Title: How to establish growth promotion tests for pharmaceutical culture media

Biography:

Soria Hamdaoui has completed her Master in applied microbiology and biotechnology at the age of 24 years from Paris XI University. She has been the Microbiology and Toxicology Laboratory Manager for 10 years at Intertek Group PLC and developed in vitro testing and  microbiology testing activities in laboratories under ISO / IEC 17025 accreditation and Good Laboratory Practices. It included quality control tests on drugs (oral, topical, oral liquid dose, single use systems, etc), and packaging but also claim support testing for cosmetic formulations and cytotoxicity tests for medical devices. She is now working as a Senior Pharmaceutical Consultant to support and advise pharmaceutical and medical device industries.

Abstract

The present presentation is about growth promotion test and how it could be implemented in pharmaceutical industry. Culture media are used in most assays in a microbiology quality control laboratory, and if the media does not properly support growth, false negative results may be obtained. The presentation discusses some of the guidance documents and regulatory expectations regarding media growth promotion and provides guidance on establishing a compliant growth promotion test.