Both the management and the persons responsible for quality assurance should be actively involved in the validation activities as well as in the authorization of protocols and reports. Regarding the topic risk management which should be used, it is referred to a specific WHO guideline. Where ...
37、ns responsible for quality assurance should be actively involved in the process and authorization of protocols and reports. 高级管理层应该确保充分的资源来及时地执行验证。管理层和质量保证负责人应该积极参与方案和报告的批准活动中。5.7 Personnel with appropriate qualification and experience should be resp...
communicationandreviewofriskstothequalityofthe pharmaceuticalproductthroughouttheproduct’slifecycle. 质量风险管理(QRM) 一个系统流程,在整个产品生命周期中评估、控制、沟通和回顾药品 质量风险。 receivingunit(RU). Theinvolveddisciplinesatanorganizationwhereadesignated product,processormethodisexpectedtobetransferred. ...
oresponsibleforqualityassuranceshouldbeactivelyinvolvedintheprocess p eandauthorizationofprotocolsandreports. R l a c i n5.6Personnelwithappropriateeducationandexperienceshouldberesponsible h c eforqualificationandvalidation. T O H W5.7Thereshouldbeaspecificprogrammeorscheduletosupportplanningand ...
The involved disciplines at an organization from where a designated product, process or method is expected to be transferred. 转移方(SU) 一个组织中的相关机构,准备转移指定产品、工艺或方法。 standard operating procedure (SOP). An authori...
48、t system including organizational structure and documentation infrastructure, sufcient personnel and nancial resources to perform validation tasks in a timely manner. Management and persons responsible for quality assurance should be involved. 为了及时执行验证工作,应当建立一个适当且能满足需要的系统,包括...
5.6 Senior management should ensure that there are sufficient resources to perform validation in a timely manner. Management and persons responsible for quality assurance should be actively involved in the process and authorization of protocols and reports. 高级管理层应该确保充分的资源来及时地执行验证。
colleagues who are traveling with me like our famous interpreter, and like Bill Weinstein, who's the head of our economic section, who have been involved in U.S.-China relations for 30 years as well. eng.embassyusa.cn 我有一些同行在陪同我,像我们有名的翻译,还有像别比尔·外因斯坦, 我们...
《WHO制药生产技术转移指南( WHO guidelines on the transfer of technologyin pharmaceutical manufacturing)》,该指南解读及全文翻译如下: 1、要求转移方和接收方都应该有一个适当设计、明确定义和书面的质量体系。质量体系应具备足够的资源,充分实施和维护。 2、要求质量体系应包含GxP,不单单是GMP。 3、应保留技术...
2.5. Because each transfer project is unique, the provision of a comprehensive set of guidelines specific to a product or process is beyond the scope of this document. 由于每个转移项目都是唯一的,因此针对产品或工艺提供的全面指导超出了本文档的范围。