Any body can guide me about transport validation. Curretntly every one asking about validation of transportation with different climatic condition during product transit. Is in transport validation only temperature and RH monitoring is sufficient or any other parameters monitoring required?. Which condition we should take as worst condition, how we have to prove the transport modes through various methods [ by air / sea/ road]. If it going with among these three conditions, how we validate? If it is shipping to african countries, how we monitor, pls guide me. We have to initiate transport validation for our product shipping process.
Thanks and regards
What are the critical factors affecting shelf-life/stability of the product you are transporting? They should be specified in your your product specification as a matter of course. Temperature and rh are the usual factors that you would consider for validating transport as these are the most likely to affect APIs and drug products.
It isn’t rocket science … you will just need a number of calibrated temperature/rh dataggers. Suitable types are not much bigger than a packet of cigarettes and are not that expensive - as you dont need to record temperature to umpteen decimal places at a rediculous sensitivity or accuracy levels.
However, they must have sufficient memory to record for a reasonable sampling interval (say 30 minutes) over the time period transport would take (allowing for reasonable delays at transit warehouses/airports etc.)
What you do is to pack the goods/products in their usual transit containers / boxes / pallets etc and include a number of the dataloggers in the packaging. You should include one in the centre of the load and one on (or near the outside) of the packing container.
When the product arrives at the destination, the dataloggers are unpacked and returned to you for data download and analysis. The customer/recieving party obviously must be made aware of the dataloggers so they know to return them to you!
I would also consider including shock measurement stickers (cheap) or use an accelerometer with data logger (expensive!) for validating transport of shock sensitive equipment.
Remember you will need to write a validation protocol and allow for three similar transport journeys - possibly timing them for the worst expected conditions i.e. longer jouneys at the hottest time of year.
Hope this helps!
Thanks for the detailed explonation, I need one more clarification on the transport validation. Any sample required with data loggers in the container? [To check the quality impact during transit]
Thanks in advance
As far as my experiance concerned , For Shipping/ Transporation of Vaccine material or liquid material by road , one should follow " WHO Guidelines on the International Packaging & Shipping of Vaccines WHO/IVB/05.23 (2005) and WHO GMP Requirements Part Validation WHO Geneva 1997 … this much i can share
The below clause is taken from PIC’s guideline and as per the tread the transport validation is required for API’s in special storage condition only?
For reference PIC’s guide line copied below:
“The level of information required depends upon the stability of the API considered.
Communication of the transport and storage conditions by the API manufacturer is
established according to the requirements of section 10.2. In the case of an API requiring
specific storage conditions (e.g. below 8°C), proof should be available that the required
storage and shipping conditions are maintained throughout the transport chain from the API
manufacturer to the finished product manufacturer. This may be achieved through validation
and verification (e.g. continuous temperature/humidity monitoring) where required. The API
manufacturer has responsibility for ensuring that transport and storage conditions are stated
on the product label (section 10.22) and that all parties involved in the distribution process are
informed of those requirements (section 10.23)”
Good day. I am also in need of SOP on Transport Validation (by Sea, export). I hope you can share one or a sample of it.
Thank you and regards. More Power.