Should the quality unit review and approve a procedure that, for example, tells a mechanic how to put oil into a pump? Another example, should they approve housekeeping procedures? 问:Q7A指出,质量部门应当审查并批准所有与质量相关的文件。专家组对于这条规定的适用范围是如何界定的?很容易明白为什么...
需要金币:*** 金币(10金币=人民币1元) WHO医用气体GMP指南(2021草案).pdf 关闭预览 想预览更多内容,点击免费在线预览全文 免费在线预览全文 Working document QAS/21.875 February 2021 DRAFT WORKING DOCUMENT FOR COMMENTS: Good manufacturing practices for medical gases Please send your comments to Dr Sabine...
PROCEDURE 1.Determination of Finished Good Shelf Life 1.1.The finished good shelf life is determined per SOP-110 Stability Testing. 1.2.The finished good shelf life is identified per SOP-130 Finished Good Specification. Each approved finished good specification shall be signed and scanned into a P...
10. Change and Configuration Management 变更和配置管理 Any changes to a computerised system including system configurations should only be made in a controlled manner in accordance with a defined procedure. 计算机系统的任何变更(包括系统配置的更换)应当有控制地按照规定的程序 进行。 11. Periodic ...
PROCEDURE 1.Determine size and style of component 1.1Once the need for a new or revised printed component is identified, Package Development will determine the appropriate size and style of the label, carton, packer, or other component. 1.2Assign a part number. Part numbers are obtained fromQA...
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Any changes should be carried out according to a written procedure, which should address any implications for product quality such as stability and bio equivalence. 7. Rationales for changes should be recorded and the consequences of a change on product quality and on any on-going clinical trials...
But the quality unit does not necessarily need to review the detailed procedure on how that preventative maintenance is done. The same thing for housekeeping, where the quality unit should review the procedure defining how often, whos going to do it, that sort of thing, but the details of ...
there is a procedure for Self-Inspection and/or quality audit which regularly appraises the effectiveness and applicability of the Quality Assurance system. 三、药品生产质量管理规范(GMP)Good Manufacturing Practice for Medicinal Products GMP 是质量保证的一部分,它确保药品始终按照适合于其使用目的的质量...
MHRA 的GMP 数据完整性定义和行业指南/2015年3月 Introduction:背景介绍 Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. This document provides MHRA guidance on GMP data integrity expectations for the pharmaceutical industry. This ...