Search results for " regulatory" in Articles / App Notes
Article
Best Practices in Adopting Single-Use Systems
Another positive factor has been suppliers’ increased commitment to providing a robust regulatory package. Vendors have taken on the burden of documenting their products’ suitability and safety, which…
Article
Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
Because the non-EEA authorized product would have to follow similar scientific and regulatory standards as those of the EMA, it would have to be in a country that is a member of the International Conf…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
This binary designation was usually determined during early development for the purposes of regulatory filings, relying heavily on scientific judgment and limited laboratory studies.
Wi…
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Operational Excellence: More Than Just Process Improvement
Life-sciences organizations will need such hardy cultures of quality to withstand stepped-up regulatory scrutiny. FDA Commissioner Margaret Hamburg told participants at the Annual Meeting of the Gener…
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Biosimilars Development and Supply: How Complex Can the Process Be?
A recent report (3) from the European Commission looking at Europe’s strong regulatory and commercial foundation for biosimilars found that biosimilars are improving competition in Europe and increasi…
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Prescribing Caution for Biosimilars
In statehouses around the country, lawmakers are beginning to address the complexities of cutting-edge biotech drugs and the regulatory issues related to the interchangeability of biosimilar medicin…
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Milestones and Moderate Progress in 2012 Drug Approvals
First gene therapy and plant-based expression vector products approved in 2012.
In terms of product approvals, the past year can be considered reasonably successful. Twelve biopharm…
Article
Track-and-Trace Progress Benefits Supply-Chain Security Efforts
Globally, GS1 works with pharmaceutical manufacturers, wholesalers, distributors, retail pharmacies, hospital dispensaries, trade associations, and regulatory agencies to help advance track-and-trace …
Article
How To Execute Successful Data Migrations
Successful migrations require careful planning to meet business needs and maintain data integrity.
By Art Meisler
Data migration is the unglamorous task of a system implementation. …
Article
Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
…physical sampling of powder raw materials requires rapid material usage post-sampling to comply with regulatory guidance.
The physical properties of powders require extensive clean…