Standards for manufacturing and quality control of pharmaceuticals

Japanese: 医薬品の製造と品質管理に関する基準 - いやくひんのせいぞうとひんしつかんりにかんするきじゅん
Standards for manufacturing and quality control of pharmaceuticals

...Therefore, when formulating drugs, efforts are made to ensure quality and improve efficacy, such as developing dosage methods, rapid, delayed, and sustained action, reducing side effects, improving bioavailability, and ease of administration by improving taste, odor, and irritation, as well as physicochemical stability, uniformity of content, dissolution, and prevention of the effects of external factors such as temperature, humidity, light, and microorganisms. Drugs are manufactured in drug formulation factories based on "good manufacturing practice (GMP)," which is a standard for the manufacture and quality control of drugs. GMP consists of three points: (1) minimizing human error, (2) preventing contamination and quality changes to drugs, and (3) designing a system to guarantee high quality, and high-level work standards are set for both soft and hard aspects. ...

*Some of the terminology used in the "Standards for Pharmaceutical Manufacturing and Quality Control" is listed below.

Source | Heibonsha World Encyclopedia 2nd Edition | Information

Japanese:

…それで製剤にあたっては用法の開発,速効性,遅効性,持効性,副作用の軽減,バイオアベイラビリティの改良,味・におい・刺激性の改良による服用のしやすさ,さらに物理化学的な安定性,含量均一性,溶出性,温度・湿度・光・微生物など外的因子による影響の防止など,有効性その他を高めるための品質確保にくふうがなされている。製剤工場では〈医薬品の製造と品質管理に関する基準good manufacturing practice(GMPと略記)〉に基づいて医薬品の製造がなされている。GMPの内容は,(1)人為的な誤りを最小限にする,(2)医薬品に対する汚染や品質変化を防止する,(3)高度な品質を保証するシステムを設計する,という3点で,いずれもソフト面,ハード面に分けて高度な作業基準が定められている。…

※「医薬品の製造と品質管理に関する基準」について言及している用語解説の一部を掲載しています。

出典|株式会社平凡社世界大百科事典 第2版について | 情報

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