{"id":4552,"date":"2026-10-07T19:38:41","date_gmt":"2026-10-07T19:38:41","guid":{"rendered":"https:\/\/nano-test.de\/?p=4552"},"modified":"2026-10-07T19:39:19","modified_gmt":"2026-10-07T19:39:19","slug":"tests-zur-markteinfuehrung-von-arzneimitteln","status":"publish","type":"post","link":"https:\/\/nano-test.de\/en\/2026\/10\/07\/tests-zur-markteinfuehrung-von-arzneimitteln\/","title":{"rendered":"Tests for the market launch of drugs"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"4552\" class=\"elementor elementor-4552\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-58c25262 ts-col-stretched-none ts-bg-color-over-image elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"58c25262\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-8b96c43 ts-bg-color-over-image\" data-id=\"8b96c43\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d457181 elementor-widget elementor-widget-text-editor\" data-id=\"d457181\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h1><span style=\"color: #000000;\">Drug market approval tests: The qualitative basis of the approval process<\/span><\/h1><p><span style=\"color: #000000;\">The development of a drug includes years of research and development work as well as preclinical and clinical studies. But even when all this work is completed, the last and decisive phase follows before the drug can be brought onto the market: the . In this process, the quality, safety and efficacy data submitted to the regulatory authorities must be fully verifiable and in line with international standards.<\/span><\/p><p><span style=\"color: #000000;\"><strong>Die Tests zur Markteinf\u00fchrung von Arzneimitteln<\/strong> bilden die Grundlage des Qualit\u00e4tsabschnitts dieses Dokuments. Diese Tests, die in der T\u00fcrkei von der T\u0130TCK (T\u00fcrkische Arzneimittel- und Medizinproduktebeh\u00f6rde), in Europa von der EMA (Europ\u00e4ische Arzneimittelagentur) und in den USA von der FDA (Food and Drug Administration) gefordert werden, belegen die Identit\u00e4t, Reinheit, Wirksamkeit, Stabilit\u00e4t und biologische Wirksamkeit des Arzneimittels. Die Durchf\u00fchrung der Pr\u00fcfungen gem\u00e4\u00df den Grunds\u00e4tzen der GLP (Gute Laborpraxis) und der GMP (Gute Herstellungspraxis) ist f\u00fcr die Annahme des Zulassungsantrags zwingend erforderlich.<\/span><\/p><p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift --><\/span><\/p><h2><span style=\"color: #000000;\">The Joint Technical Dossier (CTD) in the approval process<\/span><\/h2><p><span style=\"color: #000000;\">Zulassungsantr\u00e4ge f\u00fcr Arzneimittel werden im Rahmen der internationalen Harmonisierung im <strong>CTD-Format (Common Technical Document)<\/strong> erstellt. Das CTD besteht aus f\u00fcnf Modulen, wobei die Qualit\u00e4tsdaten in Modul 3 (Quality) enthalten sind. Die Marktzulassungstests bilden direkt den Inhalt dieses Moduls:<\/span><\/p><ul><li><span style=\"color: #000000;\"><strong>Modul 1:<\/strong> Administrative Angaben und regionale Anforderungen<\/span><\/li><li><span style=\"color: #000000;\"><strong>Modul 2:<\/strong> Zusammenfassungen zu Qualit\u00e4t, Sicherheit und Wirksamkeit (QOS, Nonclinical, Clinical)<\/span><\/li><li><span style=\"color: #000000;\"><strong>Modul 3:<\/strong> Qualit\u00e4t (chemische, pharmazeutische und biologische Daten)<\/span><\/li><li><span style=\"color: #000000;\"><strong>Modul 4:<\/strong> Berichte \u00fcber vorklinische Studien<\/span><\/li><li><span style=\"color: #000000;\"><strong>Modul 5:<\/strong> Berichte \u00fcber klinische Studien<\/span><\/li><\/ul><p><span style=\"color: #000000;\">The test data presented under Module 3 are prepared separately for the pharmaceutical active ingredient (API) and the finished medicinal product. These data must comply with the ICH guidelines (Q1-Q14).