Fortlaufende Stabilitätsprüfungen von pflanzlichen Arzneimitteln
Bewertung von Abweichungen und Trends
GMP / GLP / GCP
Abstract
Ongoing stability testing of herbal medicinal products: evaluation of deviations and trends
In ongoing stability tests required by the EU GMP Guidelines, which must also be carried out for herbal medicinal products, the focus of the supervisory authorities lies increasingly on the evaluation of deviations in the results, e.g., of Out of Specification (OOS) results. It is the responsibility of the pharmaceutical company to decide within the framework of established standard operating procedures whether or not the deviation is a confirmed OOS result. According to Chapter 6.35 of the EU GMP Guideline, a confirmed OOS result or a significant negative trend must be reported to the competent authorities. However, an impact on batches on the market is not appropriate in many cases, since herbal preparations are mixtures of natural constituents with a complex range of ingredients, and positive or negative variation of individual constituents has no effect on the safety and efficacy of the medicinal product. Therefore, this contribution particularly presents practical experiences in the evaluation of deviations and trends with higher and lower contents using various examples. Since natural fluctuations are to be expected for herbal medicinal products, measures are only considered necessary in the sense of a differentiated consideration of the trend concept if trends deviate from the empirical results of many batches.
Zusammenfassung
Bei den nach dem EU-GMP-Leitfaden vorgeschriebenen fortlaufenden Stabilitätsprüfungen, die auch für pflanzliche Arzneimittel durchgeführt werden müssen, liegt der Fokus der Überwachungsbehörden zunehmend auf der Bewertung von Abweichungen der Ergebnisse, z. B. von Out-of-Specification(OOS)-Ergebnissen Die Entscheidung, ob es sich um ein
