Industry Insights
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Make The Service Agreement Work For You And Your CDMO
12/14/2022
Knowledge of the applicable rules and legal challenges, as well as ways to ensure the enforcement of proprietary rights, requires companies to invest in negotiating and drafting robust and balanced CDMO service agreements. This article provides practical tips (for both the principal and the CDMO) for drafting these vital legal agreements.
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Preventing Cross-Contamination – Operating Beyond cGMP
One critical outcome universally accepted by the pharmaceutical industry is that cross-contamination of drug substances and products in manufacturing lines cannot occur. However, the conditions driving modern pharmaceutical development and manufacturing have increased the risk of cross-contamination.
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High Shear Mixer Considerations For The Cannabis Industry
4/5/2023
Explore high shear mixers and how they can be used in a variety of ways to create cannabis-infused products.
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Respirator fit testing: choosing the best method
7/31/2000
Tight-fitting respirators that fit correctly will protect workers better than respirators that don’t fit properly around the nose and mouth...
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Harmonization Horrors: When Quality System Alignment Goes Wrong
3/6/2020
This article is the first in a two-part series explaining how to successfully harmonize disparate quality systems when two companies merge. Here in Part 1, we will focus on what not to do when reconciling two quality systems, providing real-life examples — drawn from the author’s experiences — from each phase of QMS harmonization.
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What Is The Link Between Quality Metrics, Data Integrity, And Quality Culture?
9/7/2018
Among the current and emerging topics of interest to the biopharma industry, quality metrics, quality culture, and data integrity are of particular concern to both the companies and regulatory authorities. To understand how these three topics relate to each other, it is important to understand some of the history that led up to today’s environment.
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Small-Scale Aseptic Filling Technology Considerations
2/23/2023
Small-scale aseptic filling presents a unique set of challenges. Learn what to look for when evaluating small-scale aseptic filling technology.
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Ensuring The Greatest Return From Your Poorly Soluble Molecule
The sheer number of potential strategies for improving the solubility of a compound can overwhelm many developers, leaving them unsure how to choose a path forward.
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Method Transfer – When, Why, How?
2/16/2022
A formal method transfer is an exercise that demonstrates and documents that a method has been successfully qualified in another laboratory to provide accurate and repeatable results.
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3 Keys To Meeting Regulators’ Data Expectations
12/28/2021
To improve the actionability of data, pharma organizations can take the following three fundamental steps that will enhance their ability to leverage it to achieve quality and compliance goals.