Quality Assurance In Pharmaceutical Industry

1194 Words5 Pages
The pharmaceutical industry is rapidly changing due to globalization, increased competition, cost constraints, demands for efficacy, and stringent international regulation requirements. The quality, safety and efficacy attributes of products must be validated so that the consumer health and wellbeing is not compromised. Quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. The quality in the pharmaceutical industry has become a very important topic. There has been a growing awareness for the significance of the…show more content…
It is a regulatory requirement that the manufacture must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended purpose, comply with the requirements of their marketing authorization and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality is the responsibility of senior management and requires the participation and commitment of staff in many different departments and at all levels within the organization, the organization’s suppliers and the distributors. To achieve the quality objective reliably there must be a comprehensively designed and correctly implemented system of quality assurance incorporating GMP and quality control. The quality system should be fully documented and its effectiveness monitored. All parts of the quality assurance system should be adequately staffed with competent personnel, and should have suitable sufficient premises, equipment and facilities. There are several focus areas in quality assurance in the pharmaceutical industry. I have selected a few and decided to write my paper on developments discussed below namely, Validation, Quality Risk Management, Audits and Inspections, Quality Management System and Quality by…show more content…
Process validation incorporates a lifecycle approach linking product and process development, validation of commercial manufacturing process and maintenance of the process in a state of control during routine commercial production. Process validation should confirm that the control strategy is adequate to the process design and the quality of the product. The validation should cover all manufactured strengths and all manufacturing sites used for production of the marketed product. Process validation involves a series of activities taking place over the lifecycle of the product and process. The FDA cGMP guidance describes process validation activities in three

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