Search results for " compliance" in Articles / App Notes
Article
Understanding Validation and Technical Transfer, Part 3
Problems result when technology transfer does not embrace quality and compliance issues from the beginning, tasks and requirements are not fully defined and understood, and project management is inade…
Article
Applying GMPs in Stages of Development
Applying GMPs in Stages of Development
Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety, …
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Bryan Silvey, senior director for quality compliance at Kite Pharma, emphasized that personalized cell therapy production, utilizing a “one lot-one patient” manufacturing platform with a 15-d…
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Patenting Prospects for Cell-Based Therapies
Accordingly, patent exclusivity will be important to defray high development and regulatory compliance costs. The nature of such therapies, and recent patent law trends regarding natural products and …
Article
Avoiding Investigational Failures and Discrepancies
Tracking and documenting these actions during this analysis phase is crucial to maintaining regulatory compliance.
Be aware, however, of an investigational truism that many working in regulator…
Article
Ensuring Sterility in Small-Scale Production
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses how to ensure sterility when manufacturing small-scale parenteral batches.
By Susan J. Schniepp
Q. I am a …
Article
Drug Quality Key to Innovation and Access
The need for clear policies to ensure regulatory compliance and adherence to standards by contractors is reflected in a final guidance issued in November 2016 on establishing written quality agreement…
Article
Improving Process-Scale Chromatography
“An automation platform that consolidates process data also allows operators to spend time on more productive tasks, like process analysis, exception handling, and compliance support,” Ljungqvist says…
Article
Real Time Continuous Microbiological Monitoring
Denoya, “BioLaz: Real Time Microbial Monitoring in an Environmental Monitoring Program,” Presentation at the European Compliance Academy (Prague, 2014).
3. T. S. Blacker, Nature Communicat…
Article
Innovation vs. Capacity: How CMOs Compete
One is generic injectables, where product shortages owing to capacity exits and compliance problems at both domestic and offshore suppliers continue to plague the market. The other promising area, in …