{"id":7017,"date":"2026-04-01T11:17:13","date_gmt":"2026-04-01T09:17:13","guid":{"rendered":"https:\/\/mediconomics.com\/?post_type=glossary&#038;p=7017"},"modified":"2026-07-13T19:10:02","modified_gmt":"2026-07-13T17:10:02","slug":"good-manufacturing-practice-gmp","status":"publish","type":"glossary","link":"https:\/\/mediconomics.com\/en\/glossar\/good-manufacturing-practice-gmp\/","title":{"rendered":"Good Manufacturing Practice (GMP)"},"content":{"rendered":"<p>Good Manufacturing Practice (GMP), also known as &#8220;Gute Herstellungspraxis&#8221; in German, refers to binding quality requirements for the manufacture and testing of medicinal products and active substances. The aim is to ensure that products are consistently manufactured to the required quality and are safe for patients. GMP is therefore a central pillar along the entire supply chain \u2013 from raw materials and active pharmaceutical ingredients (APIs) through production to batch release by the Qualified Person. Consistent compliance with GMP not only protects patients but also safeguards a product&#8217;s approvability and marketability.<\/p>\n<h2>What does GMP specifically cover?<\/h2>\n<p>GMP is not a single document but a comprehensive body of requirements covering processes, personnel, premises, equipment and documentation. Typical GMP core elements include:<\/p>\n<ul>\n<li><strong>Quality Management System (QMS):<\/strong> roles, responsibilities, CAPA processes (Corrective and Preventive Actions), change control and continuous improvement.<\/li>\n<li><strong>Documentation and data integrity:<\/strong> manufacturing instructions, test plans, batch documentation and complete, traceable records in accordance with the ALCOA+ principles.<\/li>\n<li><strong>Validation and qualification:<\/strong> evidence that processes, facilities and systems reproducibly deliver suitable results (e.g. process, cleaning and computer validation).<\/li>\n<li><strong>Supplier qualification:<\/strong> assessment and monitoring of suppliers of critical materials and services.<\/li>\n<li><strong>Deviation management and OOS\/OOT:<\/strong> systematic investigation of deviations, out-of-specification and out-of-trend results with root cause analysis and CAPA.<\/li>\n<li><strong>Training and personnel qualification:<\/strong> ensuring that all personnel involved are adequately qualified and trained for their tasks.<\/li>\n<\/ul>\n<h2>GMP in the EU context: legal framework and guidelines<\/h2>\n<p>In Europe, GMP is set out in EU law and the EU GMP Guide (EudraLex, Volume 4), which is applied by authorities such as the EMA and national inspectorates (e.g. the German Federal Institute for Drugs and Medical Devices, BfArM, and the Paul-Ehrlich-Institut, PEI). For manufacturers, regular GMP inspections are a key oversight instrument and can be conducted unannounced.<\/p>\n<p>GMP requirements are closely linked to marketing authorisation dossiers, as manufacturing processes and quality controls form a central part of the CMC documentation (Chemistry, Manufacturing and Controls) in the eCTD. Changes to manufacturing processes must therefore be assessed in coordination with Regulatory Affairs and, where applicable, notified to or approved by the authorities. In practice, this close interplay between GMP and RA is a key success factor for smooth authorisation procedures.<\/p>\n<p>For international manufacturers supplying the EU market, the principle of mutual recognition of GMP inspections (Mutual Recognition Agreements, MRAs), which the EU has concluded with various third countries, also applies. Nevertheless, EU authorities reserve the right to conduct their own inspections \u2013 particularly for cause or at new manufacturing sites.<\/p>\n<h2>IMP, trial supply logistics and the QP function<\/h2>\n<p>GMP also plays a decisive role in clinical trials: Investigational Medicinal Products (IMP) must be manufactured, packaged, labelled and released under suitable GMP conditions. The requirements for IMPs are set out in Annex 13 of the EU GMP Guide and differ in some respects from those for commercial products \u2013 particularly regarding flexibility in batch sizes and specifications during early development phases.<\/p>\n<p>Changes to manufacturing or packaging can have regulatory consequences for an ongoing clinical trial and often need to be assessed by Regulatory Affairs and reported in CTIS (under CTR 536\/2014). In a study start-up, the interfaces between production, quality control, investigational site logistics and clinical project management are therefore particularly critical. Missing or delayed IMP deliveries can block the entire conduct of a trial.