Preprint Review Version 1 Preserved in Portico This version is not peer-reviewed

Understanding USP Chapters 661 and 671: A Comprehensive Experiments, Review and Implementation Guide

Version 1 : Received: 6 July 2024 / Approved: 8 July 2024 / Online: 8 July 2024 (08:32:13 CEST)

How to cite: JAKKAN, K.; Mopidevi, N. N. Understanding USP Chapters 661 and 671: A Comprehensive Experiments, Review and Implementation Guide. Preprints 2024, 2024070579. https://doi.org/10.20944/preprints202407.0579.v1 JAKKAN, K.; Mopidevi, N. N. Understanding USP Chapters 661 and 671: A Comprehensive Experiments, Review and Implementation Guide. Preprints 2024, 2024070579. https://doi.org/10.20944/preprints202407.0579.v1

Abstract

Pharmaceutical packaging is very crucial in as much as it plays the role of enhancing the stability, efficacy as well as safety of the produced medicine through the material used in packaging. It is important to note that cGMP Chapters 661 and 671 are focused on explaining how one should assess the quality of container materials in the sphere of pharmaceuticals. These chapters encompass a number ofmatters among them being Plastic and glass containers and performance testing; they serve as a resource that aids in assuring all standards are met with profound proficiency. Following this, the performance of two core chapters of USP known as Chapter 661 on “Containers—Glass” and Chapter 671 on “Containers—Performance Testing” will be dealt with in a step-by-step manner in the following paper while providing a comprehensive review of both at the same time. Understanding and legal obedience to these rules, as stipulated in the above-mentioned chapter, are indispensable for almost all the parties involved in the production of the drugs, together with the policies and legislation on the same. Thus, the purpose of this paper is to describe and discuss the major aspects of the understanding, application, requirements and evaluation procedures depending on the USP Chapters 661 and 671 in the sphere of the pharmaceutical market.

Keywords

USP Chapters 661; 671; Pharmaceutical packaging; Container quality; Performance testing; Regulatory compliance

Subject

Medicine and Pharmacology, Pharmacy

Comments (0)

We encourage comments and feedback from a broad range of readers. See criteria for comments and our Diversity statement.

Leave a public comment
Send a private comment to the author(s)
* All users must log in before leaving a comment
Views 0
Downloads 0
Comments 0
Metrics 0


×
Alerts
Notify me about updates to this article or when a peer-reviewed version is published.
We use cookies on our website to ensure you get the best experience.
Read more about our cookies here.