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药物生产质量管理规范 – 产品和证明。由西门子公司“制药”领域、GMP Group 的主管 Alexander Gierse 博士进行介绍 附加指南为计算机化系统的实施、评估和分类提供支持,并明确符合计算机化系统验证、审核追踪、用户管理、归档尤其数据完整性标准处理电子记录和签名。
Supplement Industry Seeks GMP Sneak Peek To Address Economic IssuesKatia Fowler
GMP includes a wide range of regulations, codes, and guidelines designed to oversee the production of pharmaceutical drugs. These practices are designed to ensure that products are consistently produced and controlled according to quality standards. In Japan, GMP compliance has evolved over time ...
That means production should take place in a controlled environment. Quality standards should guide the intended use of products. With the right cGMP software system, GMP compliance can be simple and continuous.Free Resources The State of Digital Maturity in Pharma and Medtech Manufacturing Download...
[4] World Health Organization. Technical Report Series No. 957,Annex 2:WHO good manufacturing practices for active pharma⁃ceutical ingredients[EB/ OL]. (2010 - 10 - 01) [2022 - 02 -28]. https:/ / www. who. int/ medicines/ areas/ quality _ safety/quality _ assurance/ GMPActivePha...
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MasterControl's corrective and preventive action (CAPA) software automates the management of the entire CAPA process. It connects quality events like nonconformances, deviations and customer complaints. The software improves product quality and safety to ensure adherence to GMP guidelines. ...
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