ABSTRACT
In France, lack of paediatric drugs leads pharmacies to produce many hospital preparations in order to meet prescribers'needs. To ensure the quality of these preparations, the pharmacy department of the Armand Trousseau Child Hospital set up a quality control system of its capsules. It integrates both European Pharmacopeia's requirements (Mass and Content uniformity test) and more strict internal quality specifications. They include exactitude of the average content compared to the awaited content, coefficient of variation of the contents and, "modified" content uniformity test. These criteria and the percentage of nonconformity are used as indicators to assure quality follow-up of the preparations. We reviewed quality control records for five hospital preparations produced over the last three years. We highlighted that lower dosage showed a higher percentage of nonconformity compared to higher dosage. Type of active ingredients was a key factors too (1,0% and 14.8% of non conform batches for ursodesoxycholic acid and for morphine hydrochloride respectively). Analysis showed that the essential character of content test because mass test is not predictive of the conformity of the batch. Content test was the main criterion to judge batches conformity. Thus, it will be generalized to all our preparations. These study results helped us to implement new procedures to assure an ongoing improvement of our practices of preparation.
