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. View all articles in this series.
Read this article in Pharmaceutical Technology’s September 2019 Regulatory Sourcebook.
Article Details
Pharmaceutical Technology
eBook: Regulatory Sourcebook, September 2019
September 2019
Pages: 28–34
Citation
When referring to this article, please cite it as J.M. Wiggins and J.A. Albanese, “Why Pharmacopoeia Compliance Is Necessary," Pharmaceutical Technology Regulatory Sourcebook eBook (September 2019).
Full Tolerance Coverage Method for Assessing Uniformity of Dosage Units with Large Sample Sizes
March 10th 2025The ‘full tolerance coverage method’ is introduced as a coverage estimation approach for assessing the uniformity of dosage units from large sample sizes, ensuring that no dosage unit exceeds the specification range.
