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正文内容
人——包括组织机构、人员、培训
People - including organizational structure, personnel, training
机——包含设施、设备的技术要求、安全操作、维护保养、状态标识、设备记录。
Machine - includes technical requirements for facilities and equipment, safe operation, maintenance, status identification, and equipment records.
料——包含物料管理基础、物料管理与生产。
Material - includes the foundation of material management, material management, and production.
法——包括公司的各项规章制度、程序文件、文件使用等，涵盖企业管理的各个方面。
Law - including various rules and regulations, procedural documents, document usage, etc. of the company, covering various aspects of enterprise management.
环——环是指药品生产所处的整个环境，它包括外部环境卫生、生产工艺卫生及个人卫生等。
Ring refers to the entire environment in which drugs are produced, including external environmental hygiene, production process hygiene, and personal hygiene.
10、质量负责人的资质要求？
10. What are the qualification requirements for the quality manager?
质量管理负责人应当至少具有药学或相关专业本科学历（或中级专业技术职称或执业药师资格），具有至少五年从事药品生产和质量管理的实践经验，其中至少一年的药品质量管理经验，接受过与所生产产品相关的专业知识培训。
The person in charge of quality management should have at least a bachelor's degree in pharmacy or related fields (or an intermediate professional technical title or licensed pharmacist qualification), and have at least five years of practical experience in drug production and quality management, including at least one year of drug quality management experience, and have received professional knowledge training related to the products produced.
11、生产负责人的资质要求？
11. What are the qualification requirements for the production manager?
生产管理负责人应当至少具有药学或相关专业本科学历（或中级专业技术职称或执业药师资格），具有至少三年从事药品生产和质量管理的实践经验，其中至少有一年的药品生产管理经验，接受过与所生产产品相关的专业知识培训。
The person in charge of production management should have at least a bachelor's degree in pharmacy or related fields (or an intermediate professional technical title or licensed pharmacist qualification), and have at least three years of practical experience in drug production and quality management, including at least one year of drug production management experience, and have received professional knowledge training related to the products produced.
12、质量受权人的资质要求？
12. What are the qualification requirements for quality authorized persons?
质量受权人应当至少具有药学或相关专业本科学历（或中级专业技术职称或执业药师资格），具有至少五年从事药品生产和质量管理的实践经验，从事过药品生产过程控制和质量检验工作。质量受权人应当具有必要的专业理论知识，并经过与产品放行有关的培训，方能独立履行其职责。
The quality authorized person should have at least a bachelor's degree in pharmacy or related majors (or intermediate professional and technical titles or licensed pharmacist qualifications), at least five years of practical experience in drug production and quality management, and have been engaged in drug production process control and quality inspection work. The quality authorized person should have necessary professional theoretical knowledge and undergo training related to product release in order to independently fulfill their responsibilities.
13、药物警戒负责人的资质要求？
13. What are the qualification requirements for the person in charge of pharmacovigilance?
具有医学、药学、流行病学、生物医学工程或者相关专业背景，本科及以上学历或者中级以上专业技术职称，三年以上从事药物警戒相关工作经历，熟悉我国药物警戒相关法律法规和技术指导原则，具备管理药物警戒工作的知识和技能。
With medical, pharmaceutical, epidemiological, biomedical engineering or related professional background, bachelor's degree or above, or intermediate or above professional technical title, more than three years of experience in pharmacovigilance related work, familiar with China's laws and regulations related to pharmacovigilance and technical guidelines, and have knowledge and skills in managing pharmacovigilance work.
药物警戒负责人应当在国家药品不良反应监测系统中登记。
The person in charge of drug vigilance shall register in the national adverse drug reaction monitoring system.
14、物料发放和使用要点是什么？
14. What are the key points for material distribution and use?
1）依据生产、包装指令发放
1) Distribute according to production and packaging instructions
2）发放领用复核，防止差错
2) Distribution and requisition review to prevent errors
3）及时登记、账物相符，便于追溯
3) Timely registration and matching of accounts and materials for easy traceability
4）物料拆零环境与生产环境相适应，防止污染
4) Adapt the material disassembly environment to the production environment to prevent pollution