如果说你没有到过工厂 (食品工厂业，药物工厂业) 里面工作，或许你根本没有意识到良好生产规范 (GMP = Good Manufacturing Practice) 这个词汇。
或许可能你会留意到的是从食品包装上，例如一些食品业会在他们所生产的加工食品的包装上印刷 GMP logo, 极少。
那，到底什么是 良好生产规范 (GMP = Good Manufacturing Practice) ?
你，又知道多少呢 ？
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良好生产规范 (GMP = Good Manufacturing Practice) 是一种确保产品自始至终按照产品质量标准制造和控制的体系。 它旨在最大限度地减少任何的生产制造所涉及到的风险，而这些风险无法通过测试最终产品来消除。
良好生产规范 (GMP) 认证主要面向食品，药品和医疗设备产品的生产企业。
GMP 明确了生产商必须符合的最低要求，以保证其商品自始至终具备高品质。因此 GMP 认证对于化妆产品，药物，膳食补充剂和医疗器械等产品销售的机构是非常需要的。许多国家已立法要求生产遵循 GMP 程序流程并制定符合其立法的 GMP 公司指南。
GMP 通常通过有效使用质量管理体系 (QMS) 来确保。它涵盖了生产的各个方面，从起始材料，场所和设备到员工培训和个人卫生。详细的书面程序流程对于可能会影响成品质量的每一个全过程都是必不可少的。必须要有系统的文档来证明在制造的每一步，每次制造产品的时候自始至终遵循正确程序流程，以保证制成品对人类消费或使用是安全的。
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GMP 良好生产规范 (Good Manufacturing Practice), 也称 cGMP, c即 current (现行), 译为现场良好生产规范。
GMP 针对不同行业的企业，从工厂选址，厂房，设备。设施，人员，原辅料，生产/操作过程，检验，贮存，运输，投诉，召回，产品信息，培训等方面进行规定，帮助企业形成良好的生产和操作规范，以确保产品的质量，安全和针对消费的适用性。
GMP 认证的益处
- 证明企业在产品质量，安全保证方面的管理能力
- 使员工养成良好的生产/操作习惯
- 降低企业在产品和安全上的风险
- 及时发现生产和管理的问题，降低成本
- 更好理解和满足相关法律，法规的要求
- 提升国际公信力和公众形象
- 增加客户对企业的长期信心
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一次偶然的机会下，Nexus Consultant 提供的 webinar, 题目是关于 良好生产规范 (GMP = Good Manufacturing Practice)。
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GMP stands for Good Manufacturing Practices, a system that ensures that manufactured products - such as food, cosmetics, and pharmaceutical goods - are consistently produced and controlled according to set quality standards.
Implementing GMP can help cut losses and waste, and avoid recalls, fines, and jail time. Overall, it protects both the company and the consumer from negative food safety events.
GMPs examine and cover every aspect of the manufacturing process to guard against any risks that can be catastrophic for products, such as cross-contamination, adulteration, and mislabeling.
Some areas that can influence the safety and quality of products that GMP guidelines and regulations address are the following:
1. Quality Management
2. Sanitation and Hygiene
3. Building and Facilities
4. Equipment
5. Raw Materials
6. Personnel
7. Validation and Qualification
8. Complaints
9. Documentation and Record Keeping
10. Inspections & Quality Audits
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What are the 5 Main Components of Good Manufacturing Practice?
1. People - All employees are expected to strictly adhere to manufacturing processes and regulations. A current GMP training must be undertaken by all employees to fully understand their roles and responsibilities. Assessing their performance helps boost their productivity, efficiency and competency
2. Products - All products must undergo constant testing, comparison, and quality assurance before distributing to consumers. Manufacturers should ensure that primary materials including raw products and other components have clear specifications at every phase of production. The standard method must be observed for packing, testing, and allocating sample products
3. Processes - Processes should be properly documented, clear, consistent, and distributed to all employees. Regular evaluation should be conducted to ensure all employees are complying with the current processes and are meeting the required standards of the organization
4. Procedures - A procedure is a set of guidelines for undertaking a critical process or part of a process to achieve a consistent result. It must be laid out to all employees and followed consistently. Any deviation from the standard procedure should be reported immediately and investigated
5. Premises - Premises should promote cleanliness at all times to avoid cross-contamination, accidents or even fatalities. All equipment should be places or stored properly and calibrated regularly to ensure they are fit for the purpose of producing consistent results to prevent the risk of equipment failure
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What are the 10 Principles of GMP ?
1. Created Standard Operating Procedures (SOP)
2. Enforce/Implement SOPs and Work Instructions
3. Document Procedures and Processes
4. Validate the Effectiveness of SOPs
5. Design and use working systems
6. Maintain System, Facilities and Equipment
7. Develop Job Competence of workers
8. Prevent Contamination through Cleanliness
9. Prioritize Quality and Integrate into Workflow
10. Conduct GMP audits regularly
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