Quality concept of parenterals in Europe

Different types of dosage forms are available for parenteral use. They include solutions and suspensions for injection and infusion, sterile powders and lyophilisates which are administered after reconstitution with water for injection or other solutions and finally, controlled-release products (e.g., microparticles or implants). For the quality characterization of the drug products the quality concept of the drug substance has to be considered in addition to the finished product. Several Guidelines on the European basis and others are available, but the harmonisation of the quality concept on an international basis is highly appreciated by pharmaceutical industries. The ICH process is an extremely positive development aiming for a unique chemical and pharmaceutical documentation which can be submitted to all authorities worldwide. Beside the existing standards already internationally harmonised additional aspects will be discussed which include for the quality concept of the drug substance the manufacture and quality control during manufacture and specification of impurities and for the drug products particulate matter tests, specification of content, uniformity of mass and content and the biopharmaceutical characterization.