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quality assurance and quality control in indian pharmaceutical industry

The Pharmaceutical Industry holds a very important role in production, development and marketing of medications with a sheer responsibility of Human healthcare. It is also seen evaluating day by day due to globalization, increased competition, cost constraints, demands for efficacy, international regulation, supply chain competition and product as well as process complexity. With this comes along quality concerns of the pharmaceutical equipment and products that have direct contact with the humans. Thus, Quality assurance and Quality Control is important in Pharmaceutical Industry to manufacture and deliver complete zero-defect products with the excellent quality, efficacy and safety for the consumers. Ignoring quality in pharmaceutical production is equal to risking human’s life and losing your credibility.
To never fall a prey to such loss, let’s understand the terminology of Quality Assurance and Quality Control with their importance in Pharmaceutical Industry: –

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.

Any Pharmaceutical manufacturer holds the responsibility to control the sources of product quality variation and assure that the testing results are in compliance with the standards and specifications with the product stability. If you are a Pharmaceutical Company and you have been looking out for Quality assurance and Quality Control products, then we got your back.

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