Industry Insights
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Breeze Through Surprise Audits — Take These 5 Actions Now
6/8/2023
Summer is here! That means you might hear the dreaded words, “Surprise! We are coming to audit you!” Whether it’s a client, supplier, or regulatory agency calling for an audit, those words can strike fear in even the most organized companies. But not if you're prepared by taking these five action items now.
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Build A Vial-Stopper Combination Suitable For Drug Product Storage At -80°C
This study worked to determine if the chosen vial-stopper-seal combination will remain integral while frozen at -80°C, under studied conditions, when the appropriate materials, processing, and sealing conditions are applied.
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Is Continuous Manufacturing A Good Fit For Generic Drug Products?
7/25/2019
Continuous manufacturing (CM), though well recognized by regulators and technology providers as a means to improve product quality, has seen a slow pace of adoption within the generic manufacturing sector. This article discusses the challenges and mitigation strategies for adoption of CM by generic drug product manufacturers.
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They’re Not Mind Readers: Have You Told Your Suppliers What You Want?
12/30/2019
There are many reasons for issues to crop up in a supply chain. For some, there aren’t realistic, economical work-arounds available to every company to mitigate all consequences.
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How To Build An FDA Audit-Ready QMS: A Primer
3/21/2018
This article will address the roles of quality control and quality assurance, how these roles are related and how they are different and how they must work together to create a sound quality management system.
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Key Considerations For A Successful Pharmaceutical Tech Transfer
5/5/2021
A pharmaceutical technology transfer can also mean knowledge transfer about existing products from one manufacturing site to another by a facility change, a company merger, an acquisition, or a shift to a contract manufacturer (CMO).
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3 Ways To Mitigate Data Manipulation Risk In Drug Development
1/6/2021
A critical output of the drug development process, besides the compound itself, is data. We highlight specific actions to mitigate your organization’s risk of data manipulation and three key steps in tackling this problem.
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What You Need To Know About Manufacturing OTC Products
5/4/2021
As more medications move to OTC status, people are interested in playing a more active role in managing their health and controlling their healthcare choices. However, self-medication comes with risks.
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Powder Characterization Techniques For Predicting Segregation
1/4/2011
The theme of this current series of editorials has been material characterization for specific processes or unit operations. This last contribution, on the topic of segregation, fits into this category, even though, unlike the other processes discussed, segregation tends to be unplanned and/or undesirable -- or indeed both! In the manufacture of pharmaceuticals, segregation in a feed hopper or feed frame, or during conveying/transport, can have a catastrophic effect on content uniformity. It may also impact processability. By Tim Freeman, Freeman Technology
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The Relationship Between GMP And CMC - And The Team That Ties It Together
9/16/2020
While GMP adherence might seem like a prescriptive series of boxes that biopharmaceutical producers are responsible for checking off, there’s a bit more strategy involved as it relates to a company’s overarching CMC (chemistry, manufacturing, and controls) strategy.