GMP

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GMP 是英文 Good Manufacturing Practice 的缩写，中文通常称为 “良好生产规范” 或 “药品生产质量管理规范



GMP is the abbreviation for Good Manufacturing Practice in English, commonly referred to as "Good Manufacturing Practice" or "Good Manufacturing Practice" in Chinese

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• GMP 是一套适用于制药、食品等行业的强制性标准，要求企业从人员、厂房、设备、物料、生产过程、质量控制等方面按国家有关法规达到卫生质量要求，形成一套可操作的作业规范，帮助企业及时发现生产过程中存在的问题并加以改善，确保产品质量和安全。
• 最早是由美国于 20 世纪 60 年代提出，旨在确保药品的安全性、有效性和均一性。后来，世界各国纷纷借鉴并制定了自己的 GMP 标准，使其成为国际上通用的质量管理体系
  

GMP is a set of mandatory standards applicable to industries such as pharmaceuticals and food, requiring companies to meet hygiene and quality requirements in terms of personnel, factory buildings, equipment, materials, production processes, quality control, and other aspects in accordance with relevant national regulations. It forms a set of operable operating standards to help companies timely identify and improve problems in the production process, ensuring product quality and safety.
It was first proposed by the United States in the 1960s to ensure the safety, efficacy, and uniformity of drugs. Later, countries around the world drew on and developed their own GMP standards, making them a widely used quality management system internationally

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人员要求

• 企业必须配备具有相应专业知识和技能的管理人员和技术人员，如质量管理人员应具备药学或相关专业知识，熟悉药品质量管理法规和标准。
• 所有员工都要接受定期的培训，包括岗位技能培训、GMP 知识培训等，以确保其能够熟练掌握并遵守相关规范
  

Personnel requirements
Enterprises must equip management and technical personnel with corresponding professional knowledge and skills, such as quality management personnel who should have pharmaceutical or related professional knowledge, be familiar with drug quality management regulations and standards.
All employees must receive regular training, including job skills training, GMP knowledge training, etc., to ensure that they can proficiently master and comply with relevant regulations

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• 厂房与设施
  
  • 厂房的选址、设计、布局应符合生产要求，避免交叉污染和混淆，例如不同生产区域要根据产品特性和生产工艺进行合理划分，设置必要的隔离设施。
  • 要配备相应的设施设备，如空调净化系统、给排水系统等，以保证生产环境的温度、湿度、洁净度等符合规定标准。
    
• Factory buildings and facilities
• The site selection, design, and layout of the factory should meet production requirements, avoid cross contamination and confusion. For example, different production areas should be reasonably divided according to product characteristics and production processes, and necessary isolation facilities should be set up.
• Corresponding facilities and equipment should be equipped, such as air conditioning purification systems, water supply and drainage systems, etc., to ensure that the temperature, humidity, cleanliness, etc. of the production environment meet the prescribed standards.
  

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设备管理

• 设备的选型、安装应符合生产要求，易于清洁、维护和操作，如制药设备要选用符合药品生产卫生要求的材质，避免设备对药品质量产生影响。
• 建立完善的设备维护保养和校准制度，定期对设备进行检查、维修和校准，确保设备的正常运行和性能稳定
  

device management
The selection and installation of equipment should meet production requirements, be easy to clean, maintain, and operate. For example, pharmaceutical equipment should use materials that meet the hygiene requirements of drug production to avoid affecting the quality of drugs.
Establish a comprehensive system for equipment maintenance and calibration, regularly inspect, repair, and calibrate equipment to ensure its normal operation and stable performance

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物料管理

• 物料的采购应确保供应商的资质和物料的质量，对原辅料、包装材料等进行严格的质量检验和验收，如原辅料要符合相应的质量标准，包装材料要能保证药品在储存和运输过程中的质量。
• 物料的储存和发放要遵循先进先出、近效期先出的原则，有专门的仓储区域，对温度、湿度等环境条件进行控制，确保物料的质量稳定
  

material management
The procurement of materials should ensure the qualifications of suppliers and the quality of materials. Strict quality inspection and acceptance should be carried out on raw materials, packaging materials, etc. Raw materials should meet corresponding quality standards, and packaging materials should ensure the quality of drugs during storage and transportation.
The storage and distribution of materials should follow the principles of first in, first out and near expiry, with dedicated storage areas to control environmental conditions such as temperature and humidity, ensuring stable material quality

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• 生产管理
  
  • 制定详细的生产工艺规程和标准操作规程，明确生产过程中的各个环节和参数，操作人员要严格按照规程进行生产操作，保证产品质量的一致性。
  • 加强生产过程的监控和记录，对生产过程中的关键控制点进行实时监测，如在药品生产中，对灭菌环节的温度、时间等参数进行严格监控，并做好详细记录。
    
• Production management
• Develop detailed production process regulations and standard operating procedures, clarify each link and parameter in the production process, and ensure that operators strictly follow the regulations for production operations to ensure consistency in product quality.
• Strengthen the monitoring and recording of the production process, and conduct real-time monitoring of key control points in the production process. For example, in drug production, strictly monitor parameters such as temperature and time in the sterilization process, and make detailed records.
  

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质量管理

• 建立完善的质量管理体系，包括质量标准、质量检验、质量保证和质量改进等方面，如制定原辅料、中间体、成品的质量标准，对产品进行全项检验。
• 设立独立的质量管理部门，负责对产品质量进行全程监控和管理，有权对不符合质量要求的产品进行处理
  

Quality Assurance
Establish a sound quality management system, including quality standards, quality inspection, quality assurance, and quality improvement, such as developing quality standards for raw materials, intermediates, and finished products, and conducting comprehensive inspections of products.
Establish an independent quality management department responsible for monitoring and managing product quality throughout the entire process, with the authority to handle products that do not meet quality requirements

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• 保障产品质量：通过对生产全过程的严格控制，确保产品符合质量标准，减少产品质量问题和安全隐患，保护消费者的健康和权益。
• 提升企业管理水平：促使企业建立科学、规范的质量管理体系，提高企业的管理效率和运营水平，增强企业的市场竞争力。
• 促进产业发展：有助于整个行业的规范化和标准化，推动制药、食品等产业的健康发展，提升行业的整体形象和国际声誉。
• 满足法规要求：企业只有符合 GMP 要求，才能获得生产许可，产品才能在市场上合法销售，有助于监管部门对企业进行有效的监督和管理
  

Ensuring product quality: By strictly controlling the entire production process, we ensure that products meet quality standards, reduce product quality issues and safety hazards, and protect the health and rights of consumers.
Improving the management level of enterprises: promoting the establishment of a scientific and standardized quality management system, improving the management efficiency and operational level of enterprises, and enhancing their market competitiveness.
Promoting industrial development: It contributes to the standardization and normalization of the entire industry, promotes the healthy development of industries such as pharmaceuticals and food, and enhances the overall image and international reputation of the industry.
Compliance with regulatory requirements: Enterprises can only obtain production licenses and legally sell products in the market if they meet GMP requirements, which helps regulatory authorities to effectively supervise and manage enterprises

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学习了，双语的质量标准！