Janeen Skutnik on IPEC guidelines and IPEA's third-party audits
Skutnik is director of quality and regulatory policy at Pfizer (New York) and chair of the International Pharmaceutical Excipients
Council of the Americas (IPEC-Americas).
IPEC, which represents pharmaceutical manufacturers, excipient suppliers, and distributors, has been focusing on developing
voluntary guidance for excipients and white-papers for the past 15 years, all focusing on the safety and security of pharmaceutical
supply chains. We believe that to ensure the security and integrity of the pharmaceutical ingredient supply chain, we must
have a comprehensive, multifaceted, risk-based approach to this issue.
(LOGO IS COURTESY OF IPEC)
[One growing approach is] geopolitical environmental scanning, which focuses on what is going on globally from an economic
perspective, a political perspective, and [within] other industries so that we can be better prepared to look at potential
vulnerabilities. If we look at the case study of heparin, we know that heparin is (sourced) from pigs and that the majority
of the world s pig population happens to be in China. We also know that it takes about 50 million pigs to supply the US market
for a single year. Prior to the heparin incident, we had several years where the price of pigs was increasing due to demand
as well as a disease that ransacked the pig population. Had we, as industry, been more in tune to those changes—economic changes—we
may have been better able to predict potential issues.
Solely focusing on GMPs is not going to solve the [problems we face.] IPEC is working to convert our GMP and good distribution
practice (GDP) standard into ANSI standards, which would make them voluntary consensus-based standards in lieu of government-unique
standards. This way, they can serve as a tool for industry... that FDA would find acceptable.
We need to make sure we have procedures for the good distribution of excipients and how they're received. We need to make
sure that we have a periodic audit. From IPEC's perspective, it is no longer acceptable to accept your excipient suppliers
based on paper audit. Anyone can tell you anything on a piece of paper. You need to have first-hand knowledge... from either
your individual company or from a third party.
We should make sure that we're aware whether any of our contractors subcontract out work. We need to confirm that the agreed-upon
supply chain is being used. And we need to start thinking differently about how can we ensure the integrity of packaging and
seals and also work with our distributors and excipient suppliers so we know how things are supposed to be received.
A quality agreement is something that we need to think about a little bit more for excipients. Quality agreements for excipients
in the past have not been an item of focus for most pharmaceutical manufacturers. [But they provide a very] important way
to delineate what is important, what expectations [of the supplier] are, and how the two parties can work together. IPEC has
developed [free quality agreement] templates for use with excipient suppliers and distributors.
IPEC [also has] an excipient qualification guidance, which lays out what is important from the perspective of the excipient
manufacturer as well as the excipient user. It focuses on things like only using excipients from high-quality suppliers and
ensuring that you have a [comprehensive] vendor/supplier qualification program. It's no longer acceptable just to look at
a vendor qualification program for the top 10% of your suppliers.
US Food and Drug Administration responds to supply-chain security concerns and proposals.
We need to make sure that we have improved communications between users, makers, and distributors. If we, as pharmaceutical
manufacturers are more open and transparent with excipient suppliers, they can better help meet our needs.
Another piece of... supply chain security for excipients is the importance of the audit. It is critical to have audit information
for all of your excipients. And we have seen that the expectations of regulators are changing. We need to reassess our audit
programs, our priorities, and how we define risk. We may want to consider that the risk is not necessarily the highest with
the companies with the highest volume that you've been working with for 10 or 20 years. Perhaps there's a higher risk with
some of the smaller companies that you've never actually visited.
We need to rethink our audit questions as well. Inquire about your subcontractors, and make sure that your suppliers have
their own qualification systems.
International Pharmaceutical Excipients Auditing (IPEA) is one tool. A subsidiary of IPEC, its mission is to facilitate site
assessment for the qualification of excipient suppliers with [the goal of] reducing cost for makers and users. The report
provides you with the full details of an audit so, as a company, you can decide, does this meet my needs? The audits are done
[under] the GMP guide for pharmaceutical excipients developed by IPEC.
Overall, IPEC has numerous initiatives driving at excipient and pharmaceutical ingredient supply-chain security and safety.
We really are trying to work together with the key parties to ensure the safety and security of excipients.