<\/span><\/p><p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift --><\/span><\/p><h2><span style=\"color: #000000;\">Main categories of market approval tests<\/span><\/h2><p><span style=\"color: #000000;\">The tests required for the approval of a medicinal product can be divided into the following main categories:<\/span><\/p><p><span style=\"color: #000000;\"><!-- H3-Unter&#252;berschrift --><\/span><\/p><h3><span style=\"color: #000000;\">1. Identity and Purity Checks<\/span><\/h3><p><span style=\"color: #000000;\">They prove that the drug is the active ingredient indicated and that it has an acceptable degree of purity. They are carried out according to the ICH guidelines Q3A, Q3B, Q3C and Q3D.<\/span><\/p><ul><li><span style=\"color: #000000;\"><strong>Identit\u00e4t (Identity):<\/strong> Best\u00e4tigung des Wirkstoffs (API) mittels FTIR, HPLC und NMR<\/span><\/li><li><span style=\"color: #000000;\"><strong>Contamination profile:<\/strong> Organic impurities, solvent residues, heavy metals<\/span><\/li><li><span style=\"color: #000000;\"><strong>Enantiomere Reinheit:<\/strong> Verh\u00e4ltnis der optischen Isomere mittels chiraler HPLC<\/span><\/li><\/ul><p><span style=\"color: #000000;\"><!-- H3-Unter&#252;berschrift --><\/span><\/p><h3><span style=\"color: #000000;\">2. Salary determination and salary uniformity<\/span><\/h3><p><span style=\"color: #000000;\">Verification of the active substance content of the product and the consistency between the individual doses.<\/span><\/p><ul><li><span style=\"color: #000000;\"><strong>Assay (Gehaltsbestimmung):<\/strong> Bestimmung des API-Gehalts mittels HPLC<\/span><\/li><li><span style=\"color: #000000;\"><strong>Gehaltsgleichm\u00e4\u00dfigkeit (Content Uniformity):<\/strong> Gem\u00e4\u00df den Anforderungen der Pharmakop\u00f6e<\/span><\/li><li><span style=\"color: #000000;\"><strong>Aufl\u00f6sungsgeschwindigkeit (Dissolution):<\/strong> F\u00fcr feste orale Darreichungsformen<\/span><\/li><\/ul><p><span style=\"color: #000000;\"><!-- H3-Unter&#252;berschrift --><\/span><\/p><h3><span style=\"color: #000000;\">3. Stability Tests (I Q1)<\/span><\/h3><p><span style=\"color: #000000;\">Proof that the product maintains its quality over the entire shelf life.<\/span><\/p><ul><li><span style=\"color: #000000;\"><strong>Langzeitstabilit\u00e4t:<\/strong> 25 \u00b0C\/60 % r. F. oder 30 \u00b0C\/65 % r. F.<\/span><\/li><li><span style=\"color: #000000;\"><strong>Beschleunigte Stabilit\u00e4t:<\/strong> 40 \u00b0C\/75 % r. F.<\/span><\/li><li><span style=\"color: #000000;\"><strong>Zwischenstabilit\u00e4t:<\/strong> 30 \u00b0C\/65 % r. F.<\/span><\/li><li><span style=\"color: #000000;\"><strong>Light stability:<\/strong> I Q1B compliant light exposure<\/span><\/li><\/ul><p><span style=\"color: #000000;\"><!-- H3-Unter&#252;berschrift --><\/span><\/p><h3><span style=\"color: #000000;\">4. Bioavailability and Bioequivalence (I M13A)<\/span><\/h3><p><span style=\"color: #000000;\">Detects the equivalence of generics to the reference preparation.<\/span><\/p><ul><li><span style=\"color: #000000;\"><strong>Validierung bioanalytischer Methoden:<\/strong> Plasmaanalyse mittels LC-MS\/MS<\/span><\/li><li><span style=\"color: #000000;\"><strong>Pharmakokinetische Parameter:<\/strong> Cmax, AUC, Tmax<\/span><\/li><li><span style=\"color: #000000;\"><strong>Statistische \u00c4quivalenz:<\/strong> 80\u2013125 %-Kriterium bei einem 90 %-Konfidenzintervall<\/span><\/li><\/ul><p><span style=\"color: #000000;\"><!