Drug Information Q&A Q38. How is the quality of drugs ensured?
Answer
Since drugs are taken into our bodies, it is important that they are not only "effective" but also "safe to use. For this reason, drugs are subjected to a high level of strict quality control in various processes from manufacturing to distribution and use.
Explanation
The Pharmaceutical Affairs Law mandates strict management of drugs to ensure their efficacy and safety. In addition to the legal requirements, the pharmaceutical industry has established self-imposed regulations to further improve and maintain the quality of drugs.
At the stage of manufacturing drugs, there are standards not only for the overall manufacturing process from the receipt of raw materials to the shipment of finished products (drugs), but also for the layout of factory buildings, machinery, and equipment to eliminate human error.
For example, in the manufacture of pharmaceutical products, a quality standard is prepared for each drug item. Quality standards are used to assure the quality of the pharmaceuticals manufactured and sold, and include items approved for manufacturing and marketing and other necessary quality-related matters.
By practicing these controls, we are working to produce approved drugs with high quality and stability. This standard is called GMP (Good Manufacturing Practice).
GQP (Good Quality Practice), GVP (Good Vigilance Practice), and GPSP (Good Good Practice in Post-Marketing Surveillance and Testing) are also in place for drugs in the distribution and sales stages. In addition, voluntary standards have been established to ensure that the quality of drugs is not compromised by temperature, humidity, light, or other factors at each stage of storage, shipment, and delivery.
In this way, drugs are delivered to patients only after they have passed strict regulations and standards at every stage. It can be said that the quality control of drugs is incomparably stricter than that of other products.
Chart/Column
38｜Various Tests in the Manufacturing Process of Pharmaceuticals
Source: White Paper on Health, Labour and Welfare, Ministry of Health, Labour and Welfare (2009 edition) (The figure shows various tests on tablets as an example).
MINI Column Regulatory Structure under the Pharmaceutical Affairs Law
Strict laws produce high quality drugs with efficacy, safety, and high reliability that everyone can use with peace of mind.
Source: Jiho Corporation, "Guidelines for the Manufacture and Sale of Pharmaceuticals 2008," p. 9
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