Process Validation

Technical
Continued process verification (CPV) as defined in the US FDA process validation guidelineUS Food and Drug Administration. “Guidance for Industry. Process Validation: General Principles and Practices.” 2011. https://www.fda.gov/media/71021/download helps bring quality management and compliance in...
Video
Lifecycle Process Validation guidance has been published by FDA in 2011 and by PIC/S and EMA in 2015. This guidance reflects ICH guidance on enhanced development and product quality monitoring practices using approaches...
Online Live
Online Live Overview Lifecycle Process Validation (PV) remains one of the most important and commonly misunderstood topics in the pharmaceutical industry. How many lots should I make? Are we taking enough samples? Do we...
Guidance Docs
In August 2017, ISPE published the Discussion Paper “Overview of Packaging Validation for Drug Products,” which explores the different ways to...
iSpeak Blog
Design and construction of facilities and equipment using modern day information technology is common in today’s project execution. Comprehensive 3D modelling, component databases, scheduling and planning are all common place, almost to the point that...
iSpeak Blog
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from July 2019. See trending ideas for regulatory compliance, biopharmaceutical innovation, and more for what the pharmaceutical industry was reading last month. Integrated...
Video
ISPE training instructor, Maurice Parlane, B Tech MIT, New Wayz Consulting Ltd., CBE Pty Ltd., shares the top three takeaways you will gain by attending ISPE process validation training. Register Now For even more on...
Video
Guide contributor (co-lead) Robert Beall, PMP, ProPharma Group, shares why process validation is an essential part of the pharma industry and how you’ll benefit from the ISPE Good Practice Guide: Practical Implementation...
iSpeak Blog
We are in a period of unprecedented change – some would even say disruption in the types of medicines and technologies adopted. This comes in an environment with ever increasing demands to improve time to market and manage resources. Process validation...