{"id":4636,"date":"2026-11-02T09:34:22","date_gmt":"2026-11-02T09:34:22","guid":{"rendered":"https:\/\/nano-test.de\/?p=4636"},"modified":"2026-11-02T09:34:22","modified_gmt":"2026-11-02T09:34:22","slug":"validierung-analytischer-verfahren-bei-arzneimitteln","status":"publish","type":"post","link":"https:\/\/nano-test.de\/en\/2026\/11\/02\/validierung-analytischer-verfahren-bei-arzneimitteln\/","title":{"rendered":"Validation of analytical methods for medicinal products"},"content":{"rendered":"<h1><span style=\"color: #000000;\">Validation of analytical methods for drugs: Guide to validation under ICH Q2(R2) and Q14<\/span><\/h1>\n<p><span style=\"color: #000000;\">Die Qualit\u00e4t, Sicherheit und Wirksamkeit eines pharmazeutischen Produkts h\u00e4ngen in hohem Ma\u00dfe von der Zuverl\u00e4ssigkeit der analytischen Methoden ab, mit denen es bewertet wird. Je genauer die Wirkstoffmenge, das Verunreinigungsprofil oder die Aufl\u00f6sungsgeschwindigkeit eines Arzneimittels gemessen werden, desto fundierter sind die Entscheidungen \u00fcber das Produkt. Aus diesem Grund <strong>ist die Validierung analytischer Methoden (Method Validation)<\/strong> der Grundpfeiler der pharmazeutischen Qualit\u00e4tskontrolle.<\/span><\/p>\n<p><span style=\"color: #000000;\">Im Rahmen der internationalen Harmonisierung legen die Leitlinien <strong>ICH Q2(R2)<\/strong> und die neu ver\u00f6ffentlichte <strong>ICH Q14<\/strong> fest, wie analytische Methoden validiert und entwickelt werden m\u00fcssen. In diesem Artikel werden wir die grundlegenden Parameter der analytischen Methodenvalidierung, die aktuellen Ans\u00e4tze der ICH-Leitlinien sowie die GLP-konformen Dienstleistungen von Nano-Test in diesem Bereich behandeln.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift --><\/span><\/p>\n<h2><span style=\"color: #000000;\">What is the validation of analytical methods and why is it required?<\/span><\/h2>\n<p><span style=\"color: #000000;\">The validation of analytical methods is the totality of the systematic work that is carried out to demonstrate the suitability of an analytical procedure for the specified purpose. A method is only considered \"valid\" when the validation has been completed and the performance parameters meet the acceptance criteria.<\/span><\/p>\n<p><span style=\"color: #000000;\">The need for validation arises in the following cases:<\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\"><strong>Entwicklung neuer Methoden:<\/strong> Wenn ein neues analytisches Verfahren zum ersten Mal angewendet wird,<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Methodentransfer:<\/strong> Bei der \u00dcbertragung einer Methode von einem Labor in ein anderes,<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Methoden\u00e4nderung:<\/strong> Wenn \u00c4nderungen an einer bestehenden Methode vorgenommen werden,<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Pharmakop\u00f6e-Konformit\u00e4t:<\/strong> F\u00fcr Methoden, die im Zulassungsantrag verwendet werden sollen,<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Routinem\u00e4\u00dfige Qualit\u00e4tskontrolle:<\/strong> Wenn eine kontinuierliche Verifizierung der Leistungsf\u00e4higkeit der Methode erforderlich ist.<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\">Results obtained with an unvalidated method are not accepted by the licensing authorities and can lead to the rejection of the application for admission.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift --><\/span><\/p>\n<h2><span style=\"color: #000000;\">Validation parameters within the framework of Ich Q2(R2)<\/span><\/h2>\n<p><span style=\"color: #000000;\">I Q2(R2) defines the basic parameters to be evaluated in the validation of analytical methods. Which parameters are required depends on the purpose of the method (identification, quantification, determination of impurities).<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H3-Unter&#252;berschrift --><\/span><\/p>\n<h3><span style=\"color: #000000;\">1. Accuracy<\/span><\/h3>\n<p><span style=\"color: #000000;\">Denotes the proximity of the measured value to the actual value. is usually evaluated using recovery studies (recovery) and should be in the range of 98-102%.