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...
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...
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...
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...
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...
ISPE announced the release of their latest guide, ISPE Good Practice Guide: Practical Implementation of the Lifecycle Approach to Process Validation . This guide provides professional insights for fundamental principles, process lifecycle approaches,...
Continued Process Verification (CPV), the 3rd Stage of the FDA process validation guidelines, represents the Ship of Theseus in bioprocessing:
The bioprocess is validated and on the market, but it inevitably is subject to changes in supplies, raw...
Process characterization is an essential step in the commercialization of a new (biological-) drug. For drug product commercialization, manufacturers must validate the drug’s manufacturing process. This ensures, that the manufacturing process delivers...
