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Table of Contents
目次
第1章 微生物試験法の国際調和に向けた課題と，今後の三局の動向
1. 微生物試験法の重要牲を認識する前提としての医薬品製造設備の管理/ 1
2. ICHにおける"Validation"と"Qualification"（適格性評価）との違いの定義/ 5
3. 微生物試験の重要性とその必要性の背景/ 6
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- Material Type
- 図書
- ISBN
- 978-4-86428-000-6
- Title Transcription
- 3キョク タイオウ GMP ニ オケル ビセイブツ シケン カンリ
- Publication, Distribution, etc.
- Publication Date
- 2010.7
- Publication Date (W3CDTF)
- 2010
- Extent
- 147p
- Size
- 27cm
- Place of Publication (Country Code)
- JP