-- H3-Unter&#252;berschrift --><\/span><\/p><h3><span style=\"color: #000000;\">5. Microbiological Quality Tests<\/span><\/h3><p><span style=\"color: #000000;\">Are carried out for sterile products and products for which microbiological limit values are prescribed.<\/span><\/p><ul><li><span style=\"color: #000000;\"><strong>Sterility test:<\/strong> Pharmakop\u00f6e-konform<\/span><\/li><li><span style=\"color: #000000;\"><strong>Test auf mikrobiologische Grenzwerte:<\/strong> TAMC, TYMC und Nachweis von Krankheitserregern<\/span><\/li><li><span style=\"color: #000000;\"><strong>Endotoxintest:<\/strong> LAL-Methode<\/span><\/li><\/ul><p><span style=\"color: #000000;\"><!-- Tabellenanfang --><\/span><\/p><h2><span style=\"color: #000000;\">Summary of tests for market launch and related guidelines<\/span><\/h2><p><span style=\"color: #000000;\">The following table summarizes the basic tests required by the drug approval process and the associated ICH guidelines:<\/span><\/p><table><thead><tr><th><span style=\"color: #000000;\">Test category<\/span><\/th><th><span style=\"color: #000000;\">Related ego guideline<\/span><\/th><th><span style=\"color: #000000;\">Evaluated Parameter<\/span><\/th><th><span style=\"color: #000000;\">CTD module<\/span><\/th><\/tr><\/thead><tbody><tr><td><span style=\"color: #000000;\"><strong>Identity and purity<\/strong><\/span><\/td><td><span style=\"color: #000000;\">I Q2A, Q3B, Q3C, Q3D, Q6A<\/span><\/td><td><span style=\"color: #000000;\">Identity of the active ingredient, contamination profile, heavy metals<\/span><\/td><td><span style=\"color: #000000;\">Module 3.2.s<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Quantitative Determination<\/strong><\/span><\/td><td><span style=\"color: #000000;\">I Q2(R2), Q6A<\/span><\/td><td><span style=\"color: #000000;\">API salary, uniformity of salary, solubility<\/span><\/td><td><span style=\"color: #000000;\">Module 3.2.p<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Stability<\/strong><\/span><\/td><td><span style=\"color: #000000;\">I Q1A(R2), Q1B, Q1E<\/span><\/td><td><span style=\"color: #000000;\">Durability, degradation profile, light stability<\/span><\/td><td><span style=\"color: #000000;\">Module 3.2.S.7 \/ 3.2.P.8<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Bioequivalence<\/strong><\/span><\/td><td><span style=\"color: #000000;\">I M13A, E6(R2)<\/span><\/td><td><span style=\"color: #000000;\">Cmax, AUC, Tmax, statistical equivalence<\/span><\/td><td><span style=\"color: #000000;\">Module 5.3.1<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Microbiological quality<\/strong><\/span><\/td><td><span style=\"color: #000000;\">I Q6A, Q4B<\/span><\/td><td><span style=\"color: #000000;\">Sterility, Microbiological Limits, Endotoxins<\/span><\/td><td><span style=\"color: #000000;\">Module 3.2.p.3<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\"><strong>Analytical Validation<\/strong><\/span><\/td><td><span style=\"color: #000000;\">I Q2(R2), Q14<\/span><\/td><td><span style=\"color: #000000;\">Accuracy, Accuracy, Specificity, Lod\/Loq<\/span><\/td><td><span style=\"color: #000000;\">Module 3.2.S.4 \/ 3.2.P.5<\/span><\/td><\/tr><\/tbody><\/table><p><span style=\"color: #000000;\"><!