Why Is Pharmaceutical Transportation A Major Concern?
A drug can take a variety of paths from the manufacturer to the patient. Most often, the product leaves the manufacturer’s direct control and enters a complex system of handoffs (see chart from US Pharmacopoeia). Distribution systems that deliver pharmaceutical products require special handling based on the conditions clearly indicated in the labeling for the product. The Prescription Drug Marketing Act of 1987 and the ensuing regulations in 21 CFR Part 203, Prescription Drug Marketing, and Part 205, Guidelines for State Licensing of Wholesale Prescription Drug Distributors, provide the necessary regulations and guidance for several legs of the distribution chain for the prescription drug.
Manufacturers are obligated to include distribution as part of their overall quality system and should be continuously monitored and updated to adhere to industry best practices. Current Good Distribution Practices (cGDPs) for the pharmaceutical supply chain have been divided into seven different categories (Stability, Distribution Control Management, Performance Management, Supply Chain Partner Management, Qualification / Validation, Continuous Improvement, and Import / Export Compliance) in PDA Technical Report #52.