When conducting GDP audits, it can be helpful to work with question lists. We have compiled typical questions for road transport operations.
Audit Check List for Road Transport Operations
Below you will find some questions for road transport 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.
Are procedures in place to transfer customer requirements (temperature range, set point) into specific activities?
Does your procedure includes instructions for different types of temperature sensitive products (like +2 °C to +8 °C and +15 °C to +25 °C)?
Are temperature conditions monitored during transport?
All vehicles intended for transport of medicinal products can print a temperature report in table format (not chart format) at a minimum interval of every 10-15 minutes per hour?
Is there an alarm in the cabin which alerts the driver on temperature different from the set point?
Is there a procedure in place for recording, handling and investigating temperature excursion?
Are security seals or safety locks used to secure the cargo?
If used, are seals number recorded, documented on shipping documents?
Is there a procedure in place regulating ordering, stock control and dispositioning of seals?
Are truck drivers authorized to replace a seal and is there a procedure to describes role, responsibilities, recording of seals and stock control management?
Is global positioning system (GPS) in use to track the delivery?
Are security and notification procedures in place in the event of product diversion or theft?
Is there a procedure in place to instruct drivers to use only secured parking facilities?
Are distribution records (temperature printout, CMR) kept for each shipment and for defined period of time?
Is there a procedure in place to supervise loading and offloading process?
For bi-temperature trailer modes are defined requirements followed to ensure no temperature excursions?
Are vehicles used for pharma dedicated to this service? If not, is there a risk assessment and specific cleaning and sanitation procedure in place?
Is there temperature mapping report for summer and winter on representative unit model?
Is there a procedure in place for regular and preventive maintenance program?
Is there procedure in place for calibration? Are calibration tolerances defined in accordance with regulations and documented in SLA?
Are records of cleaning, maintenance and calibration kept on file?
Is there a procedure in place to define frequency of maintenance and calibration? Is there SLA in place for this subcontracted services?
Is there a procedure in place in case of failure in maintenance check or calibration? Are there records of CAPA for such deviations?
Is there a pre-trip inspection on units prior loading pharma shipments (odor free, clean, dry, operable and preconditioned)?
Is there a BCM procedure for on route maintenance or incidents handling?
Is there a procedure in place for temperature alarm with escalation process?
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