Area of Note Critical aspects operation General Constant supply of medicines Minimize medicines losses Constant supply assured (spoilage and expiry) Accurate inventory records Reduce theft and fraud Forecasting Transport Transport process has no conditions negative impact Appropriate transport conditions Required storage conditions maintained Temperature excursions - risk assessment Cold chain Special care taken where needed Cold chain maintained, monitored, Appropriate containers validated Packaging procedure Cooling agents used Calibrated monitoring devices Monitoring records maintained Validated process Dispatch Procedures in place procedures Special packaging requirements Authorized recipients observed needed Dispatch and transport after Follow procedures receipt of a delivery order Authorized recipients Compliance with legislation Dispatch Provide protection containers Appropriately labeled Suitable containers used Prevent theft (e.g. locked/wrapped) Dispatch Detailed records kept (e.g. date, records customer name and address; Records ensure traceability of goods product name and batch number and quantity) Products and batches traceable Discrepancies investigated Port of entry Storage conditions met Temperature-sensitive products Appropriate conditions ensured at port of Security measures (theft, fraud entry and bribery) Module VI: Re-assessment
Area of operation Note Critical aspects General Constant supply of medicines Minimize medicines losses (spoilage and expiry) Accurate inventory records Reduce theft and fraud Forecasting Constant supply assured Transport conditions Transport process has no negative impact Required storage conditions maintained Temperature excursions - risk assessment Appropriate transport conditions Cold chain Special care taken where needed Appropriate containers Packaging procedure Cooling agents used Calibrated monitoring devices Monitoring records maintained Validated process Cold chain maintained, monitored, validated Dispatch procedures Procedures in place Special packaging requirements observed needed Dispatch and transport after receipt of a delivery order Authorized recipients Compliance with legislation Authorized recipients Follow procedures Dispatch containers Provide protection Appropriately labeled Prevent theft (e.g. locked/wrapped) Suitable containers used Dispatch records Detailed records kept (e.g. date, customer name and address; product name and batch number and quantity) Products and batches traceable Discrepancies investigated Records ensure traceability of goods Port of entry Storage conditions met Temperature-sensitive products Security measures (theft, fraud and bribery) Appropriate conditions ensured at port of entry Module VI: Re-assessment
ASSESSMENTTOOL_AideMemoire.docx