Search results for " risk-based" in Articles / App Notes
Article
Good Manufacturing Practices: Challenges with Compliance
This [expedited timeline] drives the need for early and continuous engagement with the agency to ensure transparency and shared understanding of risk-based, scientifically sound approaches being lever…
Article
The Need for Advanced Process Modeling for New Therapeutic Biologics
FDA has noted in the past that many innovator pharma companies have, for the most part, embraced the science and risk-based approaches in QbD and that other companies, such as generic and biotech comp…
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Addressing the Complex Nature of Downstream Processing with QbD
The effort can be reduced by a risk-based approach where the studies are focused on the most important (or less well-known) factors.” To address this, the use of mechanistic modeling, and other emergi…
Article
An Analytical Approach to Biosimilar Drug Development
Using this approach is considered reasonably risk-based, as safety and immunogenicity have presumably already been assessed for the innovator.
Evolutions in signal amplification and dissociat…
Article
Supply Chain Challenges for Single-Use Systems
Managing change is challenging in a rapidly growing market with continuous evolving guidance that requires a smart risk-based approach. One size does not fit all. We have extensive knowledge of our cu…
Article
Understanding Validation and Technical Transfer, Part 3
In terms of quality by design (QbD), specifications account for only one element of the overall product control strategy, which should employ a science and risk-based approach to define quality attrib…
Article
Bioburden Control in the Biopharmaceutical Industry
Field, “Bioburden Control at the Sterile Filtration Step: A Risk-Based Approach,” presentation to European Biopharmaceutical Enterprises (May 2013).
10. Critical Process Filtration Inc., “Partic…
Article
Avoiding Investigational Failures and Discrepancies
In this risk-based issue review phase an incident can be corrected or mitigated and closed, or a CAPA can be initiated, depending on what was discovered during the review. Each issue must be assessed …
Article
Best Practices for Data Integrity
You must validate the computerized system following a thorough, risk-based approach. The validation efforts for Part 11-compliant systems varies depending on whether or not the people using the system…
Article
Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
…roduction in Microbial Hosts
Single-use Technologies in Downstream Process Intensification
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and …