Search results for " meeting" in Articles / App Notes
Article
Efforts Accelerate to Streamline Postapproval Change Process
The EWG is circulating draft proposals with the aim of reaching consensus on a Step 1 standard at the ICH November 2016 meeting in Japan. If successful, the group anticipates approval of a final stand…
Article
Platform Approach Speeds Process Development
… reliable evidence that process parameters and associated critical product attributes are capable of meeting the anticipated product quality profiles.
Conclusion
With the increasing number of…
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Innovative Therapies Require Modern Manufacturing Systems
CDER further aims to encourage manufacturer adoption of cutting-edge pharmaceutical production technology by providing assistance in meeting regulatory requirements for innovative systems. A draft gui…
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Biopharma Advances Demand Specialized Expertise
The expanding capacity needs result in partnerships between clients and their contractors with the systems, experience, and expertise to achieve the quality and speed required, while meeting all regul…
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Quality Systems Key to Lifecycle Drug Management
An ICH expert working group discussed a Q12 concept paper in Lisbon, Portugal in November 2014, and a more detailed proposal is scheduled for further discussion at the June ICH steering committee meet…
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Modern Manufacturing Systems Key to FDA Quality Initiative
She reiterated this approach at the February 2015 annual meeting of the Generic Pharmaceutical Association, urging development of continuous manufacturing operations that can achieve consistent produc…
Article
USP Publishes Monoclonal Antibody Guidelines
Mar 02, 2015
By Dale Schmidt, M.S., Anita Y. Szajek, PhD, Fouad Atouf, PhD, Tina S. Morris, PhD
BioPharm International
Volume 3, Issue 28
As FDA gears up towards approving biosimilar dru…
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New Era for Generic Drugs
Specific goals for reviewing ANDAs kick in this year, and manufacturers have concerns about OGD meeting the schedule. An unanticipated problem is that more than 1400 applications were filed this past …
Article
Viral Clearance Challenges in Bioprocessing
“Comprehensive test design resulting from thorough process understanding and communication between the biologics manufacturer and the virus clearance testing lab is essential to meeting these goals.”
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Article
Continued Process Verification for Biopharma Manufacturing
From presentation at 10th APIC/CEFIC meeting, “FDA’s Quality Initiatives—An Update” by Moheb M. Nasr
About the Authors
Jeff Fleming is an independent writer with over 30 years of experience in…