Featured Pharma Online Editorial
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What Do Artificial Intelligence And Continuous Validation Have In Common?
6/2/2021
Validation documentation can be reduced by applying automated testing and deployment. This article discusses ISO standards that address risk management, IT alignment with software engineering, opportunities for continuous lifecycle management, and how artificial intelligence (AI) can help.
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Statistical Methods For Comparing Small-Scale Models To At-Scale Biopharmaceutical Manufacturing
5/26/2021
As the final article in a three-part series that summarizes the discussions and exchanges of a BioPhorum Development Group workstream on small-scale model (SSM) justification, this article discusses statistical methods for comparing SSM outputs to at-scale outputs and covers descriptive statistical methods, inferential methods, difference tests, equivalence tests, and more.
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A LIMS Audit Framework: What To Audit & How To Prepare
5/24/2021
Laboratory information management systems (LIMS) are inevitably the subject of regulatory focus and audit. This article considers what to audit and how to audit a LIMS, presenting a framework useful to those planning to undertake a LIMS audit and for laboratory managers who need to prepare.
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Planning & Executing Small-Scale Model Qualification For Upstream & Downstream Biopharma Processing
5/19/2021
As the second article in a three-part series that summarizes the discussions and exchanges of a BioPhorum Development Group workstream on small-scale model (SSM) justification, this article covers the current opinion on how to execute small-scale model qualification for both upstream and downstream SSMs and analytical setup.
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Implementing Small-Scale Models For Biopharmaceutical Development
5/12/2021
Small-scale models (SSMs) are widely used for process development and optimization, scale-up, technology transfer, process characterization, process validation, and more. This article from a BioPhorum Development Group discusses the applications of the models, including viral clearance, quality oversight, and design considerations for justification of SSMs.
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Are You Approaching LIMS Validation Correctly?
4/26/2021
Laboratory information management systems (LIMS) are an established part of larger laboratories. However, different LIMS vary in their scale, functionality, and quality. This article considers the essential validation criteria for LIMS to ensure the system functions as a compliant component in the digital backbone of the modern laboratory.
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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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How to Ensure Your Quality Culture Assures Data Integrity
4/14/2021
One solution to ensuring data integrity is to automate the process, essentially removing the human element. But not all instances of data generation/capture can or should be automated. With humans – our team members – engaged in data generation/capture, the quality culture is a major pathway to assuring our data have integrity.
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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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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.