Contributing Editors
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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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The EU’s Ban On TiO2 In Food May Impact Pharma. Here’s What You Should Know.
4/18/2024
Titanium dioxide (TiO2) is used as a food additive and OSD pharmaceutical excipient. In 2020, the European Food Safety Authority noted data gaps regarding particle size, which can affect its toxicological properties, so the European Commission banned it as a food additive. Here's how this could impact pharma.
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Innovating Bioequivalence: A Novel Approach To Developing Complex Generic Dosage Forms
4/16/2024
Achieving bioequivalence for complex generics is an intricate task. This article describes an approach using in vitro–in vivo correlation, PBMK modeling, and more.
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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.
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Designing Highly Agile Bio/Pharma Manufacturing Facilities
4/5/2024
In bio/pharma, agile manufacturing is achieved through multipurpose designs that support a variety of unit operations manipulated and operated as independent yet connected modules.
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A Quality-Led Approach To Drug Production Facility Design
3/26/2024
There are important considerations that architects and engineers can miss if they don't include the quality perspective. It's better to involve quality at the outset rather than discover omissions when it's too late.
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Quick Takes From Takeda Austria’s Annex 1 Rollout
3/25/2024
At ISPE's 2024 Aseptic Conference, Takeda Austria's site head spoke about lessons learned from Annex 1 implementation. We caught up with her and asked for the highlights.