Search results for " compliance"
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 …
Article
Design and Qualification of Single-Use Systems
The author provides a review of the concepts of design and qualification that apply to single-use systems.
By Jerold M. Martin
Single-use technologies (SUT) have made significant inroads in …
Article
Reporting Quality Metrics to FDA
What do you recommend?
A: As with all regulations or guidance documents, there can be various approaches to achieving compliance. Quality metrics need to be specific to each business and circumsta…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
• Testing design should be suitable for the process and, at a minimum, in compliance with the current regulatory requirements.
• Testing should be conducted at the most meaningful process …
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
This approach would help support quality compliance of the facility. It is also important to pay attention to release tests of media from a single supplier, because it is easier to accidently substitu…
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
With the plethora of regulatory guidelines and associated compliance requirements to adhere to when building a facility, it must be clear whether the product is for research and development purposes (…
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
To date, compliance levels and the impact of reporting guidelines to improve study reproducibility have been disappointing (28), but multidisciplinary efforts continue to promote transparency, opennes…
Article
Best Practices in Qualification of Single-Use Systems
The end user needs to perform quality audits and technical due diligence visits to ensure compliance as well as a deep understanding of all these aspects, and then carry out science-based risk assessm…
Article
Taking a “Development-by-Design” Approach to Cell Therapies
Jun 15, 2015
By Agnes Shanley
BioPharm International eBooks
Volume 28, Issue 13
Whether outsourcing or developing cell therapies in-house, success demands a focus on quality, c…