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。
Improve data and process validation practices.
改善数据和工艺验证的做法。
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。
It is expressly mentioned that some process validation studies may beconducted on pilot-scale batches (corresponding to at least 10% or 100 000units whichever is the greater).
文字中提到，一些工艺验证研究可能是在中试批次上进行的（对应至少10%或10万剂单位，取大者）。
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。
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。
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。
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 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。
应用推荐