| 摘要: |
| 本文从质量管理理念的发展与新版兽药GMP要求出发，剖析了目前兽药生产企业在质量管理理念、质量管理和质量控制力量及水平、GMP管理文件的执行、风险意识等方面的问题，提出了兽药生产企业应从强化质量管理理念、重视发挥QA和QC的作用、针对新版GMP要点和难点切实开展工作和真正建立风险管理机制方面切实采取措施，希望能借此帮助兽药生产企业完善质量管理，保证兽药GMP要求落实到位，推动兽药行业的高质量发展。 |
| 关键词: 兽药 质量管理 薄弱环节 措施 |
| DOI： |
| 投稿时间：2023-11-17修订日期：2023-12-07 |
| 基金项目:药物靶标与新兽药创制 |
|
| Weakness analysis of quality management on the implementation of new version GMP by Vet Drug Manufactures |
|
| (China Institute of Veterinary Drug Control) |
| Abstract: |
| Based on the quality management concept and requirements of the new version veterinary drug GMP, this article analyzed and identified problems on awareness of quality management, competency of quality management and quality contriol, implementation of the GMP files and risk perception, it is proposed that the manufactures should strengthen the quality management, further enhance QA and QC roles, take the effective measures according to the key and challenging points of the new version GMP,and set up the risk management mechanism. It is expected to support the industry to improve quality management, ensure the implementation of veterinary drug GMP requirements, and promote the high-quality development of the veterinary drug industry. |
| Key words: veterinary drug quality management weakness measures |
