■統一用語［手順書］

ID	Japanese	English
1	SOP管理責任者	Person responsible for SOP management
2	安全確保業務責任者	person responsible for safety assurance operation
3	安全確保業務担当者	person in charge of safety assurance operation
4	医薬品製造管理者	manufacturing supervisor of pharmaceuticals
5	医薬品等安全管理責任者	safety control manager of pharmaceuticals
6	医薬品等総括製造販売責任者	marketing director of pharmaceuticals
7	医薬品等総括製造販売責任者	marketing director of pharmaceuticals, quasi-pharmaceutical products or cosmetics
8	医薬品等品質保証責任者	quality assurance manager of pharmaceuticals
9	医薬部外品等責任技術者	technical supervisor of quasi-pharmaceutical products
10	教育研修責任者	Person responsible for education and training
11	再生医療等製品品質保証責任者	quality assurance manager of regenerative medicine products
12	資料保存責任者	person responsible for archiving
13	自己点検責任者	person responsible for self-inspection
14	社長	president
15	受託安全管理実施責任者	entrusted safety control implementation supervisor
16	受託者	trustee
17	受託者等	trustees, etc.
18	製造業者等	manufacturers, etc.
19	製造販売業者等	marketing authorization holders
20	受託部門長	the head of trustee department
21	営業部門担当者	Key personnel from sales departments
22	委託者	Consignor
23	受託安全確保業務実施部門	contract safety assurance operation Implementation Department
24	プロジェクトチーム編成報告書	project team organization report
25	医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律	Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices
26	医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律施行規則	Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices
27	医薬品等適合性調査	compliance investigation of pharmaceuticals, quasi-pharmaceutical products or cosmetics
28	使用上の注意等	precautions for use
29	市販直後調査	EPPV
30	市販直後調査	excluding the early post-marketing phase vigilance
31	市販直後調査実施計画書	EPPV plan
32	製造販売後安全管理業務手順書等	operating procedures, etc. for post-marketing safety control activities
33	添付文書等	package inserts
34	添付文書等記載事項	matters to be indicated on package inserts
35	すり合わせ業務手順書	integrated operating procedure
36	措置実施結果報告書	Implementation of Measure and Results Report
37	業務マニュアル	operational manual
38	秘密保持契約書	confidentiality agreement
39	業務委受託基本契約書	basic contract for entrustment of business
40	業務委受託個別契約書	individual contract for entrustment of business
41	医薬品医療機器等法	Pharmaceutical and Medical Device Act
42	委受託契約書	Entrustment Agreement
43	医薬品、医薬部外品、化粧品及び医療機器の製造販売後安全管理の基準に関する省令	Ministerial Ordinance on Good Vigilance Practice for drugs, quasi-drugs, cosmetics, and medical devices
44	医薬品の臨床試験の実施の基準に関する省令	Ministerial Ordinance on Good Clinical Practice for Drugs
45	資料保存室	archiving room
46	SOP検討委員会	SOP review comittee
47	安全管理情報	safety management information
48	委託安全確保業務	entrusted safety assurance activities
49	医薬品等	pharmaceuticals, etc.
50	医薬品等適合性調査	compliance investigation of pharmaceuticals, quasi-pharmaceutical products or cosmetics
51	医療用医薬品	pharmaceuticals used with prescriptions or guidance
52	教育研修	education and training
53	継続教育研修	continuous education and training
54	再委託安全確保業務	further-entrusted safety assurance activities
55	指定製剤	designated preparations
56	自己点検	self-inspection
57	受託安全確保業務	contract safety assurance operation
58	成分同一物	pharmaceuticals with same components
59	製造販売後安全管理業務	Entrusting Post-Marketing Safety Control
60	追加的調査	additional investigation
61	電磁的方法	electronic or magnetic means
62	導入教育研修	education and training for introduction
63	被験薬	test drug
64	不具合等	failures, etc.
65	編入教育研修	education and training for admission
66	薬局医薬品等	pharmacy-only pharmaceuticals, etc.
67	受託業務	Entrusted Business
68	受託作業場所	the office where the business is carried out
69	代理人	deputy
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