Existing risk-based approaches to computerized system compliance and validation as outlined in GAMP® 5International Society for Pharmaceutical Engineering. GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems. North Bethesda, MD: International Society for Pharmaceutical...
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...
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 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...
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...
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...
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...
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...
Continuous manufacturing (CM) technologies have recently been implemented in the pharmaceutical industry for process development, clinical trials, and commercial supply. This article is a high-level summary of a recently published ISPE Discussion Paper that details unique aspects of CM related to...
