Articles From Our Expert Network
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Using System Risk Structures To Understand And Balance Risk/Benefit Trade-offs
4/23/2021
The ICH 31000 guidance defines a risk as the “impact of uncertainty on objectives.” As a follow-up to his article on why we should replace the RPN with the adjusted risk likelihood (ARL), Mark Witcher describes how system risk structures can be used to simultaneously understand and manage both risks and benefits.
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Tools And Best Practices For Trending Environmental Monitoring Data
4/11/2021
Environmental monitoring (EM) trending is an essential component of the EM program to evaluate the overall health of the facility in terms of microbial control. Part 1 of this series looked at the regulations and guidelines around EM. This article discusses tools and best practices for using the trends to ensure establishment of an efficient environmental monitoring program.
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Rating Risk Events: Why Adjusted Risk Likelihood (ARL) Should Replace Risk Priority Number (RPN)
4/7/2021
While the RPN primarily represents a risk event’s severity, perhaps a more important attribute to focus on is the risk event’s likelihood of occurrence. In this provocative article, Mark Witcher, Ph.D., proposes an adjusted risk likelihood rating approach that emphasizes a risk event’s likelihood of occurrence.
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An Introduction To Trending In Environmental Monitoring Programs
4/5/2021
Trending environmental monitoring (EM) data is a regulatory requirement. However, it is useful in obtaining significant information about the facility. Trends can help determine if your facility is in a state of microbial control and relay the data to facility management in a meaningful format. In this two-part series, Crystal Booth of PSC Biotech looks first at the regulations and guidelines around EM.
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Complying With Batch Release: Auditing Electronic Batch Records
3/26/2021
This article presents some advice for auditing electronic batch records to assess their current good manufacturing practice (cGMP) status. This is useful in the qualification stage and essential once the electronic record system is in operation.
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Establishing An Effective Calibration Program
3/15/2021
Calibration is the comparison of inspection, measuring, and test equipment against a traceable reference device to determine if accuracy and precision limits are met. It is one of the fundamental, yet often neglected requirements for GMP. Several international standards, regulations, and guidances provide requirements for an effective calibration program.
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11 Critical Steps To Manage Solvents During API Manufacturing
3/5/2021
Manufacturers and distributors use multipurpose tankers for organic solvents for the manufacturing of APIs and associated intermediates. This presents a cross-contamination risk that might go undetected when the solvent is tested before offloading into a manufacturing site distribution system. This article explores the risks and mitigation options available to API manufacturers.
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Changing Perceptions On Bioprocess Intensification, Continuous Processing
3/1/2021
Process intensification and continuous bioprocessing are concepts with inconsistent definitions. What's included often varies greatly and, in some ways, has become more about aspirational goal-setting than actual innovation adoption. Here, BioPlan Associates assesses the changing perspectives of 122 bioprocess decision-makers.
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Important cGMP Considerations For Implementing Electronic Batch Records
2/26/2021
Mistakes in batch records can have considerable consequences for the release of medicines in terms of delays and rejections. Errors can be minimized through the implementation of electronic batch records. However, with any electronic system within the pharmaceutical industry, the requirements of current good manufacturing practice (cGMP), including those of data integrity, need to be met.
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Future Delivery Models For ATMPs: Practical Considerations
2/17/2021
With a small number of approved cell therapies/ex-vivo gene therapies, and with those approved therapies reaching small patient populations, there is not a proven strategy to answer the questions about large-scale commercial manufacturing. The developers of these processes are taking different strategies for commercial manufacturing as they weigh several factors.