是否有处理进货原料的书面程序？
A written procedure on handling of incoming materials exists?
是否有将相应的变更融入公司程序的书面程序？
Is a documented process exist for incorporating changes in legislation, standards, safety etc, into the factory's procedures?
FDA要求公司具有验证清洗过程的常规书面程序。
FDA expects firms to have written general procedures on how cleaning processes will be validated.
FDA要求公司具有验证清洗过程的常规书面程序。
FDA a expects firms to have written general procedures on how cleaning processes will be validated.
您公司有风险评估的书面程序吗，尤其是(相关的)决策程序？
Does your company have a written risk assessment procedure, especially for the decision making procedure?
你公司解释说你们缺少一个描述实验室确认与校准的书面程序。
Your firm acknowledged that your firm lacks a written procedure describing the qualification and calibration of the laboratory equipment.
如果将未打印批号的包装材料退库，则应按书面程序规定执行。
A documented procedure should be followed if uncoded printed materials are returned to stock.
制造业者应建立并维持各项书面程序，以执行矫正与预防措施。
The manufacturer shall establish and maintain procedures for implementing corrective and preventive action.
制造业者应建立并维持书面程序，以确保所购产品符合规定要求。
The manufacturer shall establish and maintain documented procedures to ensure that purchased product conform to specified requirements.
对主产品和控制记录的准备应有书面程序并且应遵循这样的书面程序。
The preparation of master production and control records shall be described in a written procedure and such written procedure shall be followed.
由于矫正与预防措施所产生的书面程序之变更，组织应实施并记录之。
The organization shall implement and record any changes in the documented procedures resulting from corrective and preventive action.
在书面程序中，大多数成员需要给出积极或默许的意见，以使决策有效。
In a written procedure, a majority of members needs to give their active or tacit approval to render the decision valid.
第七十九条药品生产企业应建立药品退货和收回的书面程序，并有记录。
Article 79: a drug manufacturing enterprise shall establish the written procedures and records of drug return and recall.
贵公司是否有关于设备和车辆的预防检测、维修保养等方面的书面程序？
Is there a documented programme for preventive inspection and maintenance of equipment and vehicles?
有一些不好的书面程序，但没有提供和深入的解释，如何统一和维护系统。
There were some poorly written procedures but nothing that provided and in-depth explanation of how to align and maintain the system.
工厂是否有书面程序可用来确认从其他供应商所取得的资讯是正确且准时的？
Does your factory have written procedures to make sure that information received from foreign suppliers is reported accurately and timely?
此外，cGMP还要求按照书面程序对每个药品的质量标准每年至少评估一次。
Moreover, CGMPs require written procedures for evaluating the quality standards of each drug product at least annually (211.180).
书面程序应界定为规划和执行稽核之责任与要求，并应记录和报告结果（见4.2.4）
The Responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure.
FDA要求公司具有详细地记录设备各种零件的清洗过程的书面程序(SOP ' s)。
FDA a expects firms to have written procedures (SOP's) detailing the cleaning processes used for various pieces of equipment.
如果是的，客户一定有所有的下列各项，质量管理代表，质量认证手册及相关的书面程序。
If Yes, customer must have all of the following, quality control representative, quality assurance manual and supporting written procedures.
定期的验证试验应使用书面程序显示未检测到的阻止SIS按照安全要求规格操作的故障。
Periodic proof tests shall be conducted using a written procedure to reveal undetected faults that prevent the SIS from operating in accordance with the safety requirements specification.
这带来的结果是需完成大量的书面程序，受训者在工作现场和现场外被教授了大量重复的内容。
The result has been much paperwork, and much repetition of what trainees get taught inside and outside the workplace.
此项质量手册应包括或提及质量系统的各项书面程序，以及略述本质量系统所使用之文件架构。
The quality manual shall include or make reference to the quality system procedures and outline the structure of the documentation used in the quality system.
此项质量手册应包括或提及质量系统的各项书面程序，以及略述本质量系统所使用之文件架构。
The quality manual shall include or make reference to the quality system procedures and outline the structure of the documentation used in the quality system.
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