著者

三川 正明

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.104-108, 2000 (Released:2006-07-29)

著者

三川 正明

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.93-98, 2000 (Released:2006-07-29)

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GMP for imported drugs (GMPI) has been issued in June and effective from August 1st in the last year. One of the most noteworthy issues is that the quality agreement with the foreign manufacturer has become a legal requirement. It is increasing to use the Third Party Manufacturer (TPM), in order to reduce business risks and total lifetime costs. All new TPM shall be assessed for GMP conformance and monitored for QA performance, in order to guarantee the product quality to be supplied. Quality agreement should be made as a part of business agreement, so that to guarantee the manufacturer's GMP conformance and mutual quality assurance on the product. As a sound business, the products and components or materials should be purchased from certified manufacturers and/or suppliers at the lowest life cycle cost. The lowest unit cost is not always necessary. The supplier should be reliable on their quality system, capable in supplying enough amount at the right time. Sound procurement system and TPM management will be required to assure the product quality and maintain a good supply chain. Quality agreement and continuous assessment on GMP compliance and QA performance of the manufacturers and/or suppliers should be a critical part of the procurement system and TPM management in the pharmaceutical companies.