著者

新田 博夫 酒井 達

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.8, no.2, pp.106-117, 2006 (Released:2008-02-01)

参考文献数

7

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There are no guidelines on the application of media-fill run to eye drops. General Information chapter in Japanese Pharmacopoeia serves as a reference. However, this chapter is used as guidance chapter for sterile drug products for general purposes. This study was conducted to investigate whether media-fill runs are performed in eye-drops manufacturers, and to analysis questionnaire results of the runs. The questionnaire results showed that media-fill runs for eye drops are periodically carried out, and sterile manufacturing of eye drops meets high sterility requirements. Spot contamination rarely found in eye drops might be due to the worst operation in the manufacturing process such as inappropriate actions of workers. The most important point for manufacturers of eye drops are that how to reduce the incidence of these actions.