| 田霖,杨会英,孙会敏.药包材洁净环境相关法规和标准的对比研究[J].中国药事,2020,34(1):22-32 |
| 药包材洁净环境相关法规和标准的对比研究 |
| Comparative Study on Regulations and Standards of Clean Environment for Pharmaceutical Packaging Materials |
| 投稿时间：2019-06-25 |
| DOI：10.16153/j.1002-7777.2020.01.004 |
| 中文关键词: 药包材 洁净环境 法规 标准 |
| 英文关键词: pharmaceutical packaging materials clean environment laws and regulations standards |
| 基金项目: |
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| 中文摘要: |
| 目的：对比分析国内外药包材洁净环境现行相关法规和标准，找出目前我国药包材洁净环境存在的问题和需要改善的方面。方法：通过比较药包材洁净环境相关法规和标准的异同，发现我国法规和标准有待更新和提高之处，并参照行业现状，指出药包材洁净环境现存问题。结果：我国GMP与欧盟GMP总体保持一致，但其他的标准在一些参数的测试方法和标准上仍存在空白，我国药包材生产企业在开展日常监控和参数验证等工作中尚存缺陷。结论：我国药包材洁净环境相关法规和标准已经与国际接轨，一些条款仍需更新和完善。目前我国的药包材洁净环境仍存在一些问题，需要进一步推进相关法规和标准的执行，促进洁净环境整体质量的提升。 |
| 英文摘要: |
| Objective: To compare and analyze the current regulations and standards on the clean environment of pharmaceutical packaging materials at home and abroad, and to find out the existing problems and aspects for improvement in the clean environment of pharmaceutical packaging materials in China. Methods: By comparing the similarities and differences of the relevant regulations and standards, it is found that the regulations and standards in China are to be updated and improved, and the existing problems of the clean environment of the pharmaceutical packaging materials are pointed out with reference to the current situation of the industry. Results: Chinese GMP and the EU GMP are generally consistent, but there are still gaps in the test methods and quantity requirements of some parameters in some standards. There are still some defects in the routine monitoring and parameter verification of pharmaceutical packaging material manufacturers in China. Conclusion: The regulations and standards of clean environment for pharmaceutical packaging materials in China have been in line with international standards, but some provisions still need to be updated and improved. There are still some problems in the area of clean environment for drug packaging materials in China, so it is necessary to further promote the implementation of relevant laws and standards to promote the overall quality of clean environment. |
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