When conducting GDP audits, it can be helpful to work with question lists. We have compiled typical questions for ocean freight operations.
Audit Check List for Ocean Freight Operations
Below you will find some questions for ocean 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 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 a forwarder?
Is there defined process of responsibility transfer between the stakeholders in ocean freight SC process?
Are documented risk assessments performed and presented to shipper before any new route is used?
Is such risk assessment capturing all critical control of the process/route with actions proposed for risk mitigation?
Is there a procedure in place to minimize port operation times and ensure use of power supply for reefer containers?
Is this time specified for pharma shipments and documented in risk assessment for the particular route?
Is there a procedure in place for use of gensets?
Are there working instructions and trainings on handling temperature-controlled reefer containers?
Is there a procedure in place to address actions in case of delays?
Is there a procedure in place describing check while container is on the vessel?
Is there a requirement to restrict use of container reefers older than 5 years?
Is there a procedure in place for Pre-transport inspection of reefer container (dry, clean, odor free)?
Is there a check list for PTI before container is positioned for loading pharma?
Is there a procedure in place to precondition reefer container to required set point?
How is set point communicated to all involved stakeholders?
Is there an operability and reefer integrity check prior positioning container for loading pharma shipment?
Is there a procedure in place container PTI is unsatisfactory and reefer is not ready for loading?
Is there a requirement communicated to reefer owner on operability, maintenance and calibration requirements?
Is there a procedure in place to inform relevant stakeholders in case of on route deviations?
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