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|March 15, 2020
- Pharmaceutical Technology-03-15-2020
- Volume 2020 eBook
- Issue 1
Monograph Development: Why and When to Participate (eBook)
Author(s)J. Mark Wiggins, Joseph A. Albanese
Monographs are developed based on the submission of information and materials from a company having regulatory approval for the product, and this submission feeds into the pharmacopoeia revision process.
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Pharmacopoeia Compliance Series
This article explores another proactive advocacy approach that a bio/pharmaceutical company may take through participation in the development of new and revised monographs in the various pharmacopoeias.
This article is part of a series that will be published in 2019–2020.
Article Details
Pharmaceutical Technology
eBook: Regulatory Sourcebook, March 2020
March 2020
Pages: 14–23
Citation
When referring to this article, please cite it as J.M. Wiggins and J.A. Albanese, “Monograph Development: Why and When to Participate," Pharmaceutical Technology Regulatory Sourcebook eBook (March 2020).
Articles in this issue
over 6 years ago
Resources, Guidelines, and Guidance Documentsover 6 years ago
Regulatory and Standard Setting Organizationsover 6 years ago
A ‘New Normal’ for Quality?over 6 years ago
A Practical Approach to Pharmacopoeia Compliance (eBook)over 6 years ago
Inside FDA’s New Gene and Cell Therapy Guidancesover 6 years ago
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