| 李乐,赵红菊,杨牧,由东,杨祝仁,刘知音.中药饮片生产企业实施GMP存在的问题[J].中国药事,2017,(6):604-607 |
| 中药饮片生产企业实施GMP存在的问题 |
| Problems in Implementation of GMP in Chinese Herbal Pieces Production Enterprises |
| 投稿时间：2017-02-04 |
| DOI：10.16153/j.1002-7777.2017.06.004 |
| 中文关键词: 中药饮片 药品生产质量管理规范 跟踪检查 缺陷分析 |
| 英文关键词: Chinese herbal pieces GMP follow-up inspection defects analysis |
| 基金项目: |
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| 中文摘要: |
| 目的：对我省中药饮片生产企业GMP跟踪检查过程中发现的缺陷情况进行汇总，供业内借鉴和参考。方法：对跟踪检查过程中发现的有代表性的缺陷进行归类与分析。结果与结论：企业在持续执行GMP规定过程中均不同程度的存在缺陷，包括对GMP部分章节条款理解不充分、执行不到位等。中药饮片生产企业应持续改进质量管理体系，更加有效地控制产品的潜在质量风险。 |
| 英文摘要: |
| Objective: To summarize the defects found during the GMP follow-up inspection of Chinese herbal pieces production enterprises in Liaoning Province and use them as references for the industry. Methods: The typical defects found during the GMP follow-up inspection were classified and analyzed. Results and Conclusion: There were different degrees of defects in the continuous implementation of GMP, including poor understanding of some provisions of the Drug GMP and inadequate implementation. Chinese herbal pieces production enterprises should continuously improve their quality management system so as to control the potential quality risk of products more effectively. |
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