The USP has published draft supply chain integrity guidance outlining steps to stop counterfeit or adulterated drugs reaching patients.
Increased focus on threats to the supply chain has prompted the US Pharmacopeia (USP) to add a chapter tackling the topic to its public standards. The scope of the document was welcomed by some.
Hedley Rees, managing consultant at Biotech PharmaFlow, told in-PharmaTechnologist: “It strongly reinforces the need to include all involved in the chain of custody, especially those previously receiving scant attention, such as brokers, re-packagers, airlines, freight forwarders and even the mail.
“I am personally well aware of the comprehensive consultations and hard slog the USP Committee has been through to pen this guidance.” Rees was the moderator when Mary Foster, a USP expert committee chair, discussed the proposed chapter at an outsourcing conference in October 2011.
The USP chapter aims to cut risk at each step in the supply chain, from sourcing of raw materials through to distribution to patients, and wants manufacturers to be proactive in ensuring integrity.
“Spending time in advance to fully investigate, assess, and understand if a potential supplier is a suitable partner helps avoid problems that could arise later”, the USP wrote. Rees welcomed the chapter’s emphasis on improving “risk management, supplier relationships and quality systems”.
Building a supply chain quality system requires extra work from manufacturers. While ICH Q10 is a solid basis for product safety, the USP says supply chain integrity requires “going beyond the typical product compliance and control measures described in these quality frameworks”.
An extra step the USP recommends is forming a senior management structure focused on product safety and supply chain integrity. Companies should also define roles and responsibilities for tackling supply chain integrity risks, the USP wrote, and train staff to execute these tasks.
An evolving document
Praveen Tyle, chief science officer at USP, said the document is “an initial proposal” that will “evolve as industry, US Food and Drug Administration and others weigh in”. The USP is accepting comments until May 31 and will discuss feedback at a workshop it is holding earlier that month in Maryland, US.
Discussion about the document has already begun. Rees said the document is “an important contribution” but it still has “a gap that continues to permeate all these various guidelines”.
A mechanism for coordinated multi-stakeholder activities and decision making is still absent, Rees said, meaning pharmaceutical “supply chains disconnected like no other, both physically and emotionally”.
In-PharmaTechnologist will expand on this topic in a follow-up article.