ABSTRACT
The motivation for the use of a contract manufacturing organizations was to avoid the added expense of separate or additional facilities for these formulations and presentations. These were the predominant use of contract manufacturing services until the advent of the biotechnology industry. The Pharmaceutical Inspection Convention/Scheme has expanded its membership to include all of the major pharmaceutical regulatory bodies and is increasingly important in development of regulatory consensus. Pharmacopeia have been established in many countries, regions, and internationally in an effort to standardize the testing of active pharmaceutical ingredients, excipients, containers and closures, and pharmaceutical products and to ensure the efficacy of the medicines delivered to the consumer. The production of parenteral formulations has typically involved the preparation of solutions and suspensions using vessels equipped with a means for agitation and a method for heating/cooling the contents. Isolation technology has become the dominant environmental control system for the filling of aseptically filled products.
