Drugmakers increasingly face challenges in assessing whether an existing supplier contract is weak. Problems that frequently crop up are:
Loose subcontracting language: Subcontracting is a common cause of supply chain problems. Quality contracts must address this issue, either by prohibiting subcontracting or by clarifying which subcontractors a supplier may retain, how they’ll qualify and evaluate them and how they’ll manage compliance.
Also, the FDA prohibits companies that test, produce or distribute drugs from employing individuals or companies previously debarred by the agency. While rare, there are cases where debarred individuals have moved outside the U.S. to continue working in the drug or medical device industries. Because debarment is a U.S. concept, foreign suppliers unfamiliar with the concept will frequently resist certifying that they and their employees have never been debarred. Regardless, drugmakers should push for certification in negotiations with vendors.
When it comes to product quality, companies may assume their vendors never run afoul of regulators. But a sound quality agreement both anticipates this possibility and includes provisions to address it. Contracts should stipulate that companies can have input on any supplier responses to regulators that affect their products, and they should establish time frames for responses or other interactions between vendors and clients.
A supply chain “perfect storm” is brewing in Washington and around the globe. In just the past few weeks, the FDA announced an “unprecedented, even unexpected” global effort to tighten the international drug and device supply chain. And Congress moved forward on strong third-party audit requirements in its draft PDUFA bill.
The truth is you’re in for more headaches and complications. But there’s help close at hand: FDAnews’ Fourth Annual Supplier Quality Management Congress.
It’s three days and two nights of face-to-face interchange with top regulators and policymakers, industry experts, lawyers and consultants — and, not least, your fellow executives at FDA-regulated manufacturing enterprises coast to coast and around the world.
The congress is the opportunity you’ve been looking for. Register today.