Featured Pharma Online Editorial
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FDA Seeks Public Comment On Quality Metrics Reporting Program
3/17/2022
The FDA recently announced it is soliciting comments on changes to its previously proposed Quality Metrics Reporting Program. This article shares which primary metrics the FDA intends to collect data on as well as the FDA's questions for input. The comment period ends June 7, 2022.
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What's The Role Of Intuition When Making QRM Decisions?
2/28/2022
In Part 1 of this 2-part series, this author explained how to effectively set up your quality risk management (QRM) program for pharma and medical devices. In this article, he explains how to implement that program. For such a numbers-based field, there is still an important role for using your intuition to make QRM decisions.
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What Are Risk Appetite & Risk Tolerance In Pharma & Medical Devices?
2/23/2022
This article describes and differentiates risk appetite and risk tolerance and discusses why these two concepts are foundational to how we make risk-based decisions in pharma and medical devices. Also covered are a spectrum for risk appetite, best practices for risk communication, and events and conditions that can shape risk appetite and tolerance.
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How To Set Up An Effective Quality Risk Management Program
2/16/2022
The author of this article has taught courses on quality risk management (QRM) and its implementation as well as seen it in action in many companies. This article, Part 1 of a 2-part series, shares some of his observations and lessons learned in setting up an effective QRM program.
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Data Management: 5 Best Practices For Emerging Biotechs
2/14/2022
Whether your ambitious upcoming pharma startup or biotech has its sights set on being the world’s first in your field, or a lucrative exit through a strategic company sale, starting out with good data management practices will set you up for success for the future you envision.
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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.