What is GMP? History of GMP

1.      GMP is a legal requirement

Drugs that act strongly upon the body are one but removed from poison. While Drugs can save lives, if the use method gets wrong, it may become lethal poison. Therefore, in the manufacture of pharmaceutical products, quality control thorough for safety and efficacy is required so that the intended drug effect can be exactly achieved and safely used. Hence, GMP (Good Manufacturing Practice) is enacted as a legal requirement to be complied by pharmaceutical manufacturers to ensure that the products are continuously produced with the same high quality. So, GMP is a matter of law. Among the laws related to pharmaceutical affairs in Japan, the “Regulations for Buildings and Facilities for Pharmacies etc.” and “Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs” (refers to as “GMP Ministerial Ordinance”) issued by Ministry of Health, Labour and Welfare are the GMP for the pharmaceutical manufacture.

In addition, there are notifications and administrative notices published to specify the points to be well understood and attentions to be paid for the smooth enforcement and operation of the laws. Commonly, So-called a law with legally binding force means a code, or a cabinet order, a ministerial ordinance, etc. Though a notification may be conceived as an administrative document, it should be regarded as a legally binding force in fact, since the authority’s viewpoints are indicated on it.

2.      History of GMP

Pharmaceutical GMP was first introduced after some incidents caused by potential risks hidden in pharmaceutical products. In the United States, incidents of poisoning by unclean slaughter-house and harmful medicines of painkiller became a big problem, later the Federal Food and Drugs Act was enacted in 1906. It was an epoch-making law to regulate inferior drugs and foods, but it was mainly the regulations on indication with regard to pharmaceuticals. There were various drug-induced suffering incidents happened, thereafter it had never been the calling bigger issue than the need to protect consumers. It was 1937 when Elixir Sulfanilamide incident occurred and over 100 people, most were young children died. After the incident, the Federal Food, Drug, and Cosmetic Act was approved by Congress in 1938, all the manufacturers had to implement pre-marketing safety test. Furthermore, based on this law, cosmetic products and medical devices also needed to be under the control of FDA (Food and Drug Administration), and the distinctive authority of facility inspections and the basic standards on food were first specified.

Since several major drug-induced suffering incidents also happened in 1940s and 1950s, and FDA had revised significantly the concepts concerning with production and quality control, which led to the establishment of GMP. In 1960, in the wake of thalidomide incident, public opinion on strengthening the pharmaceutical regulatory increased, as a result, FDA revised the law in 1963, adding obligations as to prove the efficacy, to get the informed consent for clinical trials and report to FDA, to report adverse effect and so on. This is substantially the world’s first GMP. Then, WHO established the GMP in 1969 and recommended all the member nations to adopt and implement a certification system based on GMP in pharmaceutical trade. Later on, in 1978, the GMP for pharmaceuticals and medical devices, almost the same as the current one, was adopted by FDA, this has become a standard of GMP for all other countries.

On the other hand, in Japan, along with the revision of the Pharmaceutical Affairs Act in 1980, the “Regulations on Quality Control and Manufacturing Control of Pharmaceuticals” (the Ministerial Ordinance on GMP) was established specifying the requirements pertaining to management of pharmaceutical manufacture, and the “Regulations on Buildings and Facilities for Pharmacy, etc.”, that specified the requirements pertaining to the manufacturing facilities, was revised. After that, the Pharmaceutical Affairs Act was revised in 1994, which defined the GMP requirements to be complied by pharmaceutical manufacturers. In addition, it became a requirement for manufacture and market permission in line with the revision of the Pharmaceutical Affairs Act made again in 2005. Whether a pharmaceutical manufacture complies with GMP or not? That will be determined by the authority through the regulatory investigation (inspection) into the manufacturing facility. This kind of GMP compliance inspection must be received every 5 years in Japan.