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The terms that matter.

23 Technical terms from GMP, regulatory affairs and analytical testing, explained by the people who work with them every day. No marketing copy, just what Annex 16, iMAH or IMPD really mean in practice.

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§ 14 AMG

in-house Qualified Persons

§ 14 AMWHV

GMP-compliant quality control

Glossary

Technical terms, clearly explained.

GMP 10 General 1 Quality 5 Analytical testing 5 Regulatory 2

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GMP

AMWHV The AMWHV (German Ordinance on the Manufacture of Medicinal Products and Active Substances) is the German operating ordinance for the manufacture, testing, storage and import of medicinal products and active substances. It requires Good Manufacturing Practice and defines the duties of the Head of Production and the Head of Quality Control. More about AMWHV

Annex 16 Annex 16 of the EU GMP Guide (EudraLex Volume 4) sets out how a Qualified Person (QP) certifies batches before they are placed on the EU market or exported. The current version has applied since 15 April 2016, and its principles apply accordingly to investigational medicinal products. More about Annex 16

Clinical Trials Regulation (EU) No 536/2014 (CTR) Regulation (EU) No 536/2014, the Clinical Trials Regulation (CTR), governs the authorisation and conduct of clinical trials on medicinal products for human use in the EU. It has applied since 31 January 2022, repealed Directive 2001/20/EC and also covers manufacture, QP certification and labelling of trial medication. More about Clinical Trials Regulation (EU) No 536/2014 (CTR)

Good Manufacturing Practice (GMP) Good Manufacturing Practice (GMP) is the part of quality assurance which ensures that medicinal products are consistently produced, imported and controlled to the quality standards appropriate to their intended use. This is how Directive (EU) 2017/1572 defines it. More about GMP

Manufacturing and Import Authorisation (MIA) A manufacturing and import authorisation (MIA) is the official permission to manufacture medicinal products or to import them into the EU from third countries. In Germany it corresponds to the manufacturing authorisation under § 13 AMG and, for imports from outside the EU/EEA, the import authorisation under § 72 AMG. More about MIA

Qualified Person (QP) The Qualified Person (QP), in Germany the Sachkundige Person under § 14 AMG, is responsible for ensuring that every batch of a medicinal product has been manufactured and tested in line with the applicable rules. The QP certifies this in a register before the batch is placed on the market. More about QP

Site Master File (SMF) A Site Master File is a document prepared by the manufacturer that describes the GMP-related activities of a site: quality system, personnel, premises, equipment, production, quality control and distribution. Authorities use it to plan and prepare GMP inspections. More about SMF

§ 13 AMG § 13 AMG governs the manufacturing authorisation: anyone who manufactures medicinal products, certain active substances or other substances of human origin intended for manufacture on a commercial or professional basis needs an authorisation from the competent authority. This also applies to testing on which batch release is based. More about § 13 AMG

§ 14 AMG § 14 AMG sets out an exhaustive list of grounds on which the authority may refuse a manufacturing authorisation under § 13 AMG. The most important ground is the absence of a person with the expertise required by § 15 AMG who is responsible for the duties under § 19 AMG. This is where the term Qualified Person under § 14 AMG comes from. More about § 14 AMG

§ 15 AMG § 15 AMG sets out how the expertise of a Qualified Person under § 14 AMG is demonstrated: by a licence to practise as a pharmacist (Approbation) or a degree of at least four years in specified subjects, in each case combined with at least two years of practical experience in the quality testing of medicinal products. More about § 15 AMG

General

Licence to Practise (Approbation) The Approbation is the state licence to practise as a pharmacist in Germany. For a Qualified Person under § 14 AMG, it is one of two educational routes set out in § 15 AMG. Either way, at least two years of practical experience in the quality testing of medicinal products are also required. More about Licence to Practise (Approbation)

Quality

Corrective and Preventive Action (CAPA) CAPA stands for corrective and preventive action. A corrective action eliminates the cause of a detected non-conformity to prevent recurrence, a preventive action eliminates the cause of a potential one before it occurs. The CAPA system is a core element of the pharmaceutical quality system under ICH Q10. More about CAPA

Good Distribution Practice (GDP) Good Distribution Practice (GDP) governs the wholesale distribution of medicinal products: procurement, holding, supply and export. It ensures that the quality and integrity of medicines are maintained throughout the supply chain and that falsified medicines do not enter the legal supply chain. More about GDP

GxP GxP is a collective term for the good practices in the pharmaceutical sector, such as GMP for manufacturing, GDP for distribution, GCP for clinical trials, GLP for non-clinical safety studies and GVP for pharmacovigilance. The binding requirements are set out in the individual rules for each area. More about GxP

Out of Specification (OOS) An OOS result is a test result that falls outside the established specification or acceptance criteria. Under EU GMP, it must be investigated according to a defined procedure. Confirmed OOS results affecting batches already on the market must be reported to the competent authority. More about OOS

Product Quality Review (PQR) The Product Quality Review is a regular, normally annual quality review of every authorised medicinal product under Chapter 1 of the EU GMP Guide. It verifies process consistency and the appropriateness of specifications, highlights trends and identifies improvements to product and process. More about PQR

Analytical testing

ICH Q2(R2) ICH Q2(R2) is the international guideline on the validation of analytical procedures. It sets out how to demonstrate that a test method is fit for its intended purpose, for example through specificity, range, accuracy and precision. EMA has applied it since 14 June 2024. More about ICH Q2(R2)

LC-MS/MS LC-MS/MS couples liquid chromatography with tandem mass spectrometry. Chromatography separates the sample, then two mass filters selectively detect the target substance and a characteristic fragment. This makes it possible to determine traces such as nitrosamines with high selectivity and sensitivity. More about LC-MS/MS

Nitrosamines Nitrosamines are impurities classified as probable human carcinogens. Since their discovery in sartans in 2018, marketing authorisation holders in the EU must assess the risk for every human medicine and keep nitrosamines below a substance-specific limit. More about Nitrosamines

Ph. Eur. The European Pharmacopoeia (Ph. Eur.) is a collection of common quality standards for medicines, their components and containers. It is based on a Council of Europe convention of 1964 and, in Germany, forms part of the pharmacopoeia under § 55 of the German Medicinal Products Act (AMG). More about Ph. Eur.

Stability Study A stability study shows how the quality of an active substance or medicinal product changes over time under the influence of temperature, humidity and light. The data are used to set the shelf life or re-test period and the storage conditions. The key reference is the ICH guideline Q1A(R2). More about Stability Study

Regulatory

Interim Marketing Authorisation Holder (iMAH) An interim marketing authorisation holder (iMAH) is a company that holds the marketing authorisation for a medicinal product on behalf of another company for a transitional period, for example until it is transferred to a commercial partner. This matters above all for companies based outside the EEA, because the marketing authorisation holder must be established in the EEA. More about iMAH

Investigational Medicinal Product Dossier (IMPD) The Investigational Medicinal Product Dossier (IMPD) is part of the application for authorisation of a clinical trial in the EU. It describes the quality, manufacture and control of the investigational medicinal product and summarises non-clinical data and previous clinical experience. More about IMPD

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