Insights On Regulatory Compliance
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Eliminating USP <88> In Vivo Animal Bioreactivity Testing For Polymer Characterization
8/25/2023
There has been growing awareness about the environmental and ethical implications of plastics used in bioprocessing. The time for a shift to well-studied, proven in vitro cytotoxicity testing is now.
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Lessons Learned From Implementing FDA CSA Guidance
2/20/2024
Explore how some drug manufacturers are using the latest Computer Software Assurance (CSA) guidance to reduce effort and cost and the bumps you may hit along the way.
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Cleaning And Disinfection Protocols For Annex 1
2/27/2023
The new GMP regulations coming out of the European Union will have a big impact on pharmaceutical manufacturers. Learn about executing a CSS, cleaning, disinfection, and much more.
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Overcome 3 Key Challenges Facing Life Science Contract Manufacturers
6/2/2023
It has become clear that digitizing production processes is no longer optional for CMOs and CDMOs, but a necessity to keep up with the demand and competition in the pharmaceutical, biotechnology, and medical technology industries.
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The Role Of PUPSIT In A Contamination Control Strategy
7/25/2023
Here, we discuss the relationship between the CCS and PUPSIT, highlight the role of sterilizing grade filtration in the control strategy, and talk about how this can change throughout the product life cycle.
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Testing And Selecting A Detergent Cleaning System
4/26/2023
Testing and selecting an aqueous cleaning system involves a seven-step process. In this chapter of The Aqueous Cleaning Handbook, we walk through those steps to help you optimize your cleaning process.
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ICH E6(R3): Practical Steps For Implementation
12/14/2023
Watch this presentation to equip stakeholders with actionable strategies and a comprehensive understanding of the evolving clinical trial management landscape in the context of ICH guidelines.
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Implementing A Risk-Based Approach To Calibration
2/20/2024
Discover why companies may benefit from a risk-based approach to calibration, utilizing information from User Requirement Specifications and other documents created during process development.
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Regulatory Submission Crisis Rescue: When To Take Action
6/12/2023
While a few red flags are common during any submission, several occurring in concert can precipitate a submission crisis. Learn how these can be avoided in this article.
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Single-Use Strategies For Uninterrupted Microbial Monitoring
2/22/2024
Watch as Emad Albarouki, a microbiology and sterility assurance specialist at Particle Measuring Systems, discusses the best practices for using BioCapt® Single-Use in continuous microbial active air monitoring.