Search results for " review"
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Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
Management reviews need to capture and aggregate risks across manufacturing campaigns to mitigate potential risks during changeover. In general, a biopharmaceutical manufacturer faces similar business…
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Global Expansion Shapes Drug Oversight
At the same time, FDA and the European Medicines Agency (EMA) annouced plans to expand their many collaborative programs, including renewal of a pilot program that allows for parallel review and consu…
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Implementing QbD in Sterile Manufacturing
…nufacturing?
Weikmann: Looking first at equipment design, we feel strongly that the design review process has to be mentioned as an essential tool. Design review is a decisive milestone wit…
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ISPE Releases Cleaning Validation Guide
The International Society for Pharmaceutical Engineering (ISPE) has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitione…
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Strategizing for Rapid Changeovers in Biologics Manufacturing
In fact, instead of weeks of review, a facility of the future can achieve real-time release without quarantining the product, notes Nestola. “In addition,” he says, “use of analysis of the data collec…
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Conclusion
This review has demonstrated that SPR is a rapidly developing technique typically used for characterization of protein interactions and in screening for selection of antibodies or small…
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A Look into the Future of Biopharmaceutical Quality
Schniepp (RCA): I think the quality unit will evolve to be a more hands-on review of the product attributes. The quality unit will need to be equal partners with manufacturing to be able to release pr…
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FDA Framework Spurs Advanced Therapies
This program is designed to expedite the development and review of regenerative medicine advanced therapies and is managed by FDA’s Center for Biologics Evaluation and Research (CBER). Applicants that…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Similar to FDA support for breakthrough therapies, the RMAT designation offers early interactions with FDA staff and the potential for priority review and accelerated approval based on strong prelimin…
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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 …