{"created":"2023-05-15T14:52:38.998122+00:00","id":71883,"links":{},"metadata":{"_buckets":{"deposit":"3cd803e4-1ecd-42df-8645-921097593b63"},"_deposit":{"created_by":1,"id":"71883","owners":[1],"pid":{"revision_id":0,"type":"depid","value":"71883"},"status":"published"},"_oai":{"id":"oai:repo.qst.go.jp:00071883","sets":["10:28"]},"author_link":["707940","707932","707930","707947","707942","707939","707943","707944","707936","707946","707926","707929","707935","707941","707927","707933","707931","707937","707934","707938","707928","707945"],"item_10005_date_7":{"attribute_name":"発表年月日","attribute_value_mlt":[{"subitem_date_issued_datetime":"2015-11-06","subitem_date_issued_type":"Issued"}]},"item_10005_description_5":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"放医研では、治験薬評価のために使用する11C標識薬剤製造について日本核医学会PET薬剤製造施設認証を受け、学会GMPに準拠した11C標識薬剤を毎週継続的に製造及び提供を行っている。学会GMP準拠製造管理では、製造及び品質検査に対する信頼性や適切な無菌操作等に関わる品質管理技術が不可欠である。そこで今回放医研が行っている品質管理技術について紹介する。製造では、製造トラブルおよび交差汚染防止のために、専用の銀トリフレートカラム、合成装置ユニット、分取HPLCカラム、ガラス器具を使用した。また器具はバリデーションにより規定した洗浄方法を用いて洗浄を行った。次に品質検査では、品質検査の信頼性向上のため、製造日のPET薬剤試験検査前に再現性を確認するためシステム適合性試験を行った。無菌操作については、無菌操作認定を受けた作業者だけがクリーンブース等のグレードAでの無菌操作を行うことにより、現在まで作業中の環境モニタリングで逸脱は発生しなかった。このような品質保証を達成するための細かい注意点と工夫について詳細を紹介する。","subitem_description_type":"Abstract"}]},"item_10005_description_6":{"attribute_name":"会議概要（会議名, 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