Improve data and process validation practices.
改善数据和工艺验证的做法。
Process validation is a key in execution of GMP in pharmaceutical enterprise.
工艺验证是制药企业实施GMP规范的关键问题。
What is the type of the process validation, prospective, concurrent or retrospective?
您的工艺验证有哪些种类,前瞻性的、同步性的还是回顾性的?
Do you perform a process validation properly according to GMP Guidelines (revised in 2010)?
您按照药品GMP(2010年修订)的要求适当进行工艺验证了吗?
This book provides insights into the key aspects and current practices of process validation.
本书提供了关键方面的深刻见解和现行工艺验证规范。
Support related process validation, and complete microbial tests requested and report on time.
支持相关的工艺验证,及时完成相关的化学微生物检测活动,并出具报告。
Process validation continues to be a topic of much debate and confusion for biopharmaceutical manufacturers.
工艺验证一直是生物制药企业争论和困惑的话题。
Accurately scaling down to mimic manufacturing processes is essential in several aspects of process validation.
精确的规模缩小到模拟生产工艺在工艺验证中若干方面都是必不可少的。
To contribute the P1 process definition as well as the process validation (including DFMEA, FMEA Control Plan) according to the PVP.
根据PVP对P 1项目(包括失效模式分析以及控制计划)进行工艺编制及确认。
Quali?cation is often a part (the initial stage) of validation, but the individual quali?cation steps alone do not constitute process validation.
确认常常是验证的(起始阶段的)一个部分,但单独的确认步骤不是验证。
Process Validation Plan defines a set of tests that can be used to validate that an automated software development process fulfills control objectives.
过程验证计划(Process Validation Plan)定义了一系列用来确认自动化软件开发过程实现了控制对象的测试。
Process Validation: Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined requirements.
过程确认是指用客观的证据证明,通过某一生产过程而生产出的产品或得出的结果,始终满足该产品预设的要求。
Process characterization is a prerequisite for process validation. In Chapter 3, a description of how to carry out thorough and consistent process characterization is presented.
工艺特性鉴定是工艺验证的先决条件,在第三章中,出现了描述如何进行彻底的和连续的工艺特性鉴定。
Process validation is the documented evidence that a process is capable of consistently delivering quality product. The manufacturing process should be understood well before process validation.
工艺验证是确证生产工艺是否可连续生产出符合质量标准要求的产品的研究过程,进行工艺验证前,应通过详细的工艺研究对工艺有充分的理解。
In the following sections, we describe general considerations for process validation, the recommended stages of process validation, and specific activities for each stage in the product lifecycle.
在下述部分中,我们对工艺验证的总体考虑、建议的工艺验证和产品生命周期内每一阶段的特殊活动进行说明。
If you have process validation information indicating that you can reduce the amount of class 3 solvent to 0.5% or lower in the final product, you can discuss with FDA the possibility of using LOD.
如果你的工艺验证信息说明你可以将3类溶剂在成品中的数量降低至0.5%以下或更低,你可以与FDA讨论使用LOD的可能性。
This is part of the process of self-validation whereby we employ self-disclosures to seek support for our self-concept.
这是自我认可过程的一部分,我们通过自我表露来寻求对自我概念的支持。
If so, it skips the validation process by using the WHEN clause in the trigger body.
如果已经执行了验证,那么在触发器代码体中使用when子句跳过验证过程。
Now you have a background on the industry networks and technical validation process.
现在你已经有了行业网络和技术验证过程的知识背景。
Users will be treated with plain black desktop if their computers fail the validation process.
如果用户的电脑没有通过验证程序,就会遭遇一个纯黑的桌面。
Once you develop an application with IBM middleware or hardware, the next step is to validate the solution using the IBM technical validation process.
一旦你使用IBM中间件和硬件开发了一个应用程序,下一个步骤就是使用IBM技术验证过程验证这个解决方案。
The requirements validation process should confirm or reestablish end-user requirements and expectations.
需求验证过程将确认或重新建立终端用户需求和期望。
If any errors or warnings are reported during the validation process, it is suggested that you correct your model before proceeding to the transformation.
如果在验证过程中出现任何错误或警告,您就应当在进行转换前将您的模型修改正确。
The details of the validation process are now handled entirely by the invocation handler.
验证过程的细节现在完全由调用处理程序来处理。
The validation process can be performed by either manual method or automatic method.
这个确认过程可以由人工的方法来实现,也可以由自动操作来完成。
The validation process can be performed by either manual method or automatic method.
这个确认过程可以由人工的方法来实现,也可以由自动操作来完成。
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