What are the specific requirements for record-keeping in a Quality Management System? How long must records be kept?

In the pharmaceutical wholesale industry, complete records are the only way to demonstrate compliant operations and achieve product traceability. GDP requires clear, accurate and timely records of all key activities. These records must be sufficient to reconstruct the full “life history” of every batch of pharmaceutical products, from procurement, receipt, and putting into storage through storage, picking, sale and final dispatch. Records to be retained include, but are not limited to: purchase orders, invoices, receipt inspection records, inventory records, temperature and humidity monitoring records, sales orders, dispatch records, customer qualification documents, staff training records, internal audit reports, complaint handling records and recall records. All records should be kept securely and systematically and be available for inspection by the regulatory authorities at any time.