<\/p>\n<p>In the EU, a batch of a medicinal product may generally only be placed on the market or made available for a clinical trial once a Qualified Person (QP) has confirmed that it has been manufactured and tested in accordance with GMP and the marketing authorisation or Clinical Trial Authorisation. The QP&#8217;s responsibility is enshrined in EU Directive 2001\/83\/EC and EU GMP legislation.<\/p>\n<p>QP certification includes assessment of the batch documentation, recording of deviations, analytical results (Certificate of Analysis, CoA) and compliance with the approved manufacturing process. Additional requirements apply to imported batches from third countries: every imported batch must be released by a QP in the EU unless a valid MRA is in place. This requirement poses a considerable organisational challenge, particularly for global supply chains.<\/p>\n<p>The QP bears personal responsibility and must not be pressured into releasing batches that do not meet requirements. A robust, independent QP function is therefore a hallmark of good GMP culture within a pharmaceutical company.<\/p>\n<h2>GMP, data integrity and audit readiness<\/h2>\n<p>Modern inspections place great emphasis on data integrity, traceability and effective quality systems. The ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, as well as complete, consistent, enduring, available) define the minimum requirements for GMP-relevant data and records. Common weaknesses include inadequate change control, unclear responsibilities, incomplete training documentation or CAPA processes that lack robustness.<\/p>\n<p>Companies should regard GMP readiness as an ongoing state, supported by internal audits, mock inspections and clear Standard Operating Procedures (SOPs). Critical GMP findings in regulatory inspections can lead to suspension of the manufacturing licence or market withdrawal, with immediate consequences for patient supply and company value.<\/p>\n<h2>Frequently Asked Questions (FAQ)<\/h2>\n<h3>Does GMP also apply to active substances (APIs)?<\/h3>\n<p>Yes. Specific GMP requirements apply to active substances, as set out in the ICH Q7 Guideline &#8220;Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients&#8221; and in Part II of the EU GMP Guide. The quality of the active substance is directly decisive for the safety and efficacy of the finished medicinal product \u2013 quality defects in the API can render the entire product unusable.<\/p>\n<h3>What is the difference between GMP and GCP?<\/h3>\n<p>GMP governs the manufacture and quality control of medicinal products and active substances, ensuring that products are manufactured to consistent quality. Good Clinical Practice (GCP) under ICH E6(R3) governs the planning, conduct, documentation and reporting of clinical trials in humans. Both are GxP standards addressing different phases of the product lifecycle \u2013 but they overlap in clinical trials, where the IMP is subject to both GMP and GCP requirements.<\/p>\n<h3>Why is documentation so important under GMP?<\/h3>\n<p>Because quality and compliance can only be demonstrated if processes and results are fully, correctly and traceably documented. The guiding principle is: &#8220;If it isn&#8217;t documented, it wasn&#8217;t done.&#8221; Gaps or retrospective entries in GMP documentation are a common starting point for critical findings in inspections and can invalidate entire batches.<\/p>\n<h2>Regulatory references<\/h2>\n<ul>\n<li>EU GMP Guide (EudraLex, Volume 4) incl. Annex 13 (Investigational Medicinal Products)<\/li>\n<li>ICH Q7: GMP Guide for Active Pharmaceutical Ingredients<\/li>\n<li>ICH Q10: Pharmaceutical Quality System<\/li>\n<li>ICH E6(R3) Guideline for Good Clinical Practice<\/li>\n<li>EU Directive 2001\/83\/EC (Community code relating to medicinal products for human use)<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Good Manufacturing Practice (GMP), also known as &#8220;Gute Herstellungspraxis&#8221; in German, refers to binding quality requirements for the manufacture and testing of medicinal products and active substances. The aim is to ensure that products are consistently manufactured to the required quality and are safe for patients. GMP is therefore a central pillar along the entire [&hellip;]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"glossary-cat":[],"class_list":["post-7017","glossary","type-glossary","status-publish","hentry"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/7017","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/glossary"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/10"}],"version-history":[{"count":1,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/7017\/revisions"}],"predecessor-version":[{"id":7019,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/7017\/revisions\/7019"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=7017"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=7017"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}