{"created":"2023-05-15T14:52:37.378539+00:00","id":71846,"links":{},"metadata":{"_buckets":{"deposit":"b30e8f54-5aa3-452d-96b6-4dd927fbe478"},"_deposit":{"created_by":1,"id":"71846","owners":[1],"pid":{"revision_id":0,"type":"depid","value":"71846"},"status":"published"},"_oai":{"id":"oai:repo.qst.go.jp:00071846","sets":["10:28"]},"author_link":["707404","707405","707407","707406","707413","707409","707411","707410","707414","707412","707408"],"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":"放射線医学総合研究所は、2013年4月より日本核医学会「PET薬剤製造施設認証監査機関」として指定を受け、10名の監査員（嘱託職員含む）体制で監査依頼を受託している。2015年3月末までに7施設の監査を実施し、全ての施設が認証を受けている。製造施設監査では、製造現場のWalk Through監査（実地調査）により、ホットラボ室の衛生管理や機器の適正使用を確認するが、この実地調査において、共通した間違えやすい衛生管理不備を確認した。例えば差圧計設置不備やHEPAユニットのバリデーション不備、流しやグレードAエリアの管理不備等が挙げられる。今回、監査結果報告書の中から、共通して見られた衛生管理の不備についてまとめ、対策について報告する。","subitem_description_type":"Abstract"}]},"item_10005_description_6":{"attribute_name":"会議概要（会議名, 開催地, 会期, 主催者等）","attribute_value_mlt":[{"subitem_description":"第55回日本核医学会学術総会","subitem_description_type":"Other"}]},"item_access_right":{"attribute_name":"アクセス権","attribute_value_mlt":[{"subitem_access_right":"metadata only access","subitem_access_right_uri":"http://purl.org/coar/access_right/c_14cb"}]},"item_creator":{"attribute_name":"著者","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"金子, いづみ"}],"nameIdentifiers":[{"nameIdentifier":"707404","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"金子, いづみ"}],"nameIdentifiers":[{"nameIdentifier":"707405","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"脇, 厚生"}],"nameIdentifiers":[{"nameIdentifier":"707406","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"岩隈, 佳寿子"}],"nameIdentifiers":[{"nameIdentifier":"707407","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"橋本, 裕輝"}],"nameIdentifiers":[{"nameIdentifier":"707408","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"藤林, 康久"}],"nameIdentifiers":[{"nameIdentifier":"707409","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"金子 いづみ","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"707410","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"脇 厚生","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"707411","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"岩隈 佳寿子","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"707412","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"橋本 裕輝","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"707413","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"藤林 康久","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"707414","nameIdentifierScheme":"WEKO"}]}]},"item_language":{"attribute_name":"言語","attribute_value_mlt":[{"subitem_language":"jpn"}]},"item_resource_type":{"attribute_name":"資源タイプ","attribute_value_mlt":[{"resourcetype":"conference object","resourceuri":"http://purl.org/coar/resource_type/c_c94f"}]},"item_title":"PET薬剤製造施設監査から見た施設共通の衛生管理の不備","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"PET薬剤製造施設監査から見た施設共通の衛生管理の不備"}]},"item_type_id":"10005","owner":"1","path":["28"],"pubdate":{"attribute_name":"公開日","attribute_value":"2015-11-09"},"publish_date":"2015-11-09","publish_status":"0","recid":"71846","relation_version_is_last":true,"title":["PET薬剤製造施設監査から見た施設共通の衛生管理の不備"],"weko_creator_id":"1","weko_shared_id":-1},"updated":"2023-05-15T19:46:42.732551+00:00"}