184 Lessons learnt from cross contamination/gradient study across pharmaceutical formulation sites

Cross contamination in pharmaceutical industry is a serious issue which can affect the quality and safety of drugs. Methods for conducting the Cross-contamination study, identifying potential routes of contamination and results from the swab and air samples will be presented. The evaluation criteria for the cross contamination study involves calculating the potential contamination in a maximum daily dose of one product and compare it with Permissible Daily Exposure (PDE) values. Key recommendations related to management of ventilation systems and work practices to minimize the cross-contamination will be shared.