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要 約
FDA Guidance Document (旧:Guides #56)
FDA Guidance #56
IND Phase 1 におけるCGMP適合性のためのアプローチ
Draft Guidance:Guidance for Industry INDs:Approaches to complying with CGMP during Phase 1)

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research
Center for Biological Evaluation and Research
January 2006
CGMP

Draft Guidance
Guidance for Industry

INDs : Approaches to complying with CGMP during Phase 1
IND Phase 1におけるCGMP適合のためのアプローチ

目次[Table of Contents]
I.緒論[Introduction]
II.背景[Background]
III.適用範囲[Scope]
IV.法規による要求事項[Statutory and Regulatory Requirements]
V.法律に適合するための推奨事項[Recommendations for complying with the Statute]
 A.人員[Personnel]
 B.品質管理機能[Quality Control Function]
 C.施設、および機器[Facility and Equipment]
 D.成分の管理[Control of Components]
 E.生産、および文書[Production and Documentation]
 F.試験管理[Laboratory Controls]
  1.試験[Testing]
  2.安定性[Stability]
 G.容器・蓋栓、および表示[Container Closure and Labeling]
 H.流通[Distribution]
 I.記録の保管[Recordkeeping]
VI.特殊な生産の状況[Special Production Situations]
 A.スクリーニング試験/微量製剤製造業者[Screening Studies/Microdose Producers]
 B.複数製品向け施設[Multi-Product Facilities]
 C.生物学的製剤、およびバイオ技術製品[Biological and Biotechnological Products]
  1. 一般的配慮[General Considerations]
  2. 複数製品向け施設[Multi-Product Facility]
  3. 遺伝子治療、および細胞療法製品[Gene Therapy and Cellular Therapy Products]]
  4. 複数バッチ向け製造業者[Multi-Batch Producers]
 D. 無菌製剤/無菌操作による製品[Sterile Products/Aseptically Processed Products]

語彙[Glossary]

参考資料[References]



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