Module 7: Logistics

Abstract

Producing clinical trial supplies is an exceedingly complex business, especially if one considers going to clinics in a variety of countries and using short-shelflife materials. Starting with the Clinical Protocol, students will design a packaging configuration, plan the labelling/packaging, specify the necessary IPCs, and “release” the finished kits.

Objective

Preparing investigational medicinal products (IMPs) is one of the core activities for an industrial pharmacist; this involves manufacturing, control, and release activities similar to those for commercial production, but on a smaller scale and in a highly variable environment. The aim of Module 7 is to illustrate the complexity of the process from API to bed-side and how holistic thinking is needed in lieu of strict rules-based “commercial logic” to get the job done. The student should understand who is involved and what regulations need to be followed. Given a simplified Clinical Protocol, he/she is to design a patient kit and the packaging process, and assess the involved risks. The student will draft a process flow for the manufacturing and distribution of patient kits that takes into account the necessary risk-reduction mechanisms.

Content

The following areas will be touched upon: production of API & drug form, transformation of medical plan to kit design, packaging logistics, release and distribution, global operations, and outsourcing.

Resources