ABSTRACT

Quality assurance plays a central role in determining the safety and efficacy of medicines. Highly specific and sensitive analytical techniques hold the key to the design, development, standardization and quality control of medicinal products. They are equally important in pharmacokinetics and in drug metabolism studies, both of which are fundamental to the assessment of bioavailability and the duration of clinical response. Quality Assurance persons involves in various aspects. Quality is the primordial intention to any industry and its products manufactured. Multiple views on obtaining such quality are the current interest in the pharmaceutical industry. Acquainted with a practice that puts us in common and routine convention ensured to deliver a quality that sounds globally in terms of a spoken quality is on the dais of pharmaceutical arena. Validation is the mean of catering enormous benefits to even more than the acceptable quality level which in the global standard scale. Quality Assurance mainly Categorized into Validation Quality Assurance, Documentation Quality Assurance, Analytical Quality Assurance, In process Quality Assurance, Audit/Compliance Quality Assurance, Quality Management System Quality Assurance.

Key words: Pharmacokinetics, Metabolism, Bioavailability, Primordial intention, Validation Quality Assurance, Documentation Quality Assurance and Analytical Quality Assurance.