
- BioPharm International-12-15-2019
- Volume 2019 eBook
- Issue 5
Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions (eBook)
An effective surveillance program for monitoring the activities of pharmacopoeias around the world requires processes, people, and tools from across a company.
Pharmacopoeia Compliance Series
To maintain ongoing compliance with current pharmacopoeia requirements, bio/pharmaceutical companies must be aware of periodic updates, determine the potential impact, and implement appropriate changes to their quality and regulatory documentation, processes, and procedures. This article details the surveillance activities carried out by industry to monitor pharmacopoeia revisions so that companies can establish effective, efficient, sustainable, scalable, and successful processes to address these compliance challenges.
This article is part of a series that will be published in 2019–2020.
Article Details
BioPharm International
eBook: Regulatory Sourcebook, December 2019
December 2019
Pages: 26–39
Citation
When referring to this article, please cite it as J.M. Wiggins and J.A. Albanese, “Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions," BioPharm International
Regulatory Sourcebook eBook (December 2019).
Articles in this issue
almost 6 years ago
Revision Process for Global/National Pharmacopoeias (eBook)almost 6 years ago
Warning Letters Signal Steps to Compliancealmost 6 years ago
Lessons from FDA 483s and cGMP Inspection Dataalmost 6 years ago
Resources, Guidelines, and Guidance Documentsalmost 6 years ago
Regulatory and Standard Setting Organizationsalmost 6 years ago
Quality Risk Management Plans Create Effective Quality SystemsNewsletter
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