|
所在平台: Udemy |
课程主页: https://www.udemy.com/course/effci-gmp-guideline-for-cosmetic-ingredients-manufacturing/
课程评论：没有评论
课程名称：EFfCI化妆品成分制造的良好生产规范（GMP）指南 课程概述： 化妆品产品的安全性依赖于化妆品成分的质量和安全性，因此，良好生产规范（GMP）对全球制造商至关重要。本课程由注册审计师和培训师准备和呈现，旨在帮助化妆品成分及化妆品制造商了解EFfCI的标准。此标准由个人护理产品委员会和欧洲联合会制定，主要涉及化妆品相关主题。若您已经接受了ISO 9001:2015的质量管理体系标准培训，将能更好地理解GMP指南。EFfCI与ISO 9001质量标准对齐，认证机构可对其进行共同审核，EFfCI认证要求供应商持有有效的ISO 9001证书，但参加ISO 9001:2015培训并不是本课程的先决条件。本课程仅提供与EFfCI指南相关的信息，更多详细信息请访问EFfCI官网。 GMP是一系列旨在减少不良质量和/或受污染的化妆品成分对最终用户（消费者）造成风险的规则。虽然GMP通常只被认为适用于生产领域，其原则实际上涵盖了多个方面。 GMP原则包括： - 产品不得故意或非故意地伤害最终用户。 - 产品规格不仅仅是产品质量的完整定义。 - 产品纯度、污染控制、微生物学、尘埃和杂物、异物、水质、取样活动等。 - 控制生产环境中其它物质的交叉污染，包括其他产品、原材料和工艺助剂（如润滑剂等）。 - 个人卫生、设备和工作场所清洁度、设备维护。 - 批次间产品质量的一致性，使用相同的产品工厂/制造过程、原材料、批次分析、配方、再处理和再加工控制、对重复使用成分（如溶剂、重结晶）的控制。 - 变更管理系统，在实施变更前考虑对产品质量的影响，并确认变更结果未改变产品及其性能。 - 记录活动的可追溯性（如设备使用、执行职能的人员、标签等）、原材料到成品的可追溯性和销售产品到客户的可追溯性。 - 具备从市场召回批次的能力、科学基础的产品质量决策、使用风险评估（对产品质量和最终用户安全）以及适合的证据确保化妆品成分在供应链中稳定，直至被化妆品制造商使用。 - 处理超标程序、对意外结果的科学评估、与生产和商业压力分开的质量单位、产品释放、关键制造和分析设备的校准。 - EFfCI化妆品指南检查表和标准作为本课程的资源材料。 本课程的学习将有助于理解化妆品成分生产中GMP的重要性及其实际应用。
Cosmetic products safety is depend on cosmetic ingredients quality and safety, for that reason GMP is essential for manufacturer in all over world. This course is prepared and presented by registered auditor and trainer.This course is designed for manufacturer of cosmetic ingredients and cosmetic product manufacturer. Personal Care products council and European federation are prepared this standard. European federation deals with these topics on cosmetics.If you got quality management system standard ISO 9001:2015 training, yo will understand better GMP guideline. EFfCI aligned with ISO 9001 quality standard and can be audited together by certification bodies. EFfCI Certification requires the supplier to hold a valid ISO 9001 Certificate. But getting ISO 9001:2015 training is not prerequisite for this course.This course is only information related EFfCI guideline and for further information see EFfCI website.GMP is a set of rules designed to minimise the risks posed to end users (consumers) from poor quality and or contaminated cosmetic ingredients.Always that is known that gmp is the set of the rules only production area. However principles include many subjects.GMP PrinciplesThe following principles should be applied in relation to the risks posed to the user of the cosmetic; means the consumer. You are consumer and your family, friends are consumer.The product shall not intentionally or unintentionally harm the end user,The product specification is not a complete definition of product quality,Product purity,Contamination control,Microbiology,Dust and dirt,Foreign objects,Water quality,Sampling activities, Etc.Cross contamination control from other substances in the manufacturing environment, including other products, raw materials and process aids (e.g. lubricants etc.),Personal Hygiene,Equipment and workplace cleanliness,Equipment maintenance,Consistency of product quality from batch to batch,Through use of the same,Product plant/manufacturing process,Raw materials,Analysis of batches,Recipe,Controls over reprocessing and reworking,Controls over reused ingredients (e.g. solvents, recrystallisations),Change Management System,Consideration of impact of change on product quality before implementation of the change,Verification that changes result in a product that is unaltered and has the same performance,Traceability of actions to planned arrangements,Records of these activities (equipment use, personnel performing functions, labelling etc.),Traceability of raw materials to finished productsNot optional,Traceability of sold products to customers,Not optional,Ability to recall a batch from the market,Scientific basis for making product quality decisions - Good science - a result is worth a thousand words,Use of risk assessments (to product quality and end user safety),Suitable evidence of cosmetic ingredient stability in the supply chain up until the point of use by the cosmetic manufacturer,Out of Specification Procedure,Scientific evaluation of unexpected results,Quality unit separate from production and commercial pressures,Product release,Calibration of critical manufacturing and analytical equipment,EFfCI Cosmetic guideline checklist and standard could be found as resource material inside the course.
