| 查看: 2134 | 回复: 15 | |||
| 【奖励】 本帖被评价11次，作者wcg666增加金币 9 个 | |||
| 当前主题已经存档。 | |||
[资源]
【英文原版】 Pharmaceutical Process Validation
|
|||
|
http://wcg666.googlepages.com/PharmaceuticalProcessValidation.rar http://www.sendspace.com/file/bzac1k Contents Preface Contributors Introduction 1. Regulatory Basis for Process Validation John M. Dietrick and Bernard T. Loftus 2. Prospective Process Validation Allen Y. Chao, F. St. John Forbes, Reginald F. Johnson, and Paul Von Doehren 3. Retrospective Validation Chester J. Trubinski 4. Sterilization Validation Michael J. Akers and Neil R. Anderson 5. Validation of Solid Dosage Forms Jeffrey S. Rudolph and Robert J. Sepelyak 6. Validation for Medical Devices Toshiaki Nishihata 7. Validation of Biotechnology Processes Gail Sofer 8. Transdermal Process Validation Charlie Neal, Jr. 9. Validation of Lyophilization Edward H. Trappler 10. Validation of Inhalation Aerosols Christopher J. Sciarra and John J. Sciarra 11. Process Validation of Pharmaceutical Ingredients Robert A. Nash 12. Qualification of Water and Air Handling Systems Kunio Kawamura 13. Equipment and Facility Qualification Thomas L. Peither 14. Validation and Verification of Cleaning Processes William E. Hall 15. Validation of Analytical Methods and Processes Ludwig Huber 16. Computer System Validation: Controlling the Manufacturing Process Tony de Claire 17. Integrated Packaging Validation Mervyn J. Frederick 18. Analysis of Retrospective Production Data Using Quality Control Charts Peter H. Cheng and John E. Dutt 19. Statistical Methods for Uniformity and Dissolution Testing James S. Bergum and Merlin L. Utter 20. Change Control and SUPAC Nellie Helen Waterland and Christopher C. Kowtna 21. Process Validation and Quality Assurance Carl B. Rifino 22. Validation in Contract Manufacturing Dilip M. Parikh 23. Terminology of Nonaseptic Process Validation Kenneth G. Chapman 24. Harmonization, GMPs, and Validation Alfred H. Wachter [ Last edited by wcg666 on 2006-12-17 at 10:56 ] |
回复此楼» 收录本帖的淘帖专辑推荐
 药物合成 |
» 猜你喜欢
各位道友，我要去昆明玩几天，回来见。
已经有8人回复
-
售SCI一区T0P文章，我:8O.55.1.O.5.4,科目齐全,可+急
已经有4人回复
-
售SCI文章，我:8O5.5.1.O.54,科目齐全,可+急
已经有5人回复
-
售SCI一区T0P文章，我:8.O55.1.O.54,科目全,可十急
已经有7人回复
-
售SCI一区文章，我:8O5.5.1.O5.4,科目全,可伽急
已经有5人回复
-
售SCI一区T0P文章，我:8.O.55.1.O.54,科目齐全,可+急
已经有8人回复
-
咱们一起用铁证分析2026国家社科基金中标与否
已经有22人回复
-
是这周出结果还是下周出结果？
已经有4人回复
-
售SCI一区文章，我:8.O.55.1.O.54,科目齐全,可伽急
已经有5人回复
-
欢迎发来filecode的Mz6后的代码验证其规律
已经有49人回复
2楼2006-12-10 22:14:57
4楼2006-12-11 08:12:03
5楼2006-12-11 08:47:57
7楼2006-12-11 10:51:08
8楼2006-12-11 19:40:34
9楼2006-12-12 15:59:57
10楼2006-12-12 20:29:57
12楼2006-12-13 11:32:26
13楼2006-12-13 15:05:06
14楼2006-12-13 23:29:31
简单回复
胶囊3楼
2006-12-10 23:34
回复
calla6楼
2006-12-11 08:49
回复
凌云壮志11楼
2006-12-12 23:40
回复
dsonghao15楼
2006-12-22 16:41
回复
gxl198316楼
2006-12-22 20:54
回复
