医药制造中的良好质量实践（GQP）：一本手册

English | 509 pages | Bentham Science Publishers (January 19, 2018) | 1681081156 | PDF | 5.96 Mb

Pharmaceutical manufacturing can be viewed as a supply chain which spans from the production and purchase of the starting and packaging materials through the manufacture of dosage forms until the safe reception of the finished product by the patient. The entire chain comprises of several processes: auditing, materials purchase (procurement), production, storage, distribution, quality control, and quality assurance. The quality standard for pharmaceutical production is ‘current good manufacturing practice (CGMP)’, which is applied within the frame of a pharmaceutical quality system (PQS). This implementation, however, requires a scientific approach and has to take into account several elements such as risk assessment, life cycle, patient protection, among other factors. Hence, pharmaceutical manufacturing is a complex subject in terms of regulation, given the technical and managerial requirements. This comprehensive handbook describes CGMP for new professionals who want to understand and apply the elements which build up pharmaceutical quality assurance. The book gives details about basic quality control requirements (such as risk management, quality hazards and management systems, documentation, clean environments, personnel training) and gives guidelines on regulatory aspects. This is an ideal handbook for undergraduates studying pharmaceutical or industrial manufacturing and supply chains as well for entrepreneurs and quality control professionals seeking to learn about CGMP standards and implementing quality assurance systems in the pharmaceutical sector.

医药制造可以看作是一个从原材料的采购与生产、包装材料的购买，到制剂的制造直至成品安全接收患者的供应链。整个链路包括多个过程：审计、物料采购（采购）、生产、储存、分销、质量控制和质量管理。药品生产的质量标准是“现行良好生产规范”(CGMP)，它在制药质量系统(PQS)的框架内应用。然而，这种实施需要科学的方法，并且必须考虑到风险评估、生命周期、患者保护等多个因素。因此，在法规方面，医药制造是一个复杂的问题，因为它涉及到技术与管理要求。这本全面的手册描述了新专业人员理解并应用构成药品质量管理要素的基本良好生产规范(GMP)。此书详细介绍了基本的质量控制要求（如风险管理、质量危害和管理系统、文件记录、清洁环境、人员培训）以及提供了监管方面指南。这是为学习GMP标准及在制药领域实施质量保证体系的理想手册，适用于就读于医药或工业制造与供应链专业的本科生，以及寻求了解GMP标准并实现质量保证系统的创业者和质量管理专业人士。

---

Download from free file storage

 Download from rapidgator.net  Download from nitroflare.com

---

我要反馈

---

本站不对文件进行储存，仅提供文件链接，请自行下载，本站不对文件内容负责，请自行判断文件是否安全，如发现文件有侵权行为，请联系管理员删除。