-- Ende der Tabelle --><\/span><\/p><p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift --><\/span><\/p><h2><span style=\"color: #000000;\">The role of GLP and GMP in the approval process<\/span><\/h2><p><span style=\"color: #000000;\">The validity of market approval tests depends not only on the use of correct analytical methods, but also on the fact that these tests are carried out in accredited laboratories and according to the GLP principles. GLP sets strict rules in areas such as personnel training, device calibration, standard work instructions (SOP), data integrity, and audit trail (Audit Trail).<\/span><\/p><p><span style=\"color: #000000;\">Likewise, the GMP conformity of the manufacturing process is an inseparable part of the application for approval. The simultaneous compliance with GLP and GMP proves that the drug has a consistent quality, both in the laboratory and on the production scale.<\/span><\/p><div class=\"note\"><span style=\"color: #000000;\"><strong>Wichtig:<\/strong> Die in Ihrem Zulassungsantrag vorgelegten Pr\u00fcfberichte m\u00fcssen bei Inspektionen durch die Zulassungsbeh\u00f6rden vertretbar sein. Daher ist es von entscheidender Bedeutung, dass die Pr\u00fcfungen in GLP-zertifizierten Laboren durchgef\u00fchrt und die Berichte gem\u00e4\u00df den ALCOA+-Prinzipien erstellt werden.<\/span><\/div><p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift: Nano-Test --><\/span><\/p><h2><span style=\"color: #000000;\">GLP-compliant solutions for market approval tests with nano-test<\/span><\/h2><p><span style=\"color: #000000;\">Der Zulassungsprozess f\u00fcr Arzneimittelhersteller erfordert eine intensive Datenaufbereitung und sorgf\u00e4ltige analytische Arbeit. <strong>Nano-Test<\/strong> ist ein GLP-akkreditierter L\u00f6sungspartner, der alle in diesem Prozess ben\u00f6tigten Qualit\u00e4tspr\u00fcfungen aus einer Hand anbietet.<\/span><\/p><div class=\"highlight\"><h3><span style=\"color: #000000;\">Nano-Test \u2013 Performance Description<\/span><\/h3><p><span style=\"color: #000000;\">Nano-Test f\u00fchrt <strong>alle<\/strong> f\u00fcr den Markteinf\u00fchrungsprozess von Arzneimitteln erforderlichen Qualit\u00e4tspr\u00fcfungen in seinen GLP- und ISO\/IEC 17025-akkreditierten Laboren durch. Unser Leistungsportfolio:<\/span><\/p><ul><li><span style=\"color: #000000;\"><strong>Identit\u00e4ts- und Reinheitspr\u00fcfungen:<\/strong> API-Verifizierung und Erstellung von Verunreinigungsprofilen mittels FTIR, HPLC-DAD, LC-MS\/MS, GC-MS\/MS und ICP-MS.<\/span><\/li><li><span style=\"color: #000000;\"><strong>Quantitative Bestimmung und Gehaltseinheitlichkeit:<\/strong> Assay-, Gehaltseinheitlichkeits- und Aufl\u00f6sungspr\u00fcfungen gem\u00e4\u00df den Monografien der Pharmakop\u00f6en.<\/span><\/li><li><span style=\"color: #000000;\"><strong>Stabilit\u00e4tspr\u00fcfungen:<\/strong> Langzeit-, beschleunigte und Zwischenstabilit\u00e4tsstudien gem\u00e4\u00df ICH Q1A(R2); Photostabilit\u00e4tspr\u00fcfungen gem\u00e4\u00df ICH Q1B.<\/span><\/li><li><span style=\"color: #000000;\"><strong>Bioanalytik und Bio\u00e4quivalenz:<\/strong> Analyse von Plasmaproben mittels LC-MS\/MS, Berechnung pharmakokinetischer Parameter und statistische Bewertung der Bio\u00e4quivalenz.<\/span><\/li><li><span style=\"color: #000000;\"><strong>Microbiological quality:<\/strong> Sterilit\u00e4tstests, Tests zur Bestimmung der mikrobiellen Grenzwerte, Endotoxin-Tests (LAL) und Tests zur Wirksamkeit von Konservierungsstoffen.<\/span><\/li><li><span style=\"color: #000000;\"><strong>Analytical Validation:<\/strong> Methodenentwicklung, Validierung und Transfer gem\u00e4\u00df ICH Q2(R2) und Q14.<\/span><\/li><\/ul><p><span style=\"color: #000000;\">Alle unsere Arbeiten werden in Form von Berichten im CTD-Format vorgelegt. Die Datenintegrit\u00e4t (ALCOA+-Prinzipien) wird gew\u00e4hrleistet und ist bei Inspektionen durch die Zulassungsbeh\u00f6rden vertretbar. <strong>Es werden GLP-Konformit\u00e4tsberichte<\/strong> erstellt.