Guest Columns
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New FDA Draft Guidance: Data Integrity For In Vivo Bioavailability And Bioequivalence Studies
5/16/2024
The FDA's new draft guidance emphasizes maintaining data integrity throughout bioavailability/bioequivalence studies and provides recommendations for applicants and testing site management. The public comment period ends July 3.
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How To Unlock Efficiency In MES Integrations
5/16/2024
This article outlines the significant benefits and framework for manufacturing execution system (MES) integration with systems such as enterprise resource planning.
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Nitrosamines: New WHO Guidance Provides Expanded Risk Assessment Considerations
5/6/2024
Nitrosamines are potential contaminants of drug products. Contamination can occur from synthesizing APIs and excipients, from leaching into the product from primary packaging, and more.
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SUS, PAT, And Other Tech Advancing Upstream Bioprocessing
4/26/2024
As the sector grows, technology and techniques are becoming more sophisticated, including single-use systems, automation, and bioreactors.
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Integrating Quality Processes And Documentation After A Merger
4/25/2024
If your company is undergoing a merger, you must juggle operations while ensuring minimal disruptions. You'll need a holistic view of QMS and SOPs to harmonize procedures.
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GMP Plant Uniform Lockers And Procedures: Best Practices
4/22/2024
As the use of GMP plant uniforms has gained acceptance, locker room layouts have arisen across companies and sites. This article examines alternatives and optimized approaches.
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What Time Is Best To Bring My CDMO On Board?
4/17/2024
The answer might be sooner than you think and entail more transparency than you're used to.
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FDA Publishes Final Guidance On Reporting Listed Drug Amounts
4/10/2024
Despite earlier efforts to shore up the U.S. drug supply chain, COVID-19 still brought shortages. A new FDA reporting system aims to reduce future supply risks.
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2024 CIO Survey Reveals IT Budgets, AI Priorities For Life Sciences Companies
4/9/2024
Clarkston Consulting conducted its third annual Chief Information Officer (CIO) Survey to understand IT budgets of life sciences companies, how AI priorities fit into those budgets, and more.
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Managing Supply Chain Risks Using Relational Risk Analysis
4/5/2024
In the bio/pharma and medical device industries, you can easily model, understand, and manage supply chain risks using relational risk analysis. Here's how.