Quality Assurance is a concept of vouching that the pharmaceutical products are up to the quality level required for their intended use accounting to Good Manufacturing Practices. It is a company based concept and an international standard like ISO 9000 is considered as a guideline to vouch that a company’s QA system is effective and ready to be implemented. It is a planned and systematic activity that carries pereriodic conformance audits of the operations of the systems. Along with the Pharmaceutical Industry, food and biotech industries also need quality assurance products and FDA regulations to avoid the risk of the consumer’s health. Quality Assurance is a managerial tool that objectifies Product and Safety liability in Pharmaceutical Industry.
Quality Control is a part of GMP that refers to sampling, specification and testing organization’s documentations that does not release any pharmaceutical product without their quality test. It is a lab based detailed system with effective techniques of inspection and control covering the production, evaluation and distribution of every pharmaceutical product. Quality Control is a corrective tool that identifies the defects after the products are developed and before they are released. All the methods used by Quality Control are first sampled and then validated by having traceable records of all the pharmaceutical activities. This carries out either qualitative or quantitative analysis to determine the quality of the product.
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