Industry Perspectives
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Key Considerations In Selecting A Robotic Solution For Endotoxin Testing
7/6/2023
The U.S., European, and Japanese Pharmacopoeias require testing for bacterial endotoxin in pharmaceutical products, water, intermediates, and medical devices. This article shares key criteria for those of us who are looking to select an automated/robotic endotoxin detection system.
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Optimizing CMO Partnerships
7/5/2023
Industry experts discuss best practices and tips across a range of topics, including program management, automation, and secondary services.
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A Practical Look At Data Governance In The Life Sciences
6/13/2023
Without solid data governance, there is an increased risk of data discrepancies, misinterpretation, or even loss, which can hamper the development process. But what exactly is data governance? This expert shares a handy list of key considerations and strategies for moving forward.
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All You Need To Know About Contamination Control Strategies, Part 2
5/22/2023
In the second of this two-part series, microbiology and contamination control specialists Vanessa Figueroa and Greg Gibb continue discussing best practices in contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I. Discussion includes the elements typically found in a CCS, who in your company is responsible for developing the CCS, how often it needs to be evaluated, and more.
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All You Need To Know About Contamination Control Strategies, Part 1
5/12/2023
In the first of this two-part series, microbiology and contamination control specialists Vanessa Figueroa, Rebecca Brewer, and Greg Gibb, Ph.D., discuss best practices in developing contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I, Manufacture of Sterile Medicinal Products.
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Harnessing The Future Of Digital And Smart Manufacturing Of Medical Devices
5/2/2023
There are many benefits to medical device manufacturers that embrace digitalization and smart manufacturing. Not only does this transformation streamline work, which reduces errors and saves time and money, but it also expedites the expansion of a company’s product portfolio.
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Increase In FDA Inspections + Whistleblower Complaints = Heightened Compliance Scrutiny
3/27/2023
We are seeing a significant increase in manufacturing facility inspections by the FDA and other health authorities globally. We are also seeing an uptick in whistleblower complaints. Why? And how can you navigate it? This article examines the issue.
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Dispelling 4 Common Myths Of Data Quality Governance
3/9/2023
Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.
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ICH Guideline Q9(R1) On QRM, Part 2: Subjectivity & Supply Continuity
3/7/2023
The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management, Q9(R1), was adopted on January 18. This article focuses on the guidance's new topics of subjectivity and the role of QRM in addressing product availability risks.
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ICH Guideline Q9(R1) On QRM, Part 1: Formality & Risk-Based Decisions
2/28/2023
The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management (QRM), Q9(R1), was adopted on Jan. 18, 2023. While the primary principles of QRM in this new version remain consistent with the original 2005 document, the revised guidance has four new subsections. This article examines the topics of formality and risk-based decisions.