Search results for " regulatory"
Article
New Era for Generic Drugs
Hatch-Waxman also has generated a host of legal, regulatory, and economic issues that complicate generic drug oversight and distribution.
User fees alter landscape
The Hatch-Waxman anniversary a…
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Challenges in Analytical Method Development and Validation
In addition, this may impact the regulatory submission; however, the bottom line is if the original method isn’t accomplishing what it needs to accomplish, it needs to be modified and updated to minim…
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The Lifecycle Change of Process Validation and Analytical Testing
The 2011 guidance aligns process validation with product lifecycle principles that are now part of current regulatory thinking and principles.
CHALLENGES
BioPharm: What are the key…
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Sterilization Trends for Single-Use Consumables
The first step in establishing an effective sterilization process for SU consumables, according to James Hathcock, senior director of regulatory and validation strategy at Cytiva, is to select a steri…
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Digitalization: The Route to Biopharma 4.0
By transforming data into an intelligence-supporting decision-making tool, it is easy to realize the longstanding regulatory initiatives of process analytical technology (PAT) and quality by design (Q…
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Ensuring Viral Safety of Viral Vaccines and Vectors
However, because achieving robust clearance is challenging using chromatography, regulatory documents urge caution but remain encouraging. European guidance states that if the virus reduction is repro…
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Understanding Validation and Technical Transfer, Part 3
This information serves as the foundation for producing material for clinical studies, initial regulatory filings such as investigational new drug applications (INDs) and biologics license application…
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Putting Viral Clearance Capabilities to the Test
When applying for regulatory approval, a drug license holder must demonstrate that its proposed manufacturing process can remove or inactivate potential viral contaminants.
Viral clearance studies…
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Understanding Validation and Technical Transfer, Part I
It is not a stack of protocols and reports designed to satisfy regulatory expectations. It is not following by rote a series of “qualifications” such as design (DQ), installation (IQ), operational (OQ…
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Process Development: What May Lie Ahead in 2018?
Safety and Regulatory Concerns
As scientific breakthroughs continue to advance the biopharmaceutical industry, safety issues (new and old) must also remain a top-of-mind concern for the biopharmac…