{"@context":{"@vocab":"https://cir.nii.ac.jp/schema/1.0/","rdfs":"http://www.w3.org/2000/01/rdf-schema#","dc":"http://purl.org/dc/elements/1.1/","dcterms":"http://purl.org/dc/terms/","foaf":"http://xmlns.com/foaf/0.1/","prism":"http://prismstandard.org/namespaces/basic/2.0/","cinii":"http://ci.nii.ac.jp/ns/1.0/","datacite":"https://schema.datacite.org/meta/kernel-4/","ndl":"http://ndl.go.jp/dcndl/terms/","jpcoar":"https://github.com/JPCOAR/schema/blob/master/2.0/"},"@id":"https://cir.nii.ac.jp/crid/1390282679448780416.json","@type":"Article","productIdentifier":[{"identifier":{"@type":"DOI","@value":"10.11347/pda.17.5"}},{"identifier":{"@type":"NAID","@value":"130005092260"}},{"identifier":{"@type":"URI","@value":"https://search.jamas.or.jp/link/ui/2016240891"}}],"dc:title":[{"@language":"ja","@value":"非無菌製剤の製造環境管理に関する研究<br/>―リスクに基づく維持/管理手法の構築―"},{"@language":"en","@value":"Manufacturing Environmental Control for Non-sterile Pharmaceutical Dosage Forms Establishment of Risk-based Control and Maintenance Systems"}],"dc:language":"ja","description":[{"type":"abstract","notation":[{"@language":"en","@value":"This publication has been prepared to express a sound and practical view on the better manufacturing environmental control for non-sterile pharmaceutical dosage forms, which has been discussed for several years by a special working group members of Kansai Study Group (KSG) accredited as one of the committees in Parenteral Drug Association (PDA) Japan Chapter. The opinions proposed or advanced in the document are formed for the purpose of furnishing a beneficial and valuable guide with advisability to any persons or organizations concerned in establishing appropriate manufacturing control systems for quality products.<br>   The leading topics discussed among the WG are focused on the prevention against cross-contamination and foreign matter ingress, and categorized into five subjects composed of HVAC systems, premises, gowning, cleaning, and cleanliness standards. Constructive and earnest discussion therein has been devoted to the key processes, wherein considerable amounts of powders are handled for the successful operations of weighing, granulation, mixing, and tableting. In the expectation of good usage, many of the principles and the way of thinking presented hereupon, in particular can be applied or rearranged to a wide spectrum of other manufacturing processes for various dosage forms of non-sterile drug products.<br>"}],"abstractLicenseFlag":"disallow"}],"creator":[{"@id":"https://cir.nii.ac.jp/crid/1420001326217402496","@type":"Researcher","personIdentifier":[{"@type":"KAKEN_RESEARCHERS","@value":"10553034"},{"@type":"NRID","@value":"1000010553034"},{"@type":"NRID","@value":"9000411106735"},{"@type":"NRID","@value":"9000019116709"},{"@type":"NRID","@value":"9000399251749"},{"@type":"NRID","@value":"9000412109888"},{"@type":"NRID","@value":"9000403975950"},{"@type":"NRID","@value":"9000258298668"},{"@type":"NRID","@value":"9000301714016"},{"@type":"NRID","@value":"9000399790125"},{"@type":"NRID","@value":"9000391709872"},{"@type":"NRID","@value":"9000254866816"},{"@type":"NRID","@value":"9000409618643"},{"@type":"NRID","@value":"9000411981975"},{"@type":"RESEARCHMAP","@value":"https://researchmap.jp/k-hokkaido"}],"foaf:name":[{"@language":"ja","@value":"井上 敬介"},{"@language":"en","@value":"INOUE Keisuke"}],"jpcoar:affiliationName":[{"@language":"en","@value":"Takeda Pharmaceutical Company Limited"},{"@language":"ja","@value":"武田薬品工業株式会社"}]},{"@id":"https://cir.nii.ac.jp/crid/1410282679448780290","@type":"Researcher","personIdentifier":[{"@type":"NRID","@value":"9000301714025"}],"foaf:name":[{"@language":"ja","@value":"浦山 