ROLES OF REGULATING AGENCIES FOR FOODS, PHARMACEUTICALS AND OTHER CONSUMABLE PRODUCTS

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There are several bodies or organizations that oversee and ensure that food producing companies, pharmaceutical company and other companies involved in the business of producing food/medicines meant for human consumption comply strictly with regulations, laws or guidelines that allow them to perform their job at the minimal risk there is. The Food and Drug Administration (FDA) of the United States of America is one of such organization saddled with the responsibility of ensuring that pharmaceutical industries and/or food industries comply with the principles of GMP in the U.S. Other countries also have their own regulatory agents that ensure the safety and efficaciousness of medicines or foods produced locally; and these organizations ensure that these manufactured products are safe for human consumption and free form all sore of contamination that may cause infection or death of the users.

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The National Agency for Food and Drug Administration and Control (NAFDAC) is Nigeria’s own agency that regulates the activities of companies involved in the production of food, drugsand other products consumed by the Nigerian populace. Other regulatory agencies in other countries are Medicines and Healthcare products Regulatory Agency (MHRA) in UK; Korea Food and Drug Administration (KFDA) in Republic of Korea (South Korea); Therapeutical Goods Administration (TGA) in Australia; Medicines Control Council (MCC) in South Africa; and Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency Brazil) (ANVISA) in Brazil. Those empowered by the law pay regular or time-bound visits to these food and drug manufacturing companies to ascertain their level of compliance to the GMP regulations. Regulatory agencies (including the FDA in the U.S. and regulatory agencies in other nations) are authorized by law to conduct unannounced or scheduled inspections to manufacturing industries in order to ensure their compliance to GMP practices.

Pharmaceutical/food manufacturing companies that fail to meet the expectations of the GMP regulations (as it is unique to each country or region) risk the possibility of having their company shutdown, sealed or bound from any further production. Thus it is critical that manufacturing companies update themselves with the changing guidelines of the GMP of their country to ensure compliance to these regulations in other to stay in business. It is noteworthy to mention that when the principles of GMP are not strictly adhered to by manufacturers of food or drugs, everyone including the consumers and the producers becomes affected in one way or the other. The manufacturer experiences great economic loss due to low patronage of their product by consumers; and this is usually attributable to several issues especially to the low effectiveness of the product or the microbial or non-microbial contamination of the product.

In other cases, the GMP regulators or the government agency saddled with the responsibility of ensuring quality of manufactured goods may clampdown on such companies and have their plants partially or permanently sealed. Once production ceases, employee’s losses their jobs, profits drops and the company may go bankrupt. The consumer may on the other hand become sick simply by using a contaminated pharmaceutical product or food product. Serious health challenges usually ensue when the consumed product is contaminated with infectious agents such as Salmonella species, Pseudomonas species, Escherichia coli and Klebsiella species.

This causes morbidity and mortality in human population coupled to the economic loss involved in the treatment of the affected individuals. A disease outbreak may occur when such contaminated product is consumed or used by a sizeable number of the population. Pharmaceutical products or preparations are easily contaminated before and after manufacturing if good manufacturing practices are not imbibed during production. Since there are several sources of contamination of pharmaceutical preparations, it is therefore vital that every manufacturing process in a pharmaceutical company are carried out in manners that will help to keep microorganisms at bay – even though it is almost impossible to rule out contaminating microbes from the production process.        

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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