![]() ![]() Once you know your requirements, identify the appropriate controls, such as:.Be sure your chemistry, manufacturing and controls (CMC) department has conducted a freeze-thaw study. Next, it’s critical to know the shipping and storage conditions of your material, as well as the acceptable temperature excursion parameters. Approved DEA Quota/DEA223 License/DEA222 for controlled substances.Challenge Your Base Assumptions Materialįirst, it’s critical to know what you are shipping for regulatory, compliance, and safety-handling purposes: Therefore, don't let anything happen by chance. One wrong move can cause disruption, and you would be accountable for any delays. What’s key to ensure is having the discipline to follow through on each step of the way, after all, your supply chain is only as strong as its weakest link. Additionally, we will also provide advice for readers on how to foolproof their logistics. Each type of shipment is a critical piece in a successful clinical trial, and each pose its own challenges, from the risks incurred in handling multimillion-dollar shipments, to frequent time-sensitive shipments.Įach challenge will be systematically broken down using the five Ws and H approach, listing critical criteria to consider, while providing actionable information for readers to achieve flawless execution. Technically, there are three types of shipment categories: bulk, site and patient (direct-to-patient), and returns. What follows in this article is a lessons learned account drawing on our personal experience working in the biotech/pharma industries for 10-plus companies. Naturally, there is no one size fits all formula/playbook, but the core guiding principles are the same. Proven success with no disruption to supply.Widely tested by various companies with differing business models, diverse sizes, and cultural environments. ![]() In our experience, three criteria, at a minimum, need to be met to achieve best practice in clinical supply logistics: ![]() Its first known use is believed to have been circa 1861 (2). According to Merriam-Webster, “oth logic and logistics ultimately derive from the Greek logos, meaning ‘reason’." But while logic derives directly from Greek, logistics took a longer route, first passing into French as ‘logistique,’ meaning ‘art of calculating,’ and then into English from there. It is important to understand the word's language(s) of origin, which could help us better understand the art of what we do. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |