Major Cleaning Periodic Monitoring Reduction in a Solid Dosage Pharmaceutical Plant
Martínez Zeno, Héctor
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Regulatory agencies expected that pharmaceutical industries must demonstrated with a high degree of assurance the effectiveness, consistency and reproducibility of the cleaning process in producing visually clean surfaces and reducing microbial levels, active ingredient and detergent residues to acceptable limits. Also, once the cleaning processes are validated, it is required to periodically assess to evaluate if the cleaning process maintained its validated state. An evaluation of the cleaning process for Pharmaceutical Company XYZ was performed. Using a risk based approach and groping strategies for active ingredient and equipment, the periodic monitoring exercise was reduced for more than 50%. Key Terms – Cleaning Validation, Periodic Monitoring, Risk Based Approach, Worse Case Scenario.