Microbiology: In-Depth Focus 2014

• How to deal with non-sterile results in aseptic processing
  Dr. Guenther Gapp, Gapp Quality GmbH
  Non-sterile results in sterility testing (ST) and/or media fills (MFs) represent one of the most serious challenges for quality assurance (QA) microbiologists in the pharmaceutical industry. Investigation of the root cause, analysis of the risks to the product and determination of corrective and preventative actions (CAPA) take days, sometimes weeks, of manpower and resources. Decisions are taken under enormous pressure since they are always timecritical and have a huge impact on both the patient and the company. Therefore, it is essential to be well prepared in order to manage the investigation process proactively or, ideally, to prevent forthcoming non-sterile results.
  
• Risk Profiling and Proactive Response (RPPR) to Bio-contamination in GMP classified and controlled areas
  James L. Drinkwater, Chairman of Pharmaceutical and Healthcare Sciences Society and Leader of a PHSS Bio-contamination Special Interest Group
  This paper introduces an initiative based on microbiological risk profiling and a proactive response to biocontamination risk escalation in classified and controlled environments. The concept is included in the PHSS Bio-contamination monograph 20. The monograph considers four principle requirements of a systematic approach to bio-contamination risk management and a microbial control strategy with guidance on best practice; risk profiling is one key area where a systematic approach could yield significant benefits.
  
• Microbiology Roundtable
  Moderated by Radhakrishna S. Tirumalai, Principal Scientific Liaison, U.S. Pharmacopeial Convention