IMPORTANCE AND APPLICATION OF GOOD MANUFACTURING PRACTICE (GMP)

Good manufacturing practice (GMP) is simply defined as those general rules that govern the manufacture and/or production of a safe, efficacious and microbial-free pharmaceutical product. GMP are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, and quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidance that outlines the aspects of production and testing that can impact the quality of a product so that the finished product is deemed fit for consumption and free from microbial or chemical contamination. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation; and the main objectives of the GMP practices is to safeguard the health of the patient.

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GMP practices also ensure that good quality medicine or medical devices and active pharmaceutical products are always produced by these companies. Drugs and pharmaceuticals manufactured in conditions which violate the good manufacturing guidelines are said to be adulterated. Thus, compliance with the GMP is a mandatory aspect in all pharmaceutical manufacturing processes. GMP provides guidelines to the manufacturer (in a pharmaceutical manufacturing company for instance) on how efficient to control any form of contamination that may arise during the course of production. Several sources of contamination including contamination from raw materials and water are some critical areas where contamination during manufacturing of a pharmaceutical product can arise.

Apart from the contamination from raw materials and water, contamination during production can also arise from the air supply, packaging materials, and storage of the already finished goods/products. Contamination from personnel’s, manufacturing premises and the manufacturing equipment and/or instruments are other major sources of contamination that abound in a pharmaceutical manufacturing plant. And it is critical that the pharmaceutical microbiologists and/or the quality control/assurance personnel’s takes note of these important contamination sources so that sustainable measures could be established to contain their untoward effects on the production process or finished goods. Proper documentation and recordings of all the procedures or proceedings of the manufacturing company is another aspect of the good manufacturing practice that production companies must abide to. Such ledger or records must keep accurate and detailed information as to the quality and effectiveness of the manufactured products; and this must be done in details and in a well controlled manner for inspection by the GMP personnel’s.

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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