Insights On Regulatory Compliance
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Do You Have an FDA Audit Process in Place?
2/23/2023
Ease the stress of a U.S. Food and Drug Administration (FDA) visit to your facility by learning how to maintain a state of FDA audit process readiness.
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Key Benefits Of A “People In Plant” Program For The Pharma Industry
8/3/2023
Many pharmaceutical companies have embraced the concept of a “People in Plant” program. Explore the significant benefits that arise from implementing a People in Plant program in the pharma industry.
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Validated HPLC-UV Method For Quantification Of Paxalisib
1/18/2023
Examine research into the development and validation of a HPLC method for the quantitation of paxalisib in mouse plasma and its potential use for routine therapeutic drug monitoring.
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The Chemistry Of Aqueous Cleaning
4/26/2023
In this chapter of The Aqueous Cleaning Handbook, we explore the key definitions of aqueous cleaner ingredients, the types of aqueous cleaners, and the application of isoelectric points to cleaning.
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Key Cleanroom Design Considerations For Drug Manufacturing
4/18/2023
Compare and contrast the pros and cons of several cleanroom design and construction methods to determine the most suitable approach for your specific project.
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Testing Cell-Based Immunotherapeutics For Microbial Contaminants
10/23/2023
In this study, two different immune cell preparations were evaluated for their compatibility with the Milliflex® Rapid System to establish a USP and EP compliant method for rapid sterility testing.
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Over The Hurdles: Taking Psychedelics From Schedule I To Pharmacy
10/12/2023
Learn how a partner with experience in handling scheduled substances and navigating FDA and DEA regulation can help you advance toward clinical research and drug development with ease.
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Combat Major Cell And Gene Therapy Manufacturing Regulatory Obstacles
8/8/2023
As cell and gene therapies grow in the pharmaceutical industry, drug sponsors must determine how to successfully navigate evolving regulations, study design considerations, and a lack of animal models.
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5 Steps To Better Supplier Quality Audits In Drug Manufacturing
3/24/2023
Explore four legitimate reasons to conduct a supplier audit and five steps to achieve a better supplier quality audit.
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Balance cGMP And BSL-3 Regulatory Requirements
6/12/2023
Find the right solutions for your organization to comply with and maintain product quality and safety despite conflicting cGMP FDA 21 CFR Part 210 and 211 cleanroom and BMBL requirements.