产品生产和质量 Drug production and quality 企业文化和社会责任 Corporate culture and social responsibility ..
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Control the quality of drug products during production to ensure that they meet standards of potency, purity, uniformity, stability and safety.
在生产过程中控制药物产品的质量，以确保它们符合效价，纯度，均匀性，稳定性和安全标准。
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.
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。
Results and Conclusion: Deviation analysis is necessary for quality assurance system in drug production.
结果与结论：在药品生产中，偏差分析是质量保证体系不可或缺的组成部分。
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