Risiko-Assessment in der mikrobiellen Kontrollstrategie
GMP / GLP / GCP
Abstract
Risk assessment in the microbial contamination control strategy
With the publication of the Annex 1 draft in Dec. 2017, the establishment of a contamination control strategy for sterile as well as low-bioburden processes got mandatory in Europe. It requests for quality risk management to define technical and monitoring measurements. For the establishment of the contamination control strategy and the corresponding risk assessment (RA), the application of Quality Risk Management tools like Hazard Analysis and Critical Control Points (HACCP), Preliminary/Process Hazard Analysis (PHA) and Failure Mode and Effect Analysis (FMEA) is highly recommended. The tools can be used either separately or elements of the tools can be combined. The establishment of a specific evaluation key for microbial risk is central element within the risk scoring. This identification key allows the ranking of the parameters severity, occurrence and detectability. The RA results in a qualitative or quantitative risk scoring at the respective step within the manufacturing process. This ensures product safety and the reduction of the contamination risk to an acceptable level.
 | Dr. Gerit Moser arbeitet neben ihrer universitären Forschungskarriere in der medizinischen Grundlagenforschung an der Meduni Graz auch für den industriellen, biopharmazeutischen Bereich bei VTU, Manufacturing Science and Technology. Sie ist Autorin zahlreicher wissenschaftlicher Publikationen und begehrte Vortragende auf internationalen Konferenzen. |
 | Dipl.-Ing. Birgit Krenn arbeitet und berät seit 16 Jahren Firmen in der (bio-)pharmazeutischen Industrie. Der Schwerpunkt ihrer Tätigkeit liegt dabei in der Herstellung von rekombinanten Proteinen und anderen Biologika |