由巳"},{"@language":"en","@value":"URAYAMA Yoshimi"}],"jpcoar:affiliationName":[{"@language":"en","@value":"Chiyoda Corporation"},{"@language":"ja","@value":"千代田化工建設株式会社"}]},{"@id":"https://cir.nii.ac.jp/crid/1410282679448780423","@type":"Researcher","personIdentifier":[{"@type":"NRID","@value":"9000301714026"}],"foaf:name":[{"@language":"ja","@value":"上久木田 務"},{"@language":"en","@value":"KAMIKUKITA Tsutomu"}],"jpcoar:affiliationName":[{"@language":"en","@value":"Towa Pharmaceutical Co., Ltd."},{"@language":"ja","@value":"東和薬品株式会社"}]},{"@id":"https://cir.nii.ac.jp/crid/1410282679448780424","@type":"Researcher","personIdentifier":[{"@type":"NRID","@value":"9000301714027"}],"foaf:name":[{"@language":"ja","@value":"白井 俊光"},{"@language":"en","@value":"SHIRAI Toshimitsu"}],"jpcoar:affiliationName":[{"@language":"en","@value":"Kondoh Industries Limited"},{"@language":"ja","@value":"近藤工業株式会社"}]},{"@id":"https://cir.nii.ac.jp/crid/1410282679448780295","@type":"Researcher","personIdentifier":[{"@type":"NRID","@value":"9000301714028"}],"foaf:name":[{"@language":"ja","@value":"白木澤 治"},{"@language":"en","@value":"SHIROKIZAWA Osamu"}],"jpcoar:affiliationName":[{"@language":"en","@value":"Life Scientia Limited"},{"@language":"ja","@value":"ライフサイエンティア株式会社"}]},{"@id":"https://cir.nii.ac.jp/crid/1410282679448780291","@type":"Researcher","personIdentifier":[{"@type":"NRID","@value":"9000301714029"}],"foaf:name":[{"@language":"ja","@value":"杉山 篤央"},{"@language":"en","@value":"SUGIYAMA Tokuhito"}],"jpcoar:affiliationName":[{"@language":"en","@value":"Sumitomo Dainippon Pharma Co., Ltd."},{"@language":"ja","@value":"大日本住友製薬株式会社"}]},{"@id":"https://cir.nii.ac.jp/crid/1410282679448780418","@type":"Researcher","personIdentifier":[{"@type":"NRID","@value":"9000301714030"}],"foaf:name":[{"@language":"ja","@value":"須藤 眞生"},{"@language":"en","@value":"SUDOH Masao"}],"jpcoar:affiliationName":[{"@language":"en","@value":"Ono Pharmaceutical Co., Ltd."},{"@language":"ja","@value":"小野薬品工業株式会社"}]},{"@id":"https://cir.nii.ac.jp/crid/1410282679448780419","@type":"Researcher","personIdentifier":[{"@type":"NRID","@value":"9000301714031"}],"foaf:name":[{"@language":"ja","@value":"田中 広徳"},{"@language":"en","@value":"TANAKA Hironori"}],"jpcoar:affiliationName":[{"@language":"en","@value":"MSD K.K."},{"@language":"ja","@value":"MSD 株式会社"}]},{"@id":"https://cir.nii.ac.jp/crid/1410282679448780288","@type":"Researcher","personIdentifier":[{"@type":"NRID","@value":"9000301714032"}],"foaf:name":[{"@language":"ja","@value":"田原 繁広"},{"@language":"en","@value":"TAHARA Shigehiro"}],"jpcoar:affiliationName":[{"@language":"en","@value":"CM Plus Singapore Pte. Ltd."},{"@language":"ja","@value":"CM Plus SINGAPORE PTE. LTD."}]},{"@id":"https://cir.nii.ac.jp/crid/1410282679448780416","@type":"Researcher","personIdentifier":[{"@type":"NRID","@value":"9000301714017"}],"foaf:name":[{"@language":"ja","@value":"那須川 真澄"},{"@language":"en","@value":"NASUKAWA Masumi"}],"jpcoar:affiliationName":[{"@language":"en","@value":"CM Plus Corporation"},{"@language":"ja","@value":"株式会社シーエムプラス"}]},{"@id":"https://cir.nii.ac.jp/crid/1410282679448780289","@type":"Researcher","personIdentifier":[{"@type":"NRID","@value":"9000301714018"}],"foaf:name":[{"@language":"ja","@value":"平原 茂人"},{"@language":"en","@value":"HIRABARA Shigeto"}],"jpcoar:affiliationName":[{"@language":"en","@value":"Hirabara Engineering Service Ltd."