Abstract

PHARMACEUTICAL QUALITY ASSURANCE FRAMEWORK FOR PHARMACEUTICAL PRODUCT

Megha S. Jadhav, Dr. Prashant S. Malpure*, Sonali Nadekar and Ganesh Murkute

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Abstract

Quality Assurance in pharmaceutical supply system is to help ensure that which medicine reaching a patient save, effective and acceptable quality.[2] It is a wide concept and covers all aspects that could have an impact on the quality of prescribed pharmaceutical products.[8] Pharmaceutical industry is a very vital segment of our health care system, which deals with manufacturing and marketing of pharmaceuticals and biological and treatment of illnesses in addition to carrying out research to create new goods for the welfare of people So maintenance of quality is very necessary to prevent health hazard as many pharmaceutical products are life saving products, Regulatory agencies of various countries noted that there are deficiencies in conventional quality management systems, so they start ad Therefore, low-quality products run the risk of having serious negative effects on patients or consumers, including death. opting this approach called Total Quality Management (TQM). It is a method of Quality Assurance (QA).[3]

Keywords: Quality Assurance, Pharmaceutical Quality Assurance, Framework, Quality Assurance methods.