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Produktionsparameter für die Gleichförmigkeit des Gehaltes einzeldosierter Arzneimittel

Werner Altenschmidt a1) und Heribert Häusler b

Biberach/Riß a1) und Boehringer Ingelheim Pharma KG, A Pharma Herstellung Nicht-Feste Formen, Ingelheim/Rhein b

Production Parameters for Content Uniformity of Single-Dose Drug Preparations

In a previous publication a description of production parameters for the uniformity of mass according DAB (German pharmacopoeia) 1997 / Ph. Eur. 1997 was given. The present paper is a continuation and shows which limits the parameters of a production for the content uniformity must be kept to get samples with a high degree of acceptance. -The “Uniformity of content of single dose preparations” or “Content Uniformity” are quality standards for which the pharmacopeias give exact details with regard to sample size and the acceptance criteria for the results obtained with theses samples. The following article deals with the consequences for drug manufacture arising from these quality specifiations in the pharmacopeias. It appears that provided in-process variations remain below a certain limit, a high probability of acceptance is to be expected, regardless of the specifications in the relevant pharmacopeias. The production department must comply with this limit and it should also be taken into account during the development stage of the product.

Key words Einzeldosierte Arzneimittel · Gleichförmigkeit des Gehaltes, Produktionsparameter · Prozeßsteuerung · Qualitätssicherung