Featured Pharma Online Editorial
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Pharmaceutical Quality Compliance In 2022: Data Is Paramount
2/11/2022
Pharma quality and compliance leaders must anticipate potential manufacturing issues before they happen by leveraging risk-based methodologies, continuously monitoring their systems, and tracking the profusion of data generated during the process. This article outlines the potential of data and analytics to improve quality performance.
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Failed Process Performance Qualification: Lessons Learned
1/24/2022
Recently, Immunovant was working on a low demand fc fusion protein that was produced in a small number of lots with a very small clinical history. The process performance qualification (PPQ) didn’t go as planned; quality attributes dropped to unacceptable levels and the cell health declined. This is the story of how the team identified the problem and then fixed it.
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How To Enable Your Quality Risk Management Lifecycle
11/29/2021
The topics covered in this article represent some of the common risk management pain points and mechanisms to overcome these challenges, focusing on the foundation of quality risk management (QRM). This includes using consistent terminology, determining risk strategy, implementing QRM, and the advantages of early implementation.
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The Essential Components Of A Sterility Assurance Program
10/15/2021
The first step in developing a sterility assurance program is to list each step in the process, beginning at the point of use and ending in sterile storage. Each step should be evaluated for ways to prevent contamination in the manufacturing process or environments. This article shares the components of a holistic sterility assurance program for an aseptic manufactured product.
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COVID-19 Vaccine Benefit-Risk Analysis/Ratio Using Real World Data
10/6/2021
For National Immunization Awareness Month, we're highlighting timely vaccine manufacturing-centric articles such as this one, covering a method by which benefit-risk analysis can be objectively carried out to arrive at a benefit-risk ratio. The article provides a relevant, contemporary example of how it can be used to calculate COVID-19 vaccine benefit-risk.
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A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part I
10/4/2021
This article introduces a novel model of benefit-risk by taking a bottom-up approach using the _risk of the therapy_ and comparing it to _risk of no therapy_ to quantify risk and benefit with the same scale. This overview is relevant not only to the pharmaceutical and biotech industries, but also the medical device industry.
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FMEA Vs. System Risk Structures (SRS): Which Is More Useful?
9/24/2021
In this article, Mark Witcher, Ph.D., discusses the many failure modes of FMEA and risk priority number (RPN), comparing and contrasting it with system risk structures (SRS) and adjusted risk likelihood (RPN). He concludes that one of these is more useful than the other for pharma and medical devices; which one is it?
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9 Pitfalls To Avoid In Data Integrity in Pharmaceutical and Device Development & Operations
9/22/2021
The first article in this series examined 5 common misconceptions in data integrity (DI). In this article, the author now shares 9 example areas where he has seen significant DI implementation problems in pharmaceutical and medical device companies.
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5 Misconceptions About Data Integrity In Pharmaceutical And Device Development & Operations
9/15/2021
Data integrity (DI) issues in pharma and medical devices have always been there, but in my experience as a consultant, these issues have increased in frequency more recently, thus moving them to the forefront. In this article, I explain five misconceptions about data integrity in our industry.
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Vaccine Manufacturing: Harnessing Lab Deviations
9/8/2021
For National Immunization Awareness Month, we're highlighting timely vaccine manufacturing-centric content such as this from Tunnell Consulting's Bob Johnson. The presence of deviations may seem inevitable, yet COVID has brought to light the question of how vaccine manufacturing sites can manufacture more vaccines, more efficiently. This article explains how.