著者

田中 喜久

出版者

社団法人 日本消化器内視鏡学会

雑誌

日本内視鏡学会誌 (ISSN:18845711)

巻号頁・発行日

vol.9, no.4, pp.418-421, 1967-12-01 (Released:2011-02-23)

参考文献数

7

著者

大竹 良知 田中 喜久 佐藤 栄治

出版者

愛知県農業総合試験場

雑誌

愛知県農業総合試験場研究報告 (ISSN:03887995)

巻号頁・発行日

no.17, pp.p200-206, 1985-10

著者

田中 喜久夫

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.1, no.2, pp.83-93, 1999 (Released:2006-08-03)

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Shizuoka Prefecture is the second largest prefecture of pharmaceutical production on the valve basis in Japan. Guidance Office of Pharmaceutical Affairs, Department of Health and Welfare has various functions such as inspection guidance and training program for industries. Concerning the GMP issues, there are two groups of field inspection consisting of 2 inspectors each in Shizuoka Prefectural Government. They spent 175 days in a year for field inspections as a rule. There are 59 pharmaceutical manufacturing facilities to which GMP is applied in Shizuoka Prefecture, among which 18 facilities are for manufacturing sterile products, 18 facilities are for manufacturing active pharmaceutical ingredients only, and other manufacturing facilities are for other dosage forms such as solid dosage form and external use. In the year of 1998, 266 cases were observed as objectionable, although some of which were minor ones or only recommendations. Among these 266 observations, 246 (92.5%) were concerning manufacturing control and management including the implementation of validation, and 19 were concerning equipments and construction features. These observations have been analyzed in details to show in what parts of GMP were week and should be improved hereafter. Followings are major parts which were observed as to be improved; (1) responsible persons should perform their job by themselves, (2) keen attention should be paid to the consistency among SOP, actual practice and manufacturing records, (3) change and/or omission of the written procedure should be performed only after official authorized approval, of the written procedure, (4) deficiencies were observed in lack of such records as cleaning, calibration, comparison between the standard yield and actual yield, trend analysis of % of rejected product by process inspection, and storage of raw data, (5) retest rule should be established in every case, (6) some deviations were observed in storage condition of products, raw materials and reference standards for laboratory test use, (7) complaint handling procedure and training procedure should be more clearly established to facilitate and secure the practice, (8) some inadequacies were observed in operation room condition, preparation vessel, and laboratory equipments.