| 摘要: |
| 兽药GMP认证工作主要是对人员、硬件与软件三大要素和验证、规程和记录三大重点工作进行考核与检查。其中，硬件是基础，软件是重点，人员是关键。记录是GMP认证的基础性工作，必需真实、详细；规程是兽药生产的规范性文件和行动指南，应规范、合理，可操作性强；而验证则是GMP认证工作的精髓和重中之重，各项规程及标准等都必须通过验证。 |
| 关键词: 兽药GMP 检查验收 质量管理 |
| DOI： |
| 投稿时间：2011-08-29修订日期：2011-10-14 |
| 基金项目: |
|
| TheCommon Problem in GMP Inspection of Veterinary Drugs |
| wulilong |
| (Hunan province institute of veterinary drug and feed control) |
| Abstract: |
| Veterinary drugs GMP inspection mainly covers examining and checking of three principle points including personnel, hardware and software, and also three key work including validation, protocols and records. Of them, hardware is fundamental, software is important and personnel are critical. Various records are the fundamental work in GMP inspection, to be true and detailed. Various protocols are standard documents and behavior guidance in manufacturing of veterinary drugs. The validation is the critical points of key works in GMP inspection, to be normative and reasonable, and strong operability. All protocols and standards must pass the validation. |
| Key words: Veterinary drugs GMP inspection Quality control |
