Search results for "regulatory"
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American Society of Mechanical Engineers
The American Society of Mechanical Engineers (ASME) is a not-for-profit membership organization that enables collaboration, knowledge sharing, career enrichment, and skills development across all en…
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The Pharmaceutical Manufacturers Association
The Pharmaceutical Manufacturers Association (PhRMA) was founded in 1958. Its name was changed to the Pharmaceutical Research and Manufacturers of America in 1994. Headquartered in Washington, DC, P…
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World Health Organization
The World Health Organization (WHO) is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shap…
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European Medicines Agency
The European Medicines Agency is a decentralized agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical compa…
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Quality Considerations for Using AI in Bio/Pharma
Schniepp, distinguished fellow at Regulatory Compliance Associates, stresses that a robust quality management system and document control are necessary when adding AI to a process. “I also worry about…
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Moving Biosimilars Forward in a Hesitant Market
“There’s so much work that goes into demonstrating, analytically, that a product is comparable or similar to its reference product in order to achieve that type of regulatory approval,” Gabrielson sta…
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Genetic Vaccine Platforms Demonstrate Their Potential
“The availability of trained, regulatory-compliant GMP manufacturing staff and quality control and quality assurance personnel is a critical success factor,” he says. Much investment in facilities wil…
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Remote Monitoring and Big Data Advance Upstream Automation
…contamination risks, batch characterization, process integration issues; infrastructure challenges; regulatory authority resistance; and access to people with the right combination of skills and abil…
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Technology Innovations Improve Process Chromatography Performance
“We are also seeing that, as regulatory limits impose restrictions for ensuring customer safety, like toxicology and cleaning validation for GMP [good manufacturing practices] environments, off-the-sh…
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Scalable Viral Vector Manufacturing
From a regulatory perspective, it is recommended to avoid any raw materials that are of animal origin such as serum and other components as these could potentially contain adventitious agents.
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