Editorial
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Developing & Implementing A Continuous Bioprocess Control Strategy
2/20/2024
A key challenge to better uptake of continuous processes in biologics manufacturing is the necessity to link unit operations. This article defines a standard template approach for developing and implementing a continuous bioprocessing control strategy, providing a visual and technical aid, and sharing considerations when selecting control schemes.
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Let’s Clean Up That Bioburden — The Aseptic Suite’s Persistent Plague
2/16/2024
After decades of helping to rescue biotech and pharma companies from environmental monitoring excursions, Herman and Erich Bozenhardt bring this discussion about specific problems you should avoid.
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A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis
2/16/2024
The ASTM E55 Cleaning Team, in collaboration with F04 Medical Device Committee members, felt that the commonly used three-level criticality system was inadequate for use in a science- and risk-based standard for cleaning process development, validation, and monitoring. This article will provide a detailed discussion of how science-based and data-driven criticality levels were derived, the meaning of each level, and how they can be used for guiding the selection of risk reduction and risk control measures.
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New DSCSA Guidance Details Layers Of Verification System Requirements
2/15/2024
A recent FDA final guidance interpreting the DSCSA details verification systems expectations for trading partners. Just how they should meet these expectations, however, remains unclear.
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Using Relational Risk Analysis To Control Procedure Failures
2/15/2024
In the bio/pharma and medical device industries, operating procedures guide virtually every activity and are required for compliance with good manufacturing practices. Minimizing procedure execution failures is critical. To do so, you can use relational risk analysis (ReRA).
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Assessing Cross Contamination Using Layers Of Protection Analysis For Facility And Product Safety
2/14/2024
Layers of protection analysis (LOPA) is a risk tool that focuses on the strength of controls that are currently in place and enables a cross-functional team to dive into the ways that the controls may fail. The article outlines the application of LOPA to drug product and facility cross contamination.
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Continuous Manufacturing: Many Want It, But Here’s Why Few Have It
2/13/2024
In 2023, biomanufacturers showed an increasing interest in continuous manufacturing, but uptake, believe it or not, slowed down. Let’s explore the reasons why with data from BioPlan Associates.
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Trends In FDA FY2023 Inspection-Based Warning Letters
2/13/2024
The U.S. FDA issued 180 warning letters to drug and biologics manufacturers in fiscal year 2023 (FY23) and 94 of them were based on an on-site inspection of the company. This article provides an analysis of trends and observations from the inspection-based letters, as well as additional insight on the agency’s approach to enforcement.
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Getting Out Of The Doldrums: Analyzing & Kickstarting Organizational Quality Maturity
2/8/2024
It's difficult to consider what the impact of organizational culture might be on a quality system, its effectiveness and robustness, and even its maturity state. You need a way to spot when your team is in the doldrums and kickstart quality maturity. Regulators want it, so you should, too.
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FDA Issues Final Guidance: Reformulating Drug Products That Contain Carbomers Manufactured With Benzene
2/6/2024
Benzene contamination in pharmaceuticals has led to product recalls and increased scrutiny in recent years. Recently, the FDA has asked the USP to remove a few monographs from the compendium due to safety concerns related to benzene's carcinogenic properties, and the agency has issued a new guidance to help industry navigate the reformulation of such drug products.