ABSTRACT
The pharmaceutical industry is responsible for making quality medicines, diagnostic agents and medical devices available to patients worldwide. Regulatory authorities all over the world have stringent rules and procedures for the review and approval of pharmaceutical products before granting permission for their marketing. The purpose of this stringent control on marketing approval for pharmaceutical products is to ensure their safety, efficacy and quality. During product development, correlation of the critical quality attributes to the safety, efficacy and quality of the product is well established (see Chapters 4, 7 and 9), and control measures during commercial manufacturing assure that the same consistent quality drug product is made available to patients. This is where the role of maintaining a state of control in the manufacture and supply chain of pharmaceutical products by applying pharmaceutical quality system (PQS), risk management, good manufacturing practices (GMP) and process validations is of utmost importance and the chapter will focus on the scope and implementation of PQS.
