著者

水田 泰一

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.4, no.1, pp.19-25, 2002 (Released:2006-07-28)

参考文献数

7

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API GMP approved at the ICHQ7A meeting in San Diego held in November 2000 is coming nearly toward the mandatory step in Japan. In this API GMP, the Design Qualification for pharmaceutical facilities is clearly described as well as IQ, OQ and PQ. However, there has been no specific description of Design Qualification provided for us the pharmaceutical industry, except for European stipulations. The Validation Standard Code of MHLW, for instance, requires Design Qualification by no means. Very few procedural monographs on such Design Qualification have been found at least in Japan. Thereupon, the author will demonstrate how well we could have the Design Qualification function in the course of validation on the basis of some relevant literatures available in hand and his own experience through pharmaceutical manufacturing with process validation. Especially, what is required to cover Design Qualification is to be noted in relation to such specifications determined as applicable conditions, performance factors and characteristic mechanisms necessary for equipment and facilities with the procedures for the first step qualification as Design Qualification before IQ, OQ and PQ. Some important regulatory guides and references for equipment design will finally be detailed for your easier understanding.

著者

水田 泰一

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.7, no.1, pp.25-37, 2005 (Released:2006-07-07)

参考文献数

20

著者

谷野 忠嗣 青木 義広 吉田 達守 鷲見 裕 水田 泰一

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.1, pp.19-27, 2000 (Released:2006-08-01)

参考文献数

8

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Fluidized-bed granulation has many operational parameters to be optimized in comparison with other simple wet granulation such as kneading or agitating. In addition, these parameters are not independent of each other: a change in one parameter often influences other parameters. Therefore, difficulties are sometime experienced with scale-up study of fluidized-bed granulation. It is a fact, however, that this granulation method has considerable merits to prepare highly compressible granules which can prevent capping incidents. It is experimentally known that tablets prepared by fluidized-bed granulation have usually higher hardness than those prepared by any other granulation methods. In this study, the authors discussed a scale-up and granule size control strategy on fluidized-bed granulation focusing on the moisture in granulation.