第十七条洁净室(区)的温度和相对湿度应与药品生产工艺要求相适应。
Article 17: the temperature and relative humidity in the clean rooms (areas) shall comply with the requirements of the production process.
目的改进珍菊降压片的生产工艺,保证药品质量。
To improve the manufacture technology of Zhenju Jiangya Tablet, and ensure the quality of the drug.
药品生产企业改变影响药品质量的生产工艺的,必须报原批准部门审核批准。
When drug manufacturers make any change in the production process that may affect the drug quality, they shall submit the matter for examination and approval to the original approval authority.
目的:为了提高银杏叶水提液的澄清度和药品质量,优化生产工艺。
AIM: in order to improve the clarity and quality of Ginkgo leaf water-extraction solution, and optimize the production process.
药品生产企业改变影响药品质量的生产工艺的,必须报原批准部门审核批 准。
When drug manufacturers make any change in the production process that may affect the drug quality, they shall submit the change to the original authority for reviewing and approval.
药品生产企业改变影响药品质量的生产工艺的,必须报原批准部门审核批 准。
When drug manufacturers make any change in the production process that may affect the drug quality, they shall submit the change to the original authority for reviewing and approval.
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