FDA Commissioner Hamburg has created a new FDA enforcement directorate, the Office of Global Regulatory Operations and Policy, under Deb Autor. The goal is to strengthen FDA oversight and enforcement of global supplier controls regardless of whether the product in question is a medical device, diagnostic equipment, drug, biologic, or nutritional supplement. As Hamburg noted in her announcement letter, "We have seen the dramatic transformation of globalization – more products, more countries, more access by consumers and companies to global supplies – and this presents an enormous challenge to FDA in ensuring the safety and quality of the products we regulate. In an ever more complex world, products and services do not fit into a single category [such as a drug or a device]."
This dovetails with what I wrote two years ago in Get to Market Now! Turn FDA Compliance in a Competitive Edge:
There should be little doubt that FDA regulations governing pharmaceuticals and biologics will look increasingly like the regulations governing medical devices and diagnostics, with an emphais on risk-based controls, quality by design, and international cooperation. ... For the drug, biologic, or device executive, experience with FDA regulations is no longer enough. ...traditional approaches to compliance-related issues, from FDA enforcement responses to the submission of applications to market a new drug or device, are increasingly out of date. Executives who fail to adapt their 20th century philosophies to the new realities of the 21st century regulatory landscape will find the odds increasingly stacked against them (excerpted from pp. 26-29).
So what will this new FDA office look at when it comes to international supply chain enforcement in the 21st century?
According to Hamburg, the new directorate has "A mandate from me to make response to the challenges of globalization and import safety a top priority in the years to come." Well, what does that mean in the day-to-day faced by industry?
Clues can be found in the regulatory harmonized GHTF guidance, Audits of Manufacturer Control of Suppliers. As I wrote in a regulatory analysis article, "FDA Inspectors, the GHTF & Supplier Controls," in the SmarterCompliance newsletter last year:
Firms that outsource to a CRO or a CMO should plan for the FDA inspector to spend his/her primary efforts on scrutinizing the firm's supplier selection, evaluation, qualificaiton and oversight processes.
Specifically, as part of global supplier oversight, FDA will look at how a firm conducts:
- supplier management, oversight and re-evaluation
- supplier selection and qualfication
- change management of materials and suppliers
- risk evaluation and mitigation associated with materials and suppliers
- incoming materials inspections
- corrective and preventative actions associated with materials and suppliers
- supplier audits - both internal suppliers (i.e., subsidiaries) and external suppliers
- internal quality audits and follow-up actions
Add to this the recently released draft of an ICH guideline on quality system expectations for suppliers of drug ingredients, ICH Q11 Development and Manufacture of Drug Substances, and the FDA's new membership in PIC/S, and we can easily foresee a heightened level of scrutiny on industry's qualification and oversight of their global supply chains over at least the next two years.
Next week, I'm presenting a teleconference on how to take advantage of FDA, GHTF, ICH, and PIC/S documents for inspectors to strengthen and streamline your global supplier management processes. I'll be reviewing in detail:
- critical FDA requirements and expectations
- recent FDA supplier oversight enforcement actions
- a six-step supplier qualification and oversight process compliant with FDA, GHTF, ICH and ISO
- additional lean compliance aspects to consider
And, of course, throughout the teleconference, lots of practical tips and lessons-learned suggestions. Attendees at the live teleconference will also receive 18 different inspector training documents with questions and points of inspector interest that can easily be adapted into your quality system's internal audits and supplier qualification audits. Learn more and register online at: FX Teleconferences.