Verification of chromatographic pharmacopoeial procedures for herbal drugs and herbal drug preparations

Rubrik: Arzneimittelwesen

(Treffer aus pharmind, Nr. 09, Seite 1159 (2021))

Preisitsch M | Giera D | Flamm D | Franz-Oberdorf K | Gerke H | Steinhoff B

Verification of chromatographic pharmacopoeial procedures for herbal drugs and herbal drug preparations / Recommendations from industry · Preisitsch M¹, Giera D², Flamm D³, Franz-Oberdorf K⁴, Gerke H⁵, Steinhoff B⁶ · ¹ PhytoLab GmbH & Co. KG, Vestenbergsgreuth und G. Pohl-Boskamp GmbH & Co. KG, Hohenlockstedt und Systema Natura GmbH, Flintbek und Finzelberg GmbH & Co. KG, Andernach und Schaper & Brümmer GmbH & Co. KG, Salzgitter und Bundesverband der Arzneimittel-Hersteller e. V., Bonn
The correctness of analytical results is an essential requirement for ensuring the quality, safety and efficacy of medicinal products. Analytical procedures described in the European Pharmacopoeia (Ph. Eur.) are regarded as validated, as validation is considered to be performed in the course of the development of the respective monograph . Basis for this validation is the Technical Guide for the Elaboration of Monographs [ 1 ] which comprises in its chapter 3 “Analytical Validation” the requirements of Guideline ICH Q2(R1) [ 2 ] and further guidance on specific application to methods used in the Ph. Eur. As indicated in General Notices of the Ph. Eur. [ 3 ] ...