Via additional controls for material, warehousing and distribution, drugmakers' quality systems can help bring greater security to the pharma supply chain. That's the conclusion of the ISPE's International Leadership Forum, as disclosed in a recent report.
In line with those quality systems, supply chain security will benefit from a risk-based management approach, the authors say. They examine the risk of, and risk-management approaches to, supply chain vulnerabilities. Among them are adulteration, including the deliberate substitution of a substance in a product to increase the product's market value. Other vulnerabilities include counterfeits, diverted drugs, cargo theft and geographical factors.
The authors propose programs to prevent counterfeiting, citing the need for processes to handle suspected counterfeit events. Also proposed: processes to deter the actions of those who have access to the supply chain but are external to the brand holder, the general source of counterfeits, the authors say. Recommendations include use of security features to provide a means of product authentication, and use of a counterfeiting incident management plan. Programs to prevent illegal diversion and cargo theft also are proposed.
- here's the ISPE paper