Quality Assurance

Abstract

The past twenty years has seen a marked increase in the number and complexity of pharmaceutical, biological, and medical device regulations passed into law. So numerous and demanding have been these regulations that they have necessitated the development of a new branch of the quality maintenance system, commonly termed quality assurance. The establishment of quality assurance procedures and documenta tion by biotechnology and other healthcare companies is provided for in the cGMP regulations of the FDA. Quality assurance is basically a continual, proactive process for the establishment, monitoring, and sup porting of those systems and programs that assure that products and processes meet their predetermined specifications and quality characteristics. In essence, quality assurance policies and procedures not only meet governmental regulatory require ments, but also promote efficient and cost effective development and manufacturing of products, which are extremely important to the bottom line of for profit businesses. Those quality assurance systems that increase efficiency and employee productivity in the manufacture of biotechnology and biomedi cally related products and devices include, but are not limited to, preproduction quality assurance, documentation and labeling controls, establishment of a product quality control system, equipment calibration and certification, quality related employee training, internal audits and external ven dor audits, and customer complaint reso lution systems. The realization of “total quality control systems,” which infuses quality maintenance as a priority goal in all phases of product research, development, manufacturing, sales, and customer service, has also been placed under the control of quality assurance managers as a means of guaranteeing that biotechnology companies produce the highest quality products at the lowest possible cost.