When conducting GDP audits, it can be helpful to work with question lists. We have compiled typical questions for air freight operations.
Audit Check List for Air Freight Operations
Below you will find some questions for air freight operations. Please note that these are only suggestions and the list may be incomplete. Depending on the organization specific role and scope of business, the list may need to be expanded.
Is there a procedure in place to describe shipment integrity verification (complete documents, pieces accountable, no damage, preconditioned)?
Is this process described in pharma shipment acceptance procedure?
Is there a procedure in place related to use and verification of seals?
Is there a procedure in place to minimize time and temperature abuse during screening (security) checks?
Is there a procedure in place describing loading and offloading process with risk assessment on time and temperature abuse?
Is there a procedure in place to ensure temperature requirements for pharma shipments are transferred correctly to booking with the airline?
Is there a defined process of responsibility transfer between the stakeholders in airfreight SC process?
Are documented risk assessments performed and presented to shipper before any new route or equipment is used?
Is such risk assessment capturing all critical control of the process/route with actions proposed for risk mitigation?
Are handling and manipulation areas for pharma shipment all temperature-controlled? If not is there a documented risk assessment on time and temperature abuse on each critical control point?
Are temperature-controlled premises available and in use on route?
Do those correspond to the temperature range required?
Are temperature-controlled storage areas regularly maintained as per user specification or SLA?
Are temperature-controlled storage premises regularly cleaned as per SOP or SLA?
Are temperature-controlled storage premises regular calibrated? Is there an SLA defining frequency and calibration tolerances?
Is there a business contingency plan in case of lack or malfunctioning of temperature-controlled storage premises?
Are airport loading and offloading ramps protected from environmental conditions? Is there a risk assessment on this?
Is there a qualification process in place for temperature-controlled vehicles, equipment and storage premises?
Is there a procedure in place for use of passive and active shipping systems?
Are there working instructions and trainings on handling passive and active shipping systems?
Is there a procedure in place to address actions in case of delay or flight cancelations?
Is there a procedure in place for contamination prevention during co-loading or costorage with other temperature sensitive payloads?
Is there a process in place to ensure sufficient quantity of cooling material and batteries (as applicable) on the route?
Is there a risk assessment describing aircraft temperature-controlled capabilities? Is this part of documented route risk assessment?
Is the pre-carriage and on-carriage (multimodal) performed with temperature-controlled and qualified vehicles?
Are the vendors used for pre-carriage and on-carriage approved and listed on approved subcontractor list?
Is there a time measured or otherwise controlled on each process step that is performed under environmental or ambient (non temperature-controlled) conditions?
Is there a documented risk assessment on time during which pharma shipment is under non temperature-controlled conditions such as acceptance area, ready for carriage area or airport tarmac?
Is there a risk assessment on time and temperature abuse for pharma shipment during loading and offloading of an aircraft?
Is transportation from temperature-controlled storage to aircraft done in a timely manner, providing additional weather conditions protection when needed? Is there a risk assessment on this process?
Is there a risk assessment on use of subcontractors?
Are subcontractors used based on availability of specific pharma handling and transport process?
Are documents related to transport stored for a predefined time?
Audit Check List for Air, Road and Ocean
The questions above are an excerpt from an audit check list for air, road and ocean. The document was developed by Dr Zvonimir Majic from Teva Pharmaceutical Industries Ltd. All participants of the ECA Academy Live Online Training "GDP Audits - How to Audit Logistics Service Providers" will exclusively receive the complete document, which covers the following topics:
Quality and Risk Management System - 1. Documentation - 2. Subcontracting - 3. Training - 4. Operations