Can you Trust Track & Trace to your Logistics Provider?
A few weeks ago our regulatory expert Piritta Maunu gave a webinar titled:
The Impact of 2015 Revisions to EU GMP Annex 15 on GDP" and received this question:
Regarding supply chain compliance, can you rely on your logistics provider (warehouse) who has a validated system to track and trace products?Thanks for any advice you can give
Great question! Yes, you can rely on the logistics provider's practices and processes so long as you have evaluated them. Specifically, their validation capabilities and the quality of their Quality Management System (QMS). Review items such as:
- QA/QC capabilities
- Quality documents
- Corrective and preventive actions
- Change management procedures
- Deviation management procedures
We audit our partners to ensure their Quality and GxP ducks are in a row. Additionally, you also need to have written agreements in place describing the duties and responsibilities of each party. (Where your responsibilities end and theirs begins.)
In essence, you must perform a risk assessment of your partners based on the risk profile of the products in question. You should work closely together with your partner to be able to assess all of the possible parameters related to the transport and storage of your products. Also – don't forget to conduct periodic reviews to assess the ongoing performance of your partners' processes. Revisiting the issue will ensure that your partners are following the agreements set out upon engaging with them (e.g. service level agreements).
Specific to your question on warehouse provides, here is a presentation slide that lists items which may be included in transportation and supply chain storage activities. The importance of each item is predicated on the product itself. And here is another slide that lists several options for driving risk assessment in supply chain applications. Each bullet that is relevant to your situation may initiate more formal risk assessment and documentation processes, but again, it all goes back to the needs of the product. Those are the real constraints on the product. Note the bullets list items to focus on.
Each bullet that is relevant to your situation may initiate more formal risk assessment and documentation processes. In sum, the regulations do provide for us to allow partners to take over regulatory management for their leg of the supply chain, so long as we have performed a meaningful audit of their operations.
Hope that my answer is helpful ☺
In case of any further questions, please email!
Regulatory Expert, Life Science
PS. GDP Documents you should probably read...see links below.