
- BioPharm International-09-15-2019
- Volume 2019 eBook
- Issue 3
Why Pharmacopoeia Compliance Is Necessary (eBook)
In this series of articles, the authors provide an understanding about the need for pharmacopoeia compliance and practical guidance to assist those who perform this work.
Pharmacopoeia Compliance Series
Compliance with requirements published by pharmacopoeias around the world is a legal and regulatory requirement in those countries and regions in which the pharmacopoeia is applicable. Awareness and understanding of this need for pharmacopoeia compliance is crucial.
There is often insufficient understanding, however, by stakeholders at all levels of the need to comply with requirements in the pharmacopoeias. This situation can lead to a lack of appropriate attention and resources allocated to ensure compliance.
This series of articles were written to provide a common understanding and to detail practical ways that pharmacopoeia compliance may be addressed.
This article part of a series that will be published in 2019–2020.
Article Details
BioPharm International
eBook: Regulatory Sourcebook, September 2019
September 2019
Pages: 18–25
Citation
When referring to this article, please cite it as J.M. Wiggins and J.A. Albanese, “Why Pharmacopoeia Compliance Is Necessary," BioPharm International Regulatory Sourcebook eBook (September 2019).
Articles in this issue
about 6 years ago
Global Pharmacopoeia Standards: Why Harmonization is Needed (eBook)about 6 years ago
Why Pharmacopoeia Compliance Is Difficult (eBook)about 6 years ago
What’s New in Regulations and Complianceabout 6 years ago
Quality Culture Drives Patient Confidence in Drug Productsabout 6 years ago
Biosimilar Quality Requirementsabout 6 years ago
Is it Time to Update cGMPs?about 6 years ago
Regulatory and Standard Setting Organizationsabout 6 years ago
Resources, Guidelines, and Guidance DocumentsNewsletter
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