ABSTRACT

Quality assurance has as its objective the measurement of product attributes to ensure that the product being manufactured conforms to its specifications. To assure production of the product with desired attributes requires testing during manufacture. The ultimate responsibility for the quality of a product rests with manufacturing personnel. However, the total control of quality requires an organized effort of the entire company to assure that every component and every step of the parenteral manufacturing process be regarded as critical and be performed according to the specified requirements that assure that the required quality is in the finished product.