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?
Today's marketplace offers many options for clinical trial transportation and logistics. A single GxP-compliant supplier with a proprietary closed-loop clinical supply chain system â one that incorporates packaging, transportation, warehousing, customs brokerage support, logistics management, temperature-controlled management, documentation and centralized record-keeping â offers, the most straightforward solution for sponsors striving to consistently reduce risk and meet budgetary, regulatory and performance objectives.
Is the answer a closed-loop supply chain system? Why not download the white paper and tell us what you think below!
The BioPharma Nordic Convention is pleased to announce that World Courier, the author of this white paper, is sponsoring the 2012 event. BioPharma Nordic convention is a great new event for 2012. As the regions dedicated strategic, business and corporate development congress for pharma, biotech, investors and solutions providers, this congress is a hotbed for biotechnology partnering and licensing opportunities.
In the area of clinical trials, WORLD COURIER delivers unprecedented expertise in the handling, transport, storage and distribution of temperature-sensitive pharmaceutical products and biological specimens for one-stop global clinical supply support.
WORLD COURIER's fully-integrated GxP-compliant pharmaceutical supply chain system features a company-owned network of over 150 transport offices in more than 50 countries with GMP-compliant investigational drug storage depots in 13 strategic and emerging markets, strong knowledge of the local regulatory environment, and well-trained staff who operate according to global SOPs.