QUALITY ASSURANCE

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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 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 assurance 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.      

Pharmaceutical quality assurance may be defined as the sum of all activities and responsibilities required to ensure that the medicine that reaches the patient is safe, effective, and acceptable to the patient. The purpose of QA in public pharmaceutical supply systems is to make certain that each medicine reaching a patient is safe, effective, and of standard quality. QA activities in a hospital or clinic should be comprehensive, spanning the entire supply process from medicine selection to patient use. QA covers all aspects that could have an impact on the quality of prescribed pharmaceutical products. This article focuses on some of the Pharmaceutical Quality Systems in relation to QA of manufactured medicines. QA covers all aspects that could have an impact on the quality of prescribed pharmaceutical products. The objectives of QA are:

  • to ensure that the prescribed medicine competently provides the desired effect to the person taking it;
  • to protect patients from accidentally being administered an incorrect or contaminated medication; and
  • to ensure medicines comply with the regulation.

FURTHER READING

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

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

Courvalin P, Leclercq R and Rice L.B (2010). Antibiogram. ESKA Publishing, ASM Press, Canada.

Denyer S.P., Hodges N.A and Gorman S.P (2004). Hugo & Russell’s Pharmaceutical Microbiology. 7th ed. Blackwell Publishing Company, USA. Pp.152-172.

Ejikeugwu Chika, Iroha Ifeanyichukwu, Adikwu Michael and Esimone Charles (2013). Susceptibility and Detection of Extended Spectrum β-Lactamase Enzymes from Otitis Media Pathogens. American Journal of Infectious Diseases. 9(1):24-29.

Finch R.G, Greenwood D, Norrby R and Whitley R (2002). Antibiotic and chemotherapy, 8th edition. Churchill Livingstone, London and Edinburg.

Russell A.D and Chopra I (1996). Understanding antibacterial action and resistance. 2nd edition. Ellis Horwood Publishers, New York, USA.

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