},{"@language":"ja","@value":"平原エンジニアリングサービス株式会社"}]},{"@id":"https://cir.nii.ac.jp/crid/1410282679448780420","@type":"Researcher","personIdentifier":[{"@type":"NRID","@value":"9000301714019"}],"foaf:name":[{"@language":"ja","@value":"堀江 匠"},{"@language":"en","@value":"HORIE Taku"}],"jpcoar:affiliationName":[{"@language":"en","@value":"Taikisha Ltd."},{"@language":"ja","@value":"株式会社大気社"}]},{"@id":"https://cir.nii.ac.jp/crid/1410282679448780293","@type":"Researcher","personIdentifier":[{"@type":"NRID","@value":"9000301714020"}],"foaf:name":[{"@language":"ja","@value":"光吉 浩"},{"@language":"en","@value":"MITSUYOSHI Hiroshi"}],"jpcoar:affiliationName":[{"@language":"en","@value":"Shionogi & Co., Ltd."},{"@language":"ja","@value":"塩野義製薬株式会社"}]},{"@id":"https://cir.nii.ac.jp/crid/1410282679448780417","@type":"Researcher","personIdentifier":[{"@type":"NRID","@value":"9000301714021"}],"foaf:name":[{"@language":"ja","@value":"三原 宏美"},{"@language":"en","@value":"MIHARA Hiromi"}],"jpcoar:affiliationName":[{"@language":"en","@value":"Sumika Chemical Analysis Service, Ltd."},{"@language":"ja","@value":"株式会社住化分析センター"}]},{"@id":"https://cir.nii.ac.jp/crid/1410282679448780292","@type":"Researcher","personIdentifier":[{"@type":"NRID","@value":"9000301714022"}],"foaf:name":[{"@language":"ja","@value":"宮本 貴之"},{"@language":"en","@value":"MIYAMOTO Takayuki"}],"jpcoar:affiliationName":[{"@language":"en","@value":"Taikisha Ltd."},{"@language":"ja","@value":"株式会社大気社"}]},{"@id":"https://cir.nii.ac.jp/crid/1410282679448780294","@type":"Researcher","personIdentifier":[{"@type":"NRID","@value":"9000301714023"}],"foaf:name":[{"@language":"ja","@value":"村上 大吉郎"},{"@language":"en","@value":"MURAKAMI Daikichiro"}],"jpcoar:affiliationName":[{"@language":"en","@value":"Hirabara Engineering Service Ltd."},{"@language":"ja","@value":"平原エンジニアリングサービス株式会社"}]},{"@id":"https://cir.nii.ac.jp/crid/1410282679448780422","@type":"Researcher","personIdentifier":[{"@type":"NRID","@value":"9000301714024"}],"foaf:name":[{"@language":"ja","@value":"山中 邦昭"},{"@language":"en","@value":"YAMANAKA Kuniaki"}],"jpcoar:affiliationName":[{"@language":"en","@value":"Freund Corporation"},{"@language":"ja","@value":"フロイント産業株式会社"}]}],"publication":{"publicationIdentifier":[{"@type":"PISSN","@value":"13444891"},{"@type":"EISSN","@value":"18811728"}],"prism:publicationName":[{"@language":"en","@value":"PDA Journal of GMP and Validation in Japan"},{"@language":"ja","@value":"日本PDA学術誌 GMPとバリデーション"},{"@language":"en","@value":"PDA J. GMP Valid. Jpn"},{"@language":"ja","@value":"日本ＰＤＡ学術誌　ＧＭＰとバリデーション"}],"dc:publisher":[{"@language":"en","@value":"Parenteral Drug Association Japan Chapter"},{"@language":"ja","@value":"一般社団法人日本PDA製薬学会"}],"prism:publicationDate":"2015","prism:volume":"17","prism:number":"1","prism:startingPage":"5","prism:endingPage":"93"},"url":[{"@id":"https://search.jamas.or.jp/link/ui/2016240891"}],"availableAt":"2015","foaf:topic":[{"@id":"https://cir.nii.ac.jp/all?q=Non-sterile%20Pharmaceutical%20Dosage%20Forms","dc:title":"Non-sterile Pharmaceutical Dosage Forms"},{"@id":"https://cir.nii.ac.jp/all?q=Manufacturing%20Environmental%20Control","dc:title":"Manufacturing Environmental Control"},{"@id":"https://cir.nii.ac.jp/all?q=Good%20Manufacturing%20Practice%20(GMP)","dc:title":"Good Manufacturing Practice (GMP)"},{"@id":"https://cir.nii.ac.jp/all?q=Risk%20Based%20Approach","dc:title":"Risk Based Approach"},{"@id":"https://cir.nii.ac.jp/all?q=Science%20Based%20Approach","dc:title":"Science Based Approach"}],"dataSourceIdentifier":[{"@type":"JALC","@value":"oai:japanlinkcenter.org:2000698692"},{"@type":"CIA","@value":"130005092260"}]}