Willing parties, quality agreements and information from suppliers are all needed along with auditing programs in managing pharmaceutical supply chain risks, CDER Office of Compliance Division of Manufacturing and Product Quality (DMPQ) Director Richard Friedman stressed in addressing industry/regulator initiatives to strengthen supply chain integrity.
In a Biopharm International podcast in early September, Friedman emphasized that “for risk management approaches to be successful and effective there are three very important things that have to happen: ● you have to have willing parties – the manufacturers will need to engage their suppliers early and often to express their needs ● there need to be quality agreements – contracts that are associated with that engagement, and ● manufacturers need to have access to accurate information from their suppliers to weigh the risks.”
Underscoring the importance of engagement with suppliers, the compliance official stressed that “suppliers have to be willing to cooperate. If you don’t have willing partners on both sides then you don’t have a good business relationship, and there has to be a lot of questions asked about whether or not there should be any exchange of drugs between the parties.”
In managing risk, FDA understands that qualification is not going to be at the same rigor for each supplier, Friedman explained.
“There are going to be more frequent ongoing audits of some suppliers that might not be as strong in their manufacturing ethic as one that has a long, proven track record. You might audit one manufacturer every year and another manufacturer every three years, depending on what their supply reliability quotient is. So there is that type of risk management going on in the industry already, we are hearing.”
The DMPQ director emphasized that FDA is “very much in favor” of industry’s cooperative efforts to improve quality assurance and secure the pharmaceutical ingredient supply chain such as Rx-360 and the International Pharmaceutical Excipients Auditing (IPEA) program.
[More from Friedman on supplier risk management and the role of collaborative approaches is provided for subscribers here. For further insights from the compliance official on supply chain issues and developments see the September 9 companion stories.]
Editor’s note: IPQ has been closely tracking industry and regulator supply chain initiatives since its launch in the fall of 2007. For example, the November/December 2008 IPQ Report provides an in-depth analysis of the drug supply chain problems and the industry and regulatory efforts to address them on an individual company, regional and global basis. IPQ’s May/June 2008 Report focuses on hearings in the US Congress to reevaluate FDA resourcing and authorities in the wake of the heparin problems.