ISPE发布工艺验证新指南

3月，Good Practice Guide: Process Validation。该指南英文全文ISPE官网对该指南的介绍，翻译如下，供参考和了解。

The shift in process validation from a one-time event to the product lifecycle approach expected by most global markets has led to significant changes in validation practices. The science and risk-based approach combines product development knowledge with a structured process performance and product quality monitoring system to provide for validation throughout the product lifecycle.

工艺验证从一次性事件转变为大多数全球市场所期望的产品生命周期方法，导致了验证实践的重大变化。基于科学和风险的方法将产品开发知识与结构化的工艺性能和产品质量监控系统相结合，从而将验证贯穿整个产品生命周期。

In today’s pharmaceutical industry, process validation relies on information and knowledge from product development activities to ensure patient requirements are translated into product attributes. A key to success is establishing a comprehensive science-based process design that focuses on understanding sources of variability. Translating the sources of variability into a well-designed control strategy that reliably ensures a product’s attributes are attained may help achieve robust product realization.
在当今的制药行业，工艺验证依赖于产品开发活动中的信息和知识，以确保将患者需求转化为产品属性。成功的关键是建立一个全面的基于科学的工艺设计，重点是理解可变性的来源。将可变性源转换为设计良好的控制策略，从而可靠地确保获得产品的属性，这可能有助于实现稳定的产品。

Covering a wide variety of manufacturing types, the ISPE Good Practice Guide: Practical Implementation of the Lifecycle Approach to Process Validation is a reference of technical and scientific detail to help organizations conduct process validation from scientifically sound development to robust reliable processes. It is intended to assist companies in understanding the application of global regulatory validation requirements by providing step by step implementation approaches to PV and leveraging process understanding to promote best practices. The use of statistical rationales within the different stages of the process validation lifecycle is explained. Case studies demonstrating the benefits of some of the Guide’s practices in action are also included.

:工艺验证的生命周期方法，涵盖了多种制造类型，参考了技术和科学细节，以帮助组织进行工艺验证，从科学可靠的开发到稳定可靠的工艺。它旨在通过为 

Process Validation in Context of Small Molecule DS and DP Continuous Mfg Processes

官网原文链接：https://ispe.org/publications/guidance-documents/good-practice-guide-process-validation

===来自网络转载