Articles From Our Expert Network
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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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The 5-Step Checklist For A More Mature, Robust Quality Management System
8/20/2021
Whether you are preparing for a pre-approval inspection, have the corporate desire for continuous inspection readiness, or are engaged in a LEAN initiative to clean up and strengthen your quality management system (QMS), further maturing your QMS can be helpful to ensuring a robust, comprehensive, and compliant QMS.
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Prefilled Syringes: Best Practices For Using X-Ray Analysis To Assess Container Closure Integrity
8/18/2021
The process of assessing integrity of the filled syringe is generally more complex than the process of assessing glass vials due to the presence of more sealing areas. This article looks at the broad requirement, together with a recent innovation for integrity testing based on X-rays.
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EMA Publishes Guideline On Quality Documentation For Medicinal Products
8/2/2021
This new EMA guideline will become effective on January 1, 2022. It describes the information that should be presented in the quality part of a marketing authorization dossier for a medicinal product when it is used with a medical device and/or as part of a medical device. Medicinal products are similar to "combination products" referred to by the US FDA.
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10 Critical Validation Parameters For Microbiological Experiments
7/26/2021
In studying a microbiological method, different validation parameters require assessment. These are variables or factors that can be controlled, changed, or measured in the experiment. This article outlines the key parameters to consider.
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What To Expect From A Remote Inspection -- & How To Navigate It
7/23/2021
Regulators have moved toward remote inspections since the pandemic began, and this is likely to continue. This article presents an overview of the remote inspection process and provides advice on how to prepare for and deal with the inspection on the day, as well as how to respond to any concerns raised following the audit.
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The 8-Step Checklist To Write Effective Investigation Reports
7/16/2021
It’s always best to prevent the need to investigate a non-compliance, but if you experience a non-compliance, it’s necessary to quickly and effectively perform an investigation. The investigation report needs to be clearly understandable to anyone reviewing the report, and hopefully you'll also learn enough to make sure the non-compliance doesn't recur.
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FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products
7/14/2021
At the end of June, the FDA released a new guidance to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application. This article summarizes the guidance.