Insights On Regulatory Compliance
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Elevating Quality Beyond Compliance
4/23/2024
See how one company was able to connect its quality processes, improve collaboration across business functions, and address the needs of its digitally-aware workforce.
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Microbial Challenge In-Use Studies
6/13/2024
Learn more about how a partner with expertise can help you navigate the complex landscape of microbial challenge in-use studies and ensure the highest standards of patient care.
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Pharmaceutical Solid-State Studies
4/9/2024
Solid-state characterization meticulously analyzes the physical properties of a drug in its solid form. Understand how this analysis is integrated throughout the drug development lifecycle.
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Ready-To-Use Cartridges: Ensuring Compatibility For GLP-1-Based Drugs
8/27/2024
Ready-to-use cartridges for GLP-1 applications offer safe, reliable self-administration. Discover how they can minimize complexities and better align with the stringent demands of modern pharmaceutical manufacturing.
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EU GMP Annex 1: Impact On Cleaning And Disinfection
3/30/2023
Explore the most recent rewrite of the EU Annex 1 document as well as the contamination control strategy outlined within.
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Impact Of Water Activity On The Potency, Purity And Bioavailability Of Oral Solid Dosage Products
11/21/2022
Explore laser-based headspace analysis, the impact of USP<922> Water Activity on primary packing selection, and the impact of water activity on the potency, purity, and bioavailability of OSD products.
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US GMP (21 CFR 820) Manufactured Oligos For Preclinical Research
10/18/2023
Learn why Custom cGMP Oligos should be considered to ensure oligo products meet the strict standards of MDx, LDTs, and preclinical research.
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Regulatory And Quality Consulting, Operational Readiness Services
10/5/2023
Learn how CAI aided a manufacturing company in merging food regulations with biopharmaceutical technology, allowing for the quick conversion of a small R&D facility into a GMP-compliant facility.
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ISO/DTR 14644 -21 Cleanrooms And Associated Controlled Environments
2/22/2024
Here, we review the Technical Report outlining how particle counters are used to classify and monitor cleanroom performance, ensuring it meets required standards under normal operating conditions.
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Realizing Business Benefit And Inspection Readiness With A Solid CAPA Framework
5/8/2024
Embracing proactive quality culture transforms CAPA from a routine task to a continuous improvement tool. Learn how senior management support and robust processes drive excellence.