Supplier audits and certification
-Joe Famulare, deputy director, Office of Compliance, CDER
"There are many initiatives on the table regarding third-party certification of suppliers, including parts of the Import Safety
Action Plan and proposals on Capitol Hill," said Famulare. [The action plan calls for FDA to have the authority to require
that producers of certain high-risk products in a particular country, under an agreement with that country, certify that their
products meet FDA standards in order to export to the US.] "Other types of possible legislation changes may mandate that companies
audit their suppliers," he added. "The main effort in this area is within ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (APIs), and the voluntary standards of the International Pharmaceutical Excipients Council and International Pharmaceutical Excipients
Auditing," he said.
Table I: Supply chain changes since 2001.
In another conference session, Famulare discussed supply chain qualification. "We have a task force within CDER compliance
and there could be a guidance in that area forthcoming. We also enhanced ICH Q10: Pharmaceutical Quality System Section 2.7 regarding outsourcing to lay out a basic form of supply chain control by industry," said Famulare. "We're still
studying the lessons learned from heparin and how to prevent it from happening again, but really, industry has to have the
intelligence on their own supply chains."
External quality systems
"For external supplier quality systems, whether you contract out or are getting supply, the regulations are specific regarding
the testing to do to receive those materials and validate them," explained Famulare. "Now, with ICH Q10, having a program
to audit that system and facility supplying you is very important—it goes beyond testing.... Having the intelligence to understand
what may adversely impact that supply is also important. We don't expect the external supplier to have a mirror image of your
quality system but we do expect it to mesh...and work with your quality system."
-Deborah Autor, director, Office of Compliance, CDER
"We all share these new challenges and we all need to give serious thought to what we do.... It's not as simple as more inspections.
We need to change the system," said Autor. "The old system was directed toward a domestic industry; that's not what we have
anymore. Regulators and industry need to do more....
"We need more corporate responsibility. We're not in the shoe business. People are relying on these products to protect their
health. We need to know where a product has been, where it was made, its integrity..." and so forth, she explained. "Management
needs to be able to vouch for its products.... We can no longer say, 'FDA has to prove a drug product is bad.... We have to
know a drug is 'good.'"
Autor also talked about how industy needs to shift to international cooperation in the longterm. "The job is simply too big
for one regulator to do," she said. The European Medicines Agency/FDA joint inspection pilot is ongoing for information-sharing
on European Union and US sites, and on API sites in third countries.
Author closed with the following: "In a global economy, manufacturers must bear clear responsibility for the integrity and
quality of all ingredients. If you disagree with that, please let me know. Regulators must work together to adopt a worldwide
approach. Together, we have to ensure that drugs are what we want ourselves and our families to take and to feel good about."