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H3-Unter&#252;berschrift --><\/span><\/p>\n<h3><span style=\"color: #000000;\">2. Precision (Precision)<\/span><\/h3>\n<p><span style=\"color: #000000;\">It is evaluated on three levels: repeatability (repeatability), intermediate precision, and reproducibility (reproducibility). The RSD value (relative standard deviation) should usually be below 2%.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H3-Unter&#252;berschrift --><\/span><\/p>\n<h3><span style=\"color: #000000;\">3. Specificity (Specificity)<\/span><\/h3>\n<p><span style=\"color: #000000;\">The ability of the method to correctly measure the analytes despite the presence of impurities, matrix components and degradation products. It is evaluated on the basis of forced degradation experiments.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H3-Unter&#252;berschrift --><\/span><\/p>\n<h3><span style=\"color: #000000;\">4. Limit of detection (LOD) and limit of determination (LOQ)<\/span><\/h3>\n<p><span style=\"color: #000000;\">The LOD is the lowest concentration that can be detected with the method; The LOQ is the lowest concentration that can be reliably quantified. They are determined based on the signal-to-noise ratio (S\/N) or the standard deviation.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H3-Unter&#252;berschrift --><\/span><\/p>\n<h3><span style=\"color: #000000;\">5. Linearity (Linearity) and Measuring Range (Range)<\/span><\/h3>\n<p><span style=\"color: #000000;\">Specifies the concentration range in which the method reacts linearly. The correlation coefficient (R\u00b2) should generally be above 0.999.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H3-Unter&#252;berschrift --><\/span><\/p>\n<h3><span style=\"color: #000000;\">6. Robustness (robustness)<\/span><\/h3>\n<p><span style=\"color: #000000;\">Specifies the resistance of the method to small experimental fluctuations (pH, temperature, flow rate, column batch).<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- Tabellenanfang --><\/span><\/p>\n<h2><span style=\"color: #000000;\">Need for the validation parameters depending on the purpose of the method<\/span><\/h2>\n<p><span style=\"color: #000000;\">The following table summarizes which validation parameters within the framework of I Q2(R2) are required for which method of use of the method:<\/span><\/p>\n<table>\n<thead>\n<tr>\n<th><span style=\"color: #000000;\">Validation Parameters<\/span><\/th>\n<th><span style=\"color: #000000;\">Identification<\/span><\/th>\n<th><span style=\"color: #000000;\">Quantitative determination (assay)<\/span><\/th>\n<th><span style=\"color: #000000;\">Determination of impurities<\/span><\/th>\n<th><span style=\"color: #000000;\">Resolution speed<\/span><\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><span style=\"color: #000000;\"><strong>Accuracy<\/strong><\/span><\/td>\n<td><span style=\"color: #000000;\">\u2014<\/span><\/td>\n<td><span style=\"color: #000000;\">\u2713<\/span><\/td>\n<td><span style=\"color: #000000;\">\u2713<\/span><\/td>\n<td><span style=\"color: #000000;\">\u2713<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"color: #000000;\"><strong>Precision<\/strong><\/span><\/td>\n<td><span style=\"color: #000000;\">\u2014<\/span><\/td>\n<td><span style=\"color: #000000;\">\u2713<\/span><\/td>\n<td><span style=\"color: #000000;\">\u2713<\/span><\/td>\n<td><span style=\"color: #000000;\">\u2713<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"color: #000000;\"><strong>Specificity<\/strong><\/span><\/td>\n<td><span style=\"color: #000000;\">\u2713<\/span><\/td>\n<td><span style=\"color: #000000;\">\u2713<\/span><\/td>\n<td><span style=\"color: #000000;\">\u2713<\/span><\/td>\n<td><span style=\"color: #000000;\">\u2713<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"color: #000000;\"><strong>Lod \/ Loq<\/strong><\/span><\/td>\n<td><span style=\"color: #000000;\">\u2014<\/span><\/td>\n<td><span style=\"color: #000000;\">\u2014<\/span><\/td>\n<td><span style=\"color: #000000;\">\u2713<\/span><\/td>\n<td><span style=\"color: #000000;\">\u2014<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"color: #000000;\"><strong>Linearity<\/strong><\/span><\/td>\n<td><span style=\"color: #000000;\">\u2014<\/span><\/td>\n<td><span style=\"color: #000000;\">\u2713<\/span><\/td>\n<td><span style=\"color: #000000;\">\u2713<\/span><\/td>\n<td><span style=\"color: #000000;\">\u2713<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"color: #000000;\"><strong>Area<\/strong><\/span><\/td>\n<td><span style=\"color: #000000;\">\u2014<\/span><\/td>\n<td><span style=\"color: #000000;\">\u2713<\/span><\/td>\n<td><span style=\"color: #000000;\">\u2713<\/span><\/td>\n<td><span style=\"color: #000000;\">\u2713<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"color: #000000;\"><strong>Stability<\/strong><\/span><\/td>\n<td><span style=\"color: #000000;\">\u2014<\/span><\/td>\n<td><span style=\"color: #000000;\">\u2713<\/span><\/td>\n<td><span style=\"color: #000000;\">\u2713<\/span><\/td>\n<td><span style=\"color: #000000;\">\u2713<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span style=\"color: #000000;\"><!-- Ende der Tabelle --> <!-- H2-&#220;berschrift --><\/span><\/p>\n<h2><span style=\"color: #000000;\">Q14: \"Quality by Design\" (QBD) in the development of analytical methods<\/span><\/h2>\n<p><span style=\"color: #000000;\">I Q14, which came into force in 2023, introduced the \u201cQuality by Design (QBD)\u201d approach to the process of analytical method development. This guide provides new concepts that complement and reinforce the traditional validation approach:<\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\"><strong>Analytisches Zielprofil (ATP \u2013 Analytical Target Profile):<\/strong> Vorabdefinition der Leistungsanforderungen an die Methode.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Kritische Methodenparameter (CMP):<\/strong> Ermittlung der Faktoren, die die Methodenleistung beeinflussen.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Operativer Entwurfsbereich der Methode (MODR):<\/strong> Definition des Parameterbereichs, in dem die Methode zuverl\u00e4ssig funktioniert.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Risikobewertung:<\/strong> Systematische Bewertung des Einflusses der Methodenvariablen auf die Ergebnisse.<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\">I Q14 emphasizes that validation is not just a \"checklist\" but a process that requires a scientific understanding of the method. This approach ensures that the method is more robust in routine use and unexpected problems can be recognized in advance.<\/span><\/p>\n<div class=\"note\"><span style=\"color: #000000;\"><strong>Wichtig:<\/strong> ICH Q2(R2) und Q14 sind sich erg\u00e4nzende Leitlinien. Q2(R2) definiert, \u201ewas\u201c bei der Validierung zu tun ist, w\u00e4hrend Q14 festlegt, \u201ewie\u201c die Methode entwickelt und verstanden werden soll. Bei aktuellen Zulassungsantr\u00e4gen m\u00fcssen die Anforderungen beider Leitlinien gemeinsam bewertet werden.<\/span><\/div>\n<p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift: Nano-Test --><\/span><\/p>\n<h2><span style=\"color: #000000;\">GLP compliant services for validation of analytical methods with nano-test<\/span><\/h2>\n<p><span style=\"color: #000000;\">Die analytischen Methoden f\u00fcr Ihre pharmazeutischen Produkte bilden die Grundlage f\u00fcr Ihren Zulassungsantrag und Ihre routinem\u00e4\u00dfige Qualit\u00e4tskontrolle. <strong>Nano-Test<\/strong> ist mit seinen GLP-konformen Validierungsdienstleistungen im Rahmen von ICH Q2(R2) und Q14 ein zuverl\u00e4ssiger L\u00f6sungspartner f\u00fcr die pharmazeutische Industrie.<\/span><\/p>\n<div class=\"highlight\">\n<h3><span style=\"color: #000000;\">Nano-Test \u2013 Performance Description<\/span><\/h3>\n<p><span style=\"color: #000000;\">Nano-Test bietet f\u00fcr die Arzneimittelindustrie <strong>Dienstleistungen zur Validierung analytischer Methoden<\/strong> an. In unseren nach GLP und ISO\/IEC 17025 akkreditierten Laboren werden Arbeiten durchgef\u00fchrt, die vollst\u00e4ndig den ICH-Leitlinien Q2(R2) und Q14 entsprechen.<\/span><\/p>\n<p><span style=\"color: #000000;\">Our service portfolio:<\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\"><strong>Methodenentwicklung:<\/strong> ICH Q14-konforme, systematische Methodenentwicklung einschlie\u00dflich ATP- und MODR-Definitionen.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Validierungsstudien:<\/strong> Bewertung aller Parameter hinsichtlich Richtigkeit, Genauigkeit, Spezifit\u00e4t, LOD\/LOQ, Linearit\u00e4t, Messbereich und Robustheit.