CGMP--Current-Good-Manufacturing-Practice(中英文对照版).doc

§ 211.28 Personnel responsibilities. Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination. Personnel shall practice good sanitation and health habits. Only personnel authorized by supervisory personnel shall enter those areas of the buildings and facilities designated as limited-access areas. Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products. § 211.34 Consultants. Consultants advising on the manufacture, processing, packing, or holding of drug products shall have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Records shall be maintained stating the name, address, and qualifications of any consultants and the type of service they provide. 211．28人员职责 从事药品生产、加工、包装或仓贮的人员，应穿着适合于其履行职责的清洁衣服，按需要，按头部、脸部、手部、臂部加外罩，防止药品受污染。 人员保持良好的个人卫生和健康。 未经监督人员允许，其他人不能进入限制入内的建筑物和设施。 211.34参谋 Protective apparel 洁净服，保护服 sanitation 卫生，卫生设施， jeopardize 危害 Subpart C-Buildings and Facilities § 211.42 Design and construction features. Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction and location to facilitate cleaning, maintenance, and proper op