著者

廣野 善昭

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.2, no.2, pp.109-131, 2000 (Released:2006-07-29)

---

This report introduces GMP guidance and inspection activities in Yamaguchi Prefecture, Japan. There are 21 manufacturing sites in Yamaguchi Prefecture, Japan, in which 431 pharmaceuticals are being manufactured. Among them, 189 products are active pharmaceutical ingredients. Half of the active pharmaceutical ingredients manufactured are exported. There are 5 inspectors for GMP in Yamaguchi Prefecture. All of manufacturing sites and products are inspected during 5 years. Before conducting site inspection, thorough document surveillance is performed. That surveillance contains physical characteristics, manufacturing methods, critical processes, and critical quality attributes of the product. During document surveillance, ambiguous points are clarified by communication with manufacturers. After the document surveillance, usually 2 inspectors visit the manufacturing site for two days, and perform the inspection based on the preliminary established inspection check list. Observed results are classified to 1) suggestion, 2) item(s) to be further considered, 3) item(s) to be corrected. Results of these inspections have been introduced in this report by classified to the above three categories.