ABSTRACT
Quality assurance (QA) is a total system approach to guarantee the safety and efficacy of finished products. It goes beyond simple inspection and testing. Quality control (QC) is usually considered as a subset of the total QA system. It is the most basic or minimum type of a quality program. A good QA program consists of a number of compliance programs that accomplish the quality objectives effectively. Key quality programs include, but are not be limited to, documentation systems, training, calibration, maintenance, audits, validation, change control systems, complaints, cleaning and sanitization, environmental monitoring, and stability programs. Some of the methods used for biotechnology-derived products that are the same as those used for traditional pharmaceutical products include product sterility, safety in experimental animals, and potency. The fundamental difference between the QC systems for biotechnology-derived products and other pharmaceutical products is in the methods that are used to determine the product’s characteristics: identity, purity, and impurity profile.
