glossary Updates12 new terms added to the glossaries · October 2, 2026, 22:44 CEST
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Glossary · GxP: good practices

Good manufacturing practice (GMP)

Also known as: GMP, EU GMP, cGMP, EU GMP guidelines

Good manufacturing practice (GMP) is the part of quality assurance that ensures medicinal products and active substances are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing or clinical trial authorization. In the EU it is laid down in Directive (EU) 2017/1572 and detailed in EudraLex Volume 4.

  • GxP
  • Pharma
  • EU
  • USA

In one sentence

GMP governs how medicinal products and active substances are manufactured and controlled. EU: EudraLex Volume 4; USA: 21 CFR Parts 210 and 211.

Example

A tablet manufacturer holds a manufacturing authorization, keeps batch records for every lot, investigates each out-of-specification result, and has a Qualified Person certify every batch before release in the EU.

How it applies

  • Legal basis: In the EU, GMP for human medicines rests on Directive 2001/83/EC and Directive (EU) 2017/1572, and for investigational medicines on Delegated Regulation (EU) 2017/1569. The PIC/S GMP guide is largely identical and used by many inspectorates outside the EU.
  • Structure of EudraLex Volume 4: Part I covers medicinal products, Part II active substances (identical in content to ICH Q7), and the annexes cover special topics such as sterile products, computerized systems and qualification and validation.
  • Quality system: GMP expects a pharmaceutical quality system with quality risk management (ICH Q9(R1)), CAPA, change control and management review, as described in ICH Q10.
  • Release: In the EU no batch reaches the market without certification by a Qualified Person.
  • Technical documentation: Specifications, manufacturing formulae, batch records, validation reports and deviation records are GMP documents under Chapter 4 and must follow good documentation practice. A revised Chapter 4 was published as a draft in July 2025; check whether the final version has been adopted.

GMP vs. GEP

GEP covers how equipment and facilities are engineered to sound technical standards. GMP covers what is manufactured with them and asks that GMP-critical aspects be qualified and validated. Good engineering is the foundation GMP qualification builds on, not a substitute for it.

Compared with the USA

The FDA's drug cGMP regulations in 21 CFR Parts 210 and 211 are binding law; the “c” for current stresses that practices must keep pace with the state of the art. US law has no counterpart to the EU Qualified Person; there, releasing batches is a responsibility of the quality control unit.