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要 約
FDA Guidance Document (旧:Guides #26)
FDA Guidance #26
承認済みNDA、またはANDAの変更 – CMC 情報
Guidance for Industry; Changes to an Approved NDA or ANDA. – CMC

I. 緒論、および背景 [Introduction and Background]                        
II. 報告のカテゴリー [Reporting Categories]             
III. 一般的要求事項 [General Requirements]                
IV. 製法変更の影響に関する評価 [Assessing the Effect of Manufacturing Changes]
 A.変更の影響の調査[Assessing the Effect of the Changes]
  1.規格への適合[Conformance to Specifications]
  2.追加の試験[Additional Testing]
 B.同等性[Equivalence]
 C.悪影響[Adverse Effect]
V.構成要素、および組成 [Components and Composition]
VI.製造所 [Manufacturing Sites]
 A.一般的考察[General Considerations]
 B.重要な変更[Major Changes](要事前承認補足申請[Prior Approval Supplement])
 C.中等度の変更[Moderate Changes] (実施中の変更・補足申請[Supplement – Changes Being Effected])
  1,30日以内に実施する変更・補足申請[Supplement – Changes Being Effected in 30 days]
  2.実施中の変更・補足申請[Supplement – Changes Being Effected]
 D.軽微な変更[Minor Changes (年次報告[Annual Report])
VII.製造プロセス [Manufacturing Process]
 A.一般的考察[General Considerations]
 B.重要な変更[Major Changes](要事前承認補足申請[Prior Approval Supplement])
 C.中等度の変更[Moderate Changes] (実施中の変更・補足申請[Supplement – Changes Being Effected])
  1,30日以内に実施する変更・補足申請[Supplement – Changes Being Effected in 30 days]
  2.実施中の変更・補足申請[Supplement – Changes Being Effected]
 D.軽微な変更[Minor Changes (年次報告[Annual Report])
VIII.規格 [Specifications]
 A.一般的考察[General Considerations]
 B.重要な変更[Major Changes](要事前承認補足申請[Prior Approval Supplement])
 C.中等度の変更[Moderate Changes] (実施中の変更・補足申請[Supplement – Changes Being Effected])
  1,30日以内に実施する変更・補足申請[Supplement – Changes Being Effected in 30 days]
  2.実施中の変更・補足申請[Supplement – Changes Being Effected]
 D.軽微な変更[Minor Changes (年次報告[Annual Report])
IX.容器蓋栓システム [Container Closure System]
 A.一般的考察[General Considerations]
 B.重要な変更[Major Changes](要事前承認補足申請[Prior Approval Supplement])
 C.中等度の変更[Moderate Changes] (実施中の変更・補足申請[Supplement – Changes Being Effected])
  1,30日以内に実施する変更・補足申請[Supplement – Changes Being Effected in 30 days]
  2.実施中の変更・補足申請[Supplement – Changes Being Effected]
 D.軽微な変更[Minor Changes (年次報告[Annual Report])
Ⅹ.表示 [Labeling]
 A.一般的考察[General Considerations]
 B.重要な変更[Major Changes](要事前承認補足申請[Prior Approval Supplement])
 C.中等度の変更[Moderate Changes] (実施中の変更補足申請[Supplement – Changes Being Effected])
 D.軽微な変更[Minor Changes (年次報告[Annual Report])
ⅩⅠ.その他の変更 [Miscellaneous Changes]
 A.重要な変更[Major Changes](要事前承認補足申請[Prior Approval Supplement])
 B.中等度の変更[Moderate Changes] (実施中の変更・補足申請[Supplement – Changes Being Effected])
  1,30日以内に実施する変更補足申請[Supplement – Changes Being Effected in 30 days]
  2.実施中の変更補足申請[Supplement – Changes Being Effected]
 C.軽微な変更[Minor Changes (年次報告[Annual Report])

ⅩⅡ.複数の変更 [Multiple Changes]

付属資料 A : 製造所[Manufacturing Sites]
付属資料 B : 作業のタイプ、およびCGMP査察[Type of Operation and CGMP
Inspections]
付属資料 C : CDER - 承認済医薬品[CDER - Approved Drug Products]
語彙 [Glossary]



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