This half day workshop will provide a practical approach to understanding and preventing contamination in medicinal products. Sterile, non-sterile and terminally sterilized products each have different challenges in relation to microbial and particulate contamination. If addressed upfront by exploring real world risks versus perceived risks, contamination can be prevented.
By comprehending the degree of harm contaminants can inflict upon the patient, preventive actions can be implemented at each phase of manufacturing to mitigate product contamination. Developing a holistic contamination control strategy with process knowledge is key for avoiding contamination events and dire consequences. This contamination control strategy should define risk control measures (technical and organisational) in support of quality risk management (QRM).