Search results for " risk-based"
Article
Managing Risk in Raw Material Sourcing
Teva, meanwhile, has developed a systematic risk-based approach for reviewing suppliers, including their efforts in serialization (5).
References
1. “Best Practices for Effective Excipient S…
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Using a safety-by-design approach that is risk-based can help focus and coordinate efforts to address the most important factors. Successfully avoiding exposure to animal-sourced materials requires th…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
• Risk-based testing augmentation: specific virus testing (e.g., by polymerase chain reaction [PCR] or other technology) should be implemented, if justified by risk assessment. This testing should inc…
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A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
The need for harmonized standards was emphasized, but lacking any immediate consensus, the panelists recommended that drug companies take a risk-based approach to evaluating single-use system componen…
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Innovative Therapies Require Modern Manufacturing Systems
Both Republicans and Democrats want the GAO to update its 2010 report on FDA’s overseas regulatory capacity, with a focus on agency progress in implementing a risk-based inspection system and in staff…
Article
Framing Biopharma Success in 2016
Quality warning signs
FDA plans to use quality metrics to develop risk-based inspection scheduling of drug manufacturers; to improve its ability to predict and mitigate drug shortages; and “encour…
Article
Aseptic Processing: Keeping it Safe
By Randi Hernandez, BioPharm International
Humans represent the greatest risk for microbial contamination in an aseptic process.
Aseptic processing has garnered some increased scrutiny…
Article
Breakthrough Drugs Raise Development and Production Challenges
The initiative, he noted, requires risk-based assessment strategies and a product quality lifecycle management plan, combined with clear analysis of what can be evaluated during review, and what can b…
Article
Biopharma Advances Demand Specialized Expertise
Integrating risk-based review, GMP inspection, implementation of quality by design, and the new FDA process validation guidance within one office is expected to significantly change the biopharmaceuti…
Article
Quality Systems Key to Lifecycle Drug Management
While previous ICH quality standards have focused on using science- and risk-based approaches in new drug development, the Q12 document aims to address more directly the commercial manufacturing phase…