Industry Insights
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5 Important Takeaways From The FDA's Revised Quality Metrics Guidance
2/23/2017
On November 23, 2016, FDA published Submission of Quality Metrics Data, a draft guidance that addresses industry comments on an earlier draft guidance titled Request for Quality Metrics (2015). This article discusses the most significant differences between the two documents and what pharma manufacturers and CMOs should take away from these changes.
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Navigating China's Biologics Approval And Accelerated Pathways
3/8/2024
Pharma companies doing business in China have four key routes to register drugs faster than the standard ways. This discussion breaks down accelerated pathways and offers tips on how to approach them.
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Packaging Good Manufacturing Practices (GMPs) For Medicinal Products
1/6/2020
Has your primary packaging materials supplier established, implemented, and maintained an adequate quality management system? The requirements of ISO 9001 may not provide the necessary levels of GMPs and rigor to ensure the packaging materials are adequate for their intended use.
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The Environmental Impact Of Biopharma Continuous Manufacturing
8/8/2022
One aspect of biopharma continuous manufacturing (BCM) often overlooked is its environmental impact compared to that of a similar batch process. In comparing the two, there is much that needs to be considered. This article is the first in a two-article series and discusses key considerations of both processes and provides a deep-dive into water usage.
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5 Steps To Build A Quality Culture That Supports Data Integrity
9/20/2016
When it comes to building a culture of quality, many companies ask, "Where do we start?” For those looking to instill good practices that will ensure the integrity of data, there are a wealth of recent resources to review.
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Partnering At Every Stage: Providing Capable Capacity For Manufacturing
Finding a CDMO partner with the requisite expertise, materials, external supply chain, and capacity is key to maximizing a therapy’s chances of commercial success.
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What Celgene Corp. v. Peter Means For Biosimilar Developers
9/10/2019
A recent decision by the U.S. Court of Appeals for the Federal Circuit has indicated that pharmaceutical makers with patent protection are unlikely to receive any compensation from the government for the loss of their patents during inter partes review (IPR) decisions by the Patent Trial and Appeal Board (PTAB).
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Understanding FDA’s Quality In 510(k) “Quik” Review Program Pilot
11/28/2018
On Sept. 6, 2018, FDA announced the launch of a new pilot 510(k) program. This initiative, the Quality in 510(k) “Quik” Review Program Pilot, proposes an alternate pathway to regulatory submission and approval for medical devices. Quik is in its early stages and is therefore limited in scope, but it nonetheless offers another approach to premarket notification. This article examines what makes Quik different from traditional 510(k) submissions, plus its benefits and challenges for medical device manufacturers.
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The No. 1 Most Common Problem In FDA GMP Inspections
6/20/2022
With issues involving quality responsibilities and procedures at the top of the FDA warning list, we uncover where the solution to make this problem a thing of the past.
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Yugos & Dueseys: What “Classic” Cars Can Teach Us About Aging Facility Risks
12/14/2016
With an increasing number of pharmaceutical plants having been in service for decades, the topic of aging facilities has become a major concern for regulatory agencies. And rightfully so — aging facilities can contribute to quality issues and drug shortages, among other problems. But what exactly is an aging facility?