Featured Pharma Online Editorial
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Advancing The State Of Aseptic Processing: Let’s Get Serious
11/23/2020
It seems pitiful that, for whatever reason, industry has failed to universally adopt more effective technologies to control contamination resulting in safer sterile drugs. On the other hand, the regulators must share substantial blame because of their historically lukewarm acceptance of emerging and even established advanced technologies.
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Moving Beyond Human Error In Biopharma Investigations And CAPA Programs
11/16/2020
Human performance improvement requires special focus and deliberate action by management to move from an old construct of investigating error as a human failure to an new construct where error is a symptom of a problem to be understood, linked to the context in which the error took place, and it is the starting point of the investigation, not its conclusion.
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Revising Annex 1: A Case Study In Controlling Operating Risks By Understanding Uncertainty
11/13/2020
Unfortunately, the pharmaceutical industry does not understand how to control a risk’s likelihood of occurrence. The current draft of EU GMP Annex 1 is an example of the industry’s focus on a risk’s severity while not understanding or evaluating a risk’s uncertainty and thus defaulting to using the precautionary principle for guidance.
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Human Performance In Biopharma Operations — Your Problem Isn’t Error
11/9/2020
Part 1 of a two-part roundtable discusses key drivers for human performance improvement, lean manufacturing and human performance programs, and perspectives on human performance in the context of the rapid scale-up and production of COVID-19 therapeutics and vaccines.
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Unpacking FDA’s New Guidance On Controlling Nitrosamine Impurities In Drugs
9/10/2020
On Sept. 2, 2020, the Federal Register announced the availability of a final FDA guidance, "Control of Nitrosamine Impurities in Human Drugs." This guidance is immediately effective and was not subject to the usual comment period “…because of the importance of providing timely information to manufacturers regarding risk assessments, testing, and other appropriate actions they should take."
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Making FMEA More Robust With HACCP
8/27/2020
Risk priority number scores and criticality analysis are frequently used to quantify risks for users, designs, and processes. However, these traditional failure mode and effects analysis (FMEA) techniques often fail to fully document risks associated with contamination. To complement FMEA, consider borrowing a risk-management technique from the food industry.
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Environmental Monitoring And Sterility Assurance Control For Medical Devices And Combination Products
8/11/2020
The establishment of an environmental monitoring and microbiological control program for sterile medicinal devices is necessary to ensure microbiological safety and finished product quality. The level of environmental control is primarily dependent on the method of product sterilization.
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System Risk Structures: A New Framework For Avoiding Disaster
7/13/2020
Risks are ubiquitous, occurring in every aspect of our personal and professional lives. This article describes how pharmaceutical development and manufacturing risks can be easily understood and effectively managed using straightforward concepts.
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What Managing Personal SARS-CoV-2 Risks Can Teach Us About Managing Pharma Risks
6/12/2020
This article describes how the basic principles of managing personal risks of being infected by a respiratory virus can be used to manage risks for developing and manufacturing pharmaceuticals. The goal is to elucidate the basic principles of understanding, managing, and communicating a wide variety of risks from the trivially simple to the very complex.
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Knowledge Management — Opportunities & Challenges For Legacy Drug Products
6/1/2020
This article will explore specific challenges of managing knowledge in a legacy manufacturing environment and propose viable, practical solutions that have been found to be effective. These solutions allow practitioners to increase product and process understanding as well as performance.