Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.
News|Articles|October 15, 2020
- Pharmaceutical Technology-10-15-2020
- Volume 2020 eBook
- Issue 3
Due Diligence Assessment of CMC Activities
Author(s)William J. Lambert
For planned acquisitions or licensing, a careful analysis of CMCl factors is vital to ensure no problem areas are overlooked.
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Developing comprehensive chemistry, manufacturing, and controls programs are crucial to the success of a drug product. For planned acquisitions or licensing, a careful analysis of these critical factors is vital to ensure no problem areas are overlooked. Strategies for carrying out an effective due diligence exercise are described.
Article Details
Pharmaceutical Technology
eBook: Regulatory Sourcebook
October 2020
Pages: 26–28
Citation
When referring to this article, please cite it as W. Lambert, “Due Diligence Assessment of CMC Activities," Pharmaceutical Technology Regulatory Sourcebook eBook (October 2020).
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Do Pharmacopoeias Inadvertently Facilitate Data Integrity Violations?almost 6 years ago
Tackling Cybersecurity Challenges in Legacy Systemsalmost 6 years ago
Ending ‘Magical Thinking’ in Compoundingalmost 6 years ago
Viral Vector API Characterization of Product-Related Impuritiesalmost 6 years ago
Strong Quality Culture: A How-To for Busy Managersalmost 6 years ago
Resources, Guidelines, and Guidance Documentsalmost 6 years ago
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