A documented contamination control strategy is not an option; it is a requirement per GMP Annex 1 revision.
Contamination control should commence with facility design and end with product shelf life. Contamination of a product can occur due to the environment, equipment, process and/or personnel. If not thought through utilizing a good scientific rationale and properly documented; contamination control strategies can be lost in day to day operations. This half day practical workshop will teach, through case studies, how to address risk at each step of manufacturing. It will also impart strategies on how to take appropriate measures which then can be documented in the contamination control strategy.
Additionally, this policy can become a living document for proactive actions instead of reactive chaos.