QUALITY SYSTEMS AND STANDARD OPERATING PROCEDURES – A REVIEW

It is mandatory for sponsors of clinical trials and contract research organizations alike to establish, manage and monitor their quality control and quality assurance systems and their integral standard operating procedures and other quality documents to provide high-quality products and services to fully satisfy customer needs and expectations. Quality control and quality assurance systems together constitute the key quality systems and parts of quality management. Quality control is focused on fulfilling quality requirements, whereas quality assurance is focused on providing confidence that quality requirements are fulfilled. The quality systems must be commensurate with the company business objectives and business model. Top management commitment and its active involvement are critical in order to ensure at all times the adequacy, suitability, effectiveness and efficiency of the quality systems. Effective and efficient quality systems can promote timely registration of drugs by eliminating waste and the need for rework with overall financial and social benefits to the Company. The mission of a quality assurance department is to provide an effective and efficient quality assurance system and counsel for the operational units. The development and use of SOPs are an integral part of a successful quality system as it provides individuals with the information to perform a job properly, and facilities consistency in the quality and integrity of a product or end result.

Keywords: Quality systems, Quality assurance, Quality control, Quality management, Standard Operating Procedure