Qualification of Suppliers of Cultivated and Wild Collected Medicinal Plants

Rubrik: GMP / GLP / GCP

(Treffer aus pharmind, Nr. 01, Seite 66 (2017))

Raiser M | Hofmann W | Stekly G | Tegtmeier M | Torres Londoño P | Steinhoff B

Qualification of Suppliers of Cultivated and Wild Collected Medicinal Plants / Raiser et al. • Qualification of Suppliers · Raiser M, Hofmann W, Stekly G, Tegtmeier M, Torres Londoño P, Steinhoff B · ¹Dr. Willmar Schwabe Business Services GmbH & Co. KG, Karlsruhe und ²Biologische Heilmittel Heel GmbH, Baden-Baden und ³SALUS Haus GmbH & Co. KG, Bruckmühl und ⁴Schaper & Brümmer GmbH & Co. KG, Salzgitter und ⁵Kräuter Mix GmbH, Abtswind und ⁶Forschungsvereinigung der Arzneimittel-Hersteller e. V. (FAH), Bonn und ⁷im Namen der Arbeitsgruppe „Lieferantenqualifizierung“ der Forschungsvereinigung der Arzneimittel-Hersteller e. V. (FAH)
Each manufacturer of medicinal products has to establish a Quality Assurance (QA) system in order to guarantee a high and consistent quality of its products. This also applies to the manufacture of medicinal products of herbal origin (herbal products and homeopathic medicinal products). According to Chapter  5 of the EU Good Manufacturing Practices (GMP) Guideline [ 1 , 2 ], qualification of suppliers is part of the QA system. Suppliers 1) of cultivated and wild collected raw materials of natural origin have to be qualified as well. However, due to the natural origin and the particularities of the production of ...