Cleaning Validation in the Production of Active Ingredients and Medicinal Products from Herbal Origin

Rubrik: GMP / GLP / GCP

(Treffer aus pharmind, Nr. 01, Seite 44 (2023))

Herkenrath J | Robach K | Römann P | Poetsch F | Steinhoff B

Cleaning Validation in the Production of Active Ingredients and Medicinal Products from Herbal Origin / A Risk-based Approach · Herkenrath J¹, Robach K², Römann P³, Poetsch F⁴, Steinhoff B⁵ · ¹Viatris Healthcare GmbH, Troisdorf und Deutsche Homöopathie-Union DHU-Arzneimittel GmbH & Co. KG, Karlsruhe und Salus Haus Dr. med. Otto Greither Nachf. GmbH & Co. KG, Bruckmühl und Bad Heilbrunner Naturheilmittel GmbH & Co. KG, Bad Heilbrunn und Bundesverband der Arzneimittel-Hersteller e. V., Bonn
In accordance with Chapters 3 and 5 of the EU GMP Guideline [ 1 , 2 ] the use of clean equipment and the prevention of cross-contamination are basic principles of GMP. Besides the attention to the design of the premises and equipment, such preventive measures should be supported by attention to process design and implementation of any relevant technical or organisational measures. This includes effective and reproducible cleaning processes to control the risk of cross-contamination. In accordance with Annex 15 to the EU GMP Guideline [ 3 ], cleaning validation should be performed to confirm the effectiveness of any cleaning procedure for all product ...