Produktionsparameter fÃ¼r die GleichfÃ¶rmigkeit des Gehaltes einzeldosierter Arzneimittel
Werner Altenschmidt a1) und Heribert HÃ¤usler b
Biberach/RiÃ 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 âUniformity of content of single dose preparationsâ or âContent Uniformityâ 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 Â· GleichfÃ¶rmigkeit des Gehaltes, Produktionsparameter Â· ProzeÃsteuerung Â· QualitÃ¤tssicherung
pharmind 2000, Nr. 2, Seite 144