Good Manufacturing Practice (GMP)

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What is GMP?

GMP is centralize system for ascertain that the product are systematically manufactured and controlled as per the good quality standards. The main aim is to decrease the risk united in any pharmaceutical production which could not be eliminated through testing resultant product. There are seems main risks during the production of medicines like. Unexpected contamination in medicine products can be the cause to damage the health or even death.


Good manufacturing practice (GMP) is a system for ensuring that products are produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the resultant product. Main risks during manufacturing of medicines are: unexpected contamination in medicine products can be the cause to damage the health or even death. Incorrect labeling on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made. WHO has established detailed guidelines for good manufacturing practice. Many countries have formulated their own requirements for GMP based on WHO GMP. Others have harmonized their requirements, for example in the Association of South-East Asian Nations (ASEAN), in the European Union and through the Pharmaceutical Inspection Convention.

Why is GMP important?

Poor quality medicines are not only a health hazard, but a waste of money for both governments and individual consumers.

Poor quality medicines can damage health

A poor quality medicine may contain toxic substances that have been unintentionally added.
A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect.

GMP helps boost pharmaceutical export opportunities

Most countries will only accept import and sale of medicines that have been manufactured to internationally recognized GMP. Governments seeking to promote their countries' export of pharmaceuticals can do so by making GMP mandatory for all pharmaceutical production and by training their inspectors in GMP requirements.

WHO-GMP certification – a Misnomer!

The Good Manufacturing Practice (GMP) is a system (and part of quality assurance programme) to ensure that the pharmaceutical products are consistently produced and controlled according to quality standard. It is designed to minimize the risk involved in any pharmaceutical production that cannot be eliminated through testing the finished product. These risks are: unexpected cross contamination, causing damage to health or even death; wrong labels on containers causing confusion, even wrong medicines reaching patient; not enough or too much active ingredient, resulting in ineffective treatment or adverse effects.

Realizing the need of building the quality of the product during the entire process of manufacturing, the first GMP regulations were promulgated in 1963 in United States of America. They are revised in 1978 and have been updated regularly. The World Health Organization (WHO) too developed GMP as a part of its obligation “to develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products”. The first WHO GMP was developed during 1967-69 and revised it in 1975. They are subsequently revised periodically and many new additions are made in WHO expert committee on specifications for pharmaceutical preparations, fortieth report, 2006. In India, GMP, were given statutory status much later in 1988 and were incorporated as Schedule M under Drugs and Cosmetics rules 1945. This was later again revised in 2001 but implemented only in 2005 after stiff resistance from many small-scale manufacturers.

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