Why a closed-loop supply chain system?
Answer: to improve compliance and efficiency in the pharmaceutical supply chain with reduced cost and risk.
The International Conference on Harmonization’s (ICH) Topic E6 entitled “Good Clinical Practice: Consolidated Guidance” is a commonly referenced industry document that has gained regulatory acceptance. Section 5.14.3 states that:
“the sponsor should ensure that written procedures include instructions that the investigator/institution should follow for the handling and storage of investigational product(s) for the trial and documentation thereof. The procedure should address adequate and safe receipt, handling, storage, dispensing, retrieval of unused product from subjects, and return of unused investigational product(s)”.
This regulation is aimed at enhancing GCP at the investigator level, despite the fact that most of the following functions are run by third parties: transport, storage and delivery. Because if this third party involvement, there is potential that these functions are being undertaken by those untrained in pharmaceutical standards. Arguably, some IMP travel thousands of miles to emerging nations (where 40% of all clinical trials take place) in the hands of non-pharmaceutical personnel before arriving at an individual research site.
How does the sponsor ensure that product transfer conforms to the same established written procedures demanded at the investigator level throughout the full length of the supply chain, or more specifically while in the hands of non-pharmaceutical, non-investigator personnel?