以下为句子列表：
英文: Any substances required for operation, such as lubricants or coolants, shall not come into contact with components, drug product containers, closures, in-process materials, or drug products so as to alter the safety, identity, strength, quality, or purity
中文: 操作所需的所有物质，例如润滑油、制冷剂，都不能和成分、药物容器、胶塞、中间生成物或者药物接触，以确保不改变药物的安全性、同一性、活性、质量或纯度，使其不满足官方或者其他既定要求。
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英文: Equipment and utensils shall be cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other estab
中文: 设备也器具要适当定期清洗，维护和清洁以防止出现故障或污染，以确保不改变药物的安全性、同一性、活性、质量或纯度，使其不满足官方或者其他既定要求。
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英文: Equipment shall be constructed so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the
中文: 接触组分、中间产物或者药品的设备表面必须不和药物反应，没有异物脱落，不吸附药物，以确保不改变药物的安全性、同一性、活性、质量或纯度，使其不满足官方或者其他既定要求。
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英文: The Senior Site Quality Manager of the Company Site or External Manufacturing Unit that releases the Active Pharmaceutical Ingredient or Drug Product is responsible for ensuring that an Annual Product Review and the report for the Annual Product Review ar
中文: 负责放行原料药或药品的公司或外部生产工厂的高层质量管理人员，有责任确保完成年度产品审核以及年度产品审核的报告。
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