QUALITY ASSURANCE

by DrChika

Quality assurance (QA) is a planned and systematic process used for evaluating and monitoring the quality and appropriateness or suitability of a product or given service. QA is related but different from quality control (QC). It is mainly geared towards finding a problem that is associated with a given product and managing it so that the product can be certified safe for consumption.

According to the World Health Organization (WHO), QA is defined as the total process whereby the quality of laboratory reports can be guaranteed. Thus, QA is summarily the right result, at the right time, on the right clinical/environmental specimen, from the right patient, with the result interpretation based on the correct reference data, and at the right place.

QA encompasses all the processes used to evaluate and monitor the quality of services rendered in a healthcare facility, hospital laboratory, pharmaceutical companies and other allied industries. QA is the summation of all the processes ensured during the production of a product in order to ensure that the final product is of the desired quality. It ensures that the finished product meets the intended use for which it was produced.

Pharmaceutical products including but not limited to drugs, vaccines and injections are sterile products that enter the body, and they must be certified safe and fit for human consumption. It is the task of quality assurance personnel’s in such a company to ensure that these products meet their specifications and that they are safe for consumption.

QA also encompass the good manufacturing practices (GMPs) carried out in pharmaceutical companies and other allied companies to ensure the production of quality products. QA protocols employed in pharmaceutical companies as well as in the microbiology laboratory in hospitals and educational institutions – are mainly applied to test the final product or results of a particular process in order to recognize potential problems associated with them.

It is different from in-process controls – which generally test the equipment and other processes of a manufacturing method in order to ensure that they are fit, safe and reliable to carry out the actual manufacturing. In in-process control, tests are carried out during the actual manufacturing process as against QA – which includes all necessary arrangement carried out to ensure that the final product is of the intended use after production.

Both quality control and in-process control are components of the good manufacturing practice (GMP) carried out in production companies especially pharmaceutical companies to ensure that only sterile product are produced and released into the market for human or animal consumption.          

References

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Ashutosh Kar (2008). Pharmaceutical Microbiology, 1st edition. New Age International Publishers: New Delhi, India. 

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Block S.S (2001). Disinfection, sterilization and preservation. 5th edition. Lippincott Williams & Wilkins, Philadelphia and London.

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Joslyn, L. J. (2000). Sterilization by Heat. In S. S. Block (Ed.), Disinfection, Sterilization, and Preservation (5th ed., pp. 695-728). Philadelphia, USA: Lippincott Williams and Wilkins.

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