USP pointed out that supply chain excellence entails minimising dangers that arise anywhere across the supply chain, from sourcing pharmaceutical raw supplies to their manufacture and distribution. The brand new standard being proposed isn't mandatory, and it is contained within the proposed USP Common Chapter <1083> Best distribution practices - supply chain integrity. The proposal is meant to serve like a central advice document outlining the important components of a simple yet effective approach.
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. 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," USP said in statement.
""There is incentive for all players in the pharmaceutical industry - large and small companies, regulators and standards-setting bodies - to come to some agreement on issues such as track and trace technology and, at the larger level, to codify what constitutes a solid, universal approach to global supply chain integrity," added Praveen Tyle, chief science officer for USP.
"USP has developed an initial proposal that we expect to evolve as industry, FDA and others weigh in. Our role as an independent body provides an opportunity to convene all these parties and advance this critical issue. While some pockets of information are available via FDA guidances, trade organizations and other sources, an overall approach is lacking. USP can move forward something more concrete than a technical report, as part of a mechanism that can be regularly updated to best meet the needs of all."
The proposed standard addresses importation, recommending importers ought to undertake to assist to stop and detect possible dangers: supply chain risk management, improvement of existing supplier partnerships and creating a supply chain quality system
Additionally, it consists of measures to counter the threat posed by counterfeit drugs and health-related gadgets and suggests measures like packaging technologies (tamper-evident styles, authentication technologies and serialisation), collectively with drug pedigrees and machine-readable information carriers.
USP also suggests measures to deal with elements that increase the danger of theft of drug goods, drug elements and health-related gadgets; safety methods, gadgets and procedures that ought to be implemented to cut back danger; and vital info to become gathered following discovery of a theft.
The issues facing the procurement function in the Pharmaceutical Industry will be addressed at the ProcureCon Pharma Conference on 28th February 2012 find out more at www.procurecon-pharma.com