Why Pharmacopoeia Compliance Is Difficult (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
For the bio/pharmaceutical industry, 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.
This article provides a comprehensive, end-to-end framework to help companies involved in the development, manufacture, and distribution of small-molecule drug products, biotherapeutic products, and vaccines-as well as the drug substances and excipients used in these products-to better understand the external and internal challenges that make pharmacopoeia compliance difficult.
This article is 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: 36–42
Citation
When referring to this article, please cite it as J.M. Wiggins and J.A. Albanese, “Why Pharmacopoeia Compliance Is Difficult," 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.
