Material Handling Featured Articles
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All You Need To Know About Contamination Control Strategies, Part 2
5/22/2023
In the second of this two-part series, microbiology and contamination control specialists Vanessa Figueroa and Greg Gibb continue discussing best practices in contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I. Discussion includes the elements typically found in a CCS, who in your company is responsible for developing the CCS, how often it needs to be evaluated, and more.
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Not All Plate Counting Technologies Are The Same
5/18/2023
While rapid microbiological methods have advanced, most microbiology lab tests remain reliant upon assessing microbial growth on agar plates. Discrepancies with plate counting, together with the limitations of human vision, have led to regulatory concerns. This article shares the advantages of automated colony counters. Keep in mind that not all automated plate counters are the same, though — you'll want to look for important functionality.
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A Digital-First Approach To Bio/Pharma Manufacturing Operations
5/10/2023
Features such as real-time data monitoring, cloud solutions, and process integration comprise a digital operational excellence approach that adds value. But successful deployment of these and other digital solutions requires careful, cross-functional collaboration across the full life cycle of the project.
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FDA Issues New Guidance On Discontinuance Or Interruption In Manufacturing Of Finished Products Or APIs
5/4/2023
In April 2023, the FDA issued an updated guidance superseding and replacing the previous 2020 document about managing drug shortages and explaining what was expected of industry and how the agency was going to manage the shortfalls. This article summarizes the guidance in a helpful FAQ format.
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India’s CROs & CDMOs Come Of Age In The Global Marketplace
5/4/2023
Most of the top 10 pharmaceutical companies and many large biotech companies today get a portion of their preclinical/clinical research, drug development, and/or manufacturing done in India. While a low price is the initial attraction, there are additional factors that can be more meaningful.
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5 Emerging Trends In Complex Small Molecule Drug Production
5/3/2023
The small molecule landscape is changing in terms of drug product complexity, molecule potency, manufacturing trends, and industry makeup. How the industry responds will shape the next chapter of small molecule drug development.
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Recent FDA Inspections In India Indicate New Focus On Tablet Press Operations
4/21/2023
Over the past few years, the FDA investigators in India have shifted their focus away from laboratory and data manipulation and toward a closer look at tablet press operations. The new interest centers on critical process parameters, the automatic weight control system, and more.
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Risk-Based Strategies For Revalidating Bio/Pharma Equipment & Systems
4/20/2023
While equipment and systems validation is a regulatory requirement, it would take thousands of annual tests to retest all equipment and systems. BioPhorum shares risk-based approaches to new product introduction, controlled temperature chambers, sterilization processes, and more.
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Strength Biowaivers For Immediate Release Oral Solid Drug Products: European & American Perspectives
4/13/2023
A strength biowaiver is usually claimed for an additional strength when bioequivalence has been established for one strength and the biopharmaceutics classification system biowaiver is not applicable. Six factors need to be considered with additional strength biowaivers, and this article shares the regulatory requirements in the U.S. and Europe.
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Increase In FDA Inspections + Whistleblower Complaints = Heightened Compliance Scrutiny
3/27/2023
We are seeing a significant increase in manufacturing facility inspections by the FDA and other health authorities globally. We are also seeing an uptick in whistleblower complaints. Why? And how can you navigate it? This article examines the issue.