Establishing Microbial QC Programs for Compounding Pharmacies

Apr 18 2013

A Microbial Quality Control Program should be designed to provide reliable and comprehensive information on the status of environmental production, demonstrate thorough metrics on the state of control of the facility and ensure effectiveness and safety of the products manufactured. This webinar discusses the global regulatory requirements for Sterile Compounding Pharmacies (SCP), global differences with respect to Environmental Monitoring (EM), the importance of establishing a microbial identification program and Bacterial Endotoxin Testing (BET) and calculation of endotoxin limits to ensure product safety.

Presenters

• Christine Farrance, PhD, R&D Director
• James F. Cooper, PharmD, Consultant
• Ulrich K. Herber, PhD, Senior Product Manager