USP takes aim at supply chain security for medicines
pharmafile | January 10, 2012 | News story | Manufacturing and Production |Â Â US Pharmacopoeial Convention, USP, supply chainsÂ
The US Pharmacopoeial Convention (USP) has published the draft of a new general chapter designed to lay out best practices for defending pharmaceutical supply chains from adulteration, counterfeiting, diversion and theft.
The new document – available here – has been released for comment by May 31, 2012, and will be debated at a USP workshop earlier that month on supply chain integrity.
The overall aim is to develop a unified set of best practices that can be used by pharmaceutical and medical device manufacturers, as well as suppliers of raw materials and other stakeholders, to develop a risk-based approach to supply chain management.
Among the topics covered in the chapter is importation of medicines, raw materials and drug components, with the USP recommending that importers develop a risk-based approach to supply chain management, backed by supplier partnerships and contracts and a robust quality system to monitor the integrity of the system.
It also covers best practices for combating counterfeit drugs and medical devices, including the use of packaging technologies, the establishment of drug pedigrees and unique identifiers for individual medicine packs.
Companies should establish a formal process for implementing and modifying security features on medicines and make sure they can authenticate their products, it says.
A range of measures to prevent diversion and theft of medicines and medical devices are proposed, including technological elements such as tamper-evident seals, immobilisation systems and tracking devices for shipments, but also procedural elements to ensure rapid response to incidents and notification of the authorities.
“While individual pharmaceutical companies have their own approaches to addressing this issue, the size and sophistication of companies and their suppliers vary widely, as do their quality systems and risk management approaches,” said USP in a statement.
“Broad consensus around issues such as track-and-trace technology does not exist, and smaller companies that may be relied upon for sourcing pharmaceutical ingredients may or may not have security approaches comparable to their larger counterparts,” it added.
Phil Taylor
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