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Erzwungener Abbau (Forced Degradation):<\/strong> Untersuchungen unter S\u00e4ure-, Basen-, Oxidations-, Hitze- und Lichtstressbedingungen zur Bewertung der Spezifit\u00e4t.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Methodentransfer:<\/strong> Labor\u00fcbergreifender Methodentransfer und vergleichende Validierung.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Methodenverifizierung (Verification):<\/strong> Verifizierung von Pharmakop\u00f6e-Methoden vor dem routinem\u00e4\u00dfigen Einsatz.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Berichterstattung:<\/strong> Validierungsberichte im CTD-Format, mit Pr\u00fcfgenehmigung und f\u00fcr die Zulassungsbeh\u00f6rden akzeptabel.<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\">Our analyses use state-of-the-art devices such as HPLC-DAD, LC-MS\/MS, GC-MS\/MS and ICP-MS.<\/span><\/p>\n<\/div>\n<h3><span style=\"color: #000000;\">The advantages of nano-test in analytical validation:<\/span><\/h3>\n<ul>\n<li><span style=\"color: #000000;\"><strong>Beherrschung aktueller Leitlinien:<\/strong> Vollst\u00e4ndige Einhaltung der Anforderungen gem\u00e4\u00df ICH Q2(R2) und Q14.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>GLP-zertifizierte Infrastruktur:<\/strong> Alle Arbeiten werden gem\u00e4\u00df den GLP-Grunds\u00e4tzen und den ALCOA+-Anforderungen durchgef\u00fchrt.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Vielf\u00e4ltige technische Kompetenz:<\/strong> HPLC, GC, LC-MS\/MS, ICP-MS und spektroskopische Methoden unter einem Dach.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>CTD-konforme Berichterstattung:<\/strong> Vollst\u00e4ndige Validierungsdossiers gem\u00e4\u00df den Anforderungen von Modul 3.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Schnelle R\u00fcckmeldung:<\/strong> Berichterstattung innerhalb von 10\u201315 Werktagen bei Standard-Validierungsarbeiten.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Fachkundiges Team:<\/strong> Ein Team aus erfahrenen Chemikern in den Bereichen analytische Chemie und Validierung.<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift: Fazit --><\/span><\/p>\n<p><span style=\"color: #000000;\">The validation of analytical methods forms the basis for all data that prove the quality and safety of pharmaceutical products. Validation work carried out within the framework of ICH Q2(R2) scientifically proves the suitability of the method for its purpose, while the quality design approach introduced by I Q14 enables a deeper understanding of the method and its robustness in routine use.<\/span><\/p>\n<p><span style=\"color: #000000;\">With its infrastructure, advanced analytical technologies, and GLP-certified processes fully tailored to the current ICH guidelines, NANO-TEST fully meets the requirements of the pharmaceutical manufacturers for analytical validation. Collaborate with Nano-Test to speed up your application for admission and document the reliability of your analytical methods.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Validierung analytischer Methoden f\u00fcr Arzneimittel: Leitfaden zur Validierung im Rahmen von ICH Q2(R2) und Q14 Die Qualit\u00e4t, Sicherheit und Wirksamkeit eines pharmazeutischen Produkts h\u00e4ngen in hohem Ma\u00dfe von der Zuverl\u00e4ssigkeit der analytischen Methoden ab, mit denen es bewertet wird. Je genauer die Wirkstoffmenge, das Verunreinigungsprofil oder die Aufl\u00f6sungsgeschwindigkeit eines Arzneimittels gemessen werden, desto fundierter sind \u2026 <a href=\"https:\/\/nano-test.de\/en\/2026\/11\/02\/validierung-analytischer-verfahren-bei-arzneimitteln\/\" class=\"more-link\" title=\"Continue reading &amp;lt;span class=\" screen-reader-text>Validierung analytischer Verfahren bei Arzneimitteln\u201c&gt;Continue reading <span class=\"screen-reader-text\">Validation of analytical methods for medicinal products<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":4637,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[],"class_list":["post-4636","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 - 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