Isken, Jennifer and Koelbert, Celine (2025) Guidance for Auditing Sterility Testing Laboratories. Guidance for Auditing Sterility Testing Laboratories.

Abstract

This document provides some general guidance/tips and tricks for auditing sterility testing laboratories, emphasising the importance of microbiological release testing for parenteral drug products. It outlines critical elements for ensuring compliance with pharmacopoeial requirements and the integrity of sterility testing processes. There is no Novartis specific business processes or IP/product/project information mentioned in this article.

Item Type:	Article
Date Deposited:	24 Jun 2025 00:46
Last Modified:	24 Jun 2025 00:46
URI:	https://oak.novartis.com/id/eprint/57333