<\/span><\/p><\/div><h3><span style=\"color: #000000;\">Advantages of nano-test in market launch tests:<\/span><\/h3><ul><li><span style=\"color: #000000;\"><strong>L\u00f6sung aus einer Hand:<\/strong> Alle Identit\u00e4ts-, Reinheits-, Stabilit\u00e4ts-, bioanalytischen und mikrobiologischen Pr\u00fcfungen unter einem Dach.<\/span><\/li><li><span style=\"color: #000000;\"><strong>CTD-konforme Berichterstattung:<\/strong> Berichte, die den Anforderungen von Modul 3 und Modul 5 entsprechen und von den Zulassungsbeh\u00f6rden akzeptiert werden.<\/span><\/li><li><span style=\"color: #000000;\"><strong>Verfolgung aktueller Rechtsvorschriften:<\/strong> Sofortige Anpassung an neu ver\u00f6ffentlichte Leitlinien wie ICH Q14.<\/span><\/li><li><span style=\"color: #000000;\"><strong>Hochmoderne technologische Infrastruktur:<\/strong> LC-MS\/MS, GC-MS\/MS, ICP-MS, HPLC-DAD und Klimakammern.<\/span><\/li><li><span style=\"color: #000000;\"><strong>Fachpersonal:<\/strong> Ein Team mit Erfahrung in den Bereichen pharmazeutische Analytik, Bioanalytik, Validierung und Zulassung.<\/span><\/li><li><span style=\"color: #000000;\"><strong>Schnelle Berichterstellung:<\/strong> Ergebnislieferung innerhalb von 5\u201310 Werktagen bei Standardanalysen.<\/span><\/li><\/ul><p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift: Ergebnis --><\/span><\/p><p><span style=\"color: #000000;\">The market launch of drugs requires the successful completion of a comprehensive and careful test procedure. Identity, purity, salary, stability, bioequivalence and microbiological quality checks provide scientific evidence of the safety, efficacy and quality of the drug. The performance of these tests in accredited laboratories in accordance with the GLP principles and the complete reporting in CTD format are a prerequisite for accepting your application for approval.<\/span><\/p><p><span style=\"color: #000000;\">With its GLP-accredited infrastructure, advanced analytical technologies and its professionals, Nano-Test fully meets the requirements of drug manufacturers for market approval tests. Collaborate with Nano-Test to speed up your application for admission and meet the requirements of the regulatory authorities.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Marktzulassungstests f\u00fcr Arzneimittel: Die qualitative Grundlage des Zulassungsverfahrens Die Entwicklung eines Arzneimittels umfasst jahrelange Forschungs- und Entwicklungsarbeiten sowie pr\u00e4klinische und klinische Studien. Doch selbst wenn all diese Arbeiten abgeschlossen sind, folgt noch die letzte und entscheidende Phase, bevor das Arzneimittel auf den Markt gebracht werden kann: der . In diesem Prozess m\u00fcssen die den Zulassungsbeh\u00f6rden \u2026 <a href=\"https:\/\/nano-test.de\/en\/2026\/10\/07\/tests-zur-markteinfuehrung-von-arzneimitteln\/\" class=\"more-link\" title=\"Continue reading &amp;lt;span class=\" screen-reader-text>Tests zur Markteinf\u00fchrung von Arzneimitteln\u201c&gt;Continue reading <span class=\"screen-reader-text\">Tests for the market launch of drugs<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":4553,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[],"class_list":["post-4552","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-blog"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Tests zur Markteinf\u00fchrung von Arzneimitteln | Nano-Test\u00ae<\/title>\n<meta name=\"description\" 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