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Validation of Active Pharmaceutical Ingredients 第1 版
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Validation of Active Pharmaceutical Ingredients
Much has happened in the area of bulk pharmaceutical good manufacturing practice (GMP) and validation since the first publication of Validation of Active Pharmaceutical Ingredients. Revised, updated, and expanded, this second edition includes new chapters addressing postapproval changes, technology transfer, international cGMP guidelines/FDA guidance progress, and facility inspection issues. The basic philosophy and principles of GMP and validation have not changed, but new terminology had been introduced, and old terminology had been better defined, improving the understanding of related concepts and principles. The book gives you a working knowledge of the regulatory process that will facilitate your organization's compliance with regulations.
618 pages
| メディア | 書籍 Hardcover Book (ハードカバー付きの本) |
| リリース済み | 2001年12月31日 |
| ISBN13 | 9781574911190 |
| 出版社 | Taylor & Francis Inc |
| ページ数 | 618 |
| 寸法 | 150 × 220 × 20 mm · 1,30 kg |
| 言語 | 英語 |
| 編集者 | Berry, Ira R. |
| 編集者 | Harpaz, Daniel (Harpaz Consulting Services, Suffern, New York, USA) |
