著者

柳原 義彦

出版者

一般社団法人日本PDA製薬学会

雑誌

日本PDA学術誌 GMPとバリデーション (ISSN:13444891)

巻号頁・発行日

vol.5, no.1, pp.29-46, 2003 (Released:2006-07-14)

参考文献数

56

---

Conformity of drug products to their specifications alone is not sufficient to assure the quality of drugs to be administered to human subjects. In many European and North American countries, the necessity of validation of the drug manufacturing processes has been discussed and these countries have incorporated such validation into their regulation of drug products. Validation is now recognized as a global standard and has become an essential requirement for drug manufacture. For sterile drug products, specific methodology for conducting the validation has been established and accepted internationally. Regarding solid drug products for oral administration, however, there have been only a small number of studies on the validation of manufacturing processes and many drug manufacturers have difficulty in deciding how to carry out validation for oral solid preparations. Based on experience in GMP (Good Manufacturing Practice) inspection, the author investigated suitable methodology for the validation of ethical drugs, OTC (over-the-counter) drugs, and natural drug preparations/extract products in oriental medicine formulation. The results of the study were published as Osaka Prefecture's “Guidelines for Validation by Individual Drug Formulatron Groups,” which have facilitated the spread of validation without imposing a great burden on manufacturers. In this report, the author would like to explain the administrative background and the fundamental concept of the study.