Last week the US Pharmacopeia (USP) became the latest group to outline plans to fix the system but after ‘decades of neglect’ some think industry and regulators face a major challenge.
“Decades of supply chain neglect through drug development, cost-based, tactical outsourcing and price driven off-shoring have raised significant barriers to achieving the desire state, integrity”, Hedley Rees, managing consultant at Biotech PharmaFlow, told in-PharmaTechnologist.
The pharmaceutical industry has created supply chains that “traverse the globe, probably several times”, Rees said, and include “a plethora of suppliers, contract manufacturers… and other service providers”.
Achieving integrity across this network requires communication. “Greater clarity on the mechanism for the coordinated multi-stakeholder activities and decision-making” is needed, Rees said, and all proposals to date fail to address this issue.
The DMF dilemma
Rees cited the current drug master file (DMF) system as an example of supply chain integrity being threatened by a lack of upstream visibility. The problem, Rees said, stems from only allowing the regulator to see proposed changes for APIs (active pharmaceutical ingredients).
“So how do I, as a responsible drug product manufacturer, ensure that changes being made do not compromise the integrity of my own supply chain? The truth is, you cannot under the present system. I know this well having fallen foul of it in my own business dealings”, Rees said.
To fix the problem “sensitive discussions between regulators, API and other chemical suppliers, drug producers and those dealing with the commercial and competitive issues in the industry” are needed, Rees said.
The complexity of the supply chain has already led to problems and Rees was also critical of how companies have handled the situations. Actions by pharma firms compare unfavourably to Toyota, which took “total ownership” at an executive level when it had potential brake problems, Rees said.
“Companies experiencing supply chain issues do not appear to have stepped up to the plate in the way customers would normally expect. It is time to shine the spotlight on the ‘shrinking violets’ selling products to patients”, Rees said.