This Responsible Person audit checklist supports Good Distribution Practice in pharmaceutical wholesale environments. It covers agreements and reporting lines for the Responsible Person, Wholesale Dealer licence details, and technical agreements with subcontractors and carriers. Sections guide checks on vendor and customer bona fides, purchasing, sales order processing, goods receiving, order assembly and dispatch, customer returns, and handling of damages, quarantined, and recalled stock. Storage controls include cleanliness, pest control, temperature monitoring and mapping, calibrated sensors, alarms, and security. The quality system spans SOP control, training, deviations and CAPA, traceability, recalls, and counterfeit prevention.
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