QUALITY CONTROL AND QUALITY ASSURANCE

Quality control (QC) is defined as a monitoring system that is used for detecting and correcting analytical errors by establishing performance limits. QC is a procedure or set of procedures intended to ensure that a manufactured product including pharmaceutical and medical products or performed services adheres to a defined set of quality criteria or meets the laid down requirements of the products. QC is similar to, but not identical with, quality assurance (QA). It is a major good manufacturing practice (GMP) carried out in production companies to avoid microbial contamination of finished products. Quality control covers all the aspects of quality assurance (QA) which concerns itself with the control of errors in the performance of tests and verification of test results. A good and sustainable QC practice must be practical, achievable and affordable. In quality control processes, every available and necessary test including microbial tests to be carried out are conducted at each stage of the manufacturing process.

And QC ensures that finished products are not released into the market for consumption until such products have satisfactorily passed the stipulated QC test that pertains to that particular manufacturing process or plant and product. Several pharmaceutical products including drugs, vaccines and injection water are easily contaminated with pyrogens (fever-inducing agents produced by microbes) during the manufacturing process. Thus, the test for the presence of pyrogens in finished pharmaceutical products is one of the typical QC tests conducted to ensure the safety of the product produced. All culture media, reagents, equipments and other instruments for microbiological analysis must be adequately controlled for optimum performance in order to minimize possible errors due to their usage.

QUALITY ASSURANCE

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. 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 interpretationbased 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 equipments 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.    

Further reading

Bushell M.E (1998). Application   of   the   principles   of   industrial   microbiology   to   biotechnology (ed. Wiseman, A.) Chapman and Hall, New York.

Byong H. Lee (2015). Fundamentals of Food Biotechnology. Second edition. Wiley-Blackwell, New Jersey, United States.

Frazier W.C, Westhoff D.C and Vanitha N.M (2014). Food Microbiology. Fifth edition. McGraw-Hill Education (India) Private Limited, New Delhi, India.

Jay J.M (2005). Modern Food Microbiology. Fourth edition. Chapman and Hall Inc, New York, USA.

Bushell M.E (1998). Application   of   the   principles   of   industrial   microbiology   to   biotechnology (ed. Wiseman, A.) Chapman and Hall, New York.

Farida A.A (2012). Dairy Microbiology. First edition. Random Publications. New Delhi, India.

Nduka Okafor (2007). Modern industrial microbiology and biotechnology. First edition. Science Publishers, New Hampshire, USA.

Roberts D and Greenwood M (2003). Practical Food Microbiology. Third edition. Blackwell publishing Inc, USA.

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