Leaders in the Regulatory Management of Pharmaceutical Products, Cosmetics and Medical Devices
Requirements for certifying Good Distribution and Transportation Practices in Peru

Requirements for certifying Good Distribution and Transportation Practices in Peru

To certify Good Distribution and Transportation Practices in Peru, the following documents are
required:

– Client list
– Supplier list
– List of products being marketed
– Quality manual
– Job description manual
– Distribution service contract
– List specifying storage and packaging conditions for proper preservation during the
transportation of pharmaceutical products, medical devices, and health products
– Organizational chart
– Staff list
– Vehicle qualification/packaging qualification (as applicable)
– Calibration certificates (as applicable)
– Staff training (related to distribution and transportation) and training records
– Route planning
– Temperature monitoring records (can be from the last 3 months)
– Instructions for transportation staff
– Vehicle and equipment maintenance program and records (if applicable)
– Vehicle cleaning records (if applicable)
– Complaint and claim records (related to distribution and transportation)
– Self-inspection records
– Recall records