ABSTRACT
I. INTRODUCTION Total quality control is a concept that strives to produce a perfect product by a series of measures requiring organized effort by an entire company to prevent or eliminate errors at every stage in production. Though the responsibility for assuring product quality belongs principally to quality assurance, many other departments and disciplines within a company must also be involved. A team effort is required for an effective quality assurance program. The quality of a drug product must be built in during product and process design, as well as during the production and packaging of the product. The physical plant design, space, ventilation, cleanliness, sanitation, etc., during routine production of a product all play an integral role in the assurance of producing a quality product. The product and process design begins with, and includes, research and development, preformulation, and physical, chemical, therapeutic, and toxicologic considerations. Product quality, then, considers materials, in-process and product control (including specifications and tests for the actives and excipient of the product), specific inspection procedures for the product, containers, packaging, and labeling to ensure that the container closure system provides functional protection of the product against such factors as moisture, oxygen, light, volatility, and drug/package interaction. Provision is required for a cross-referencing system to allow for any batch of a product to be traced from its raw materials to its final destination in the event of the need to investigate unexpected difficulties.
