Excipient Inspection and Standard-Setting: A New Role for a High-Level FDA Alumnus?

At the USP science meeting in Toronto, I met Janeen Skutnik of Pfizer, currently chair of IPEC Americas, and former IPEC chair, Colorcon's David Schonecker. (Also met incoming chair,  William Dale Carter of JM Huber, who will start his new role next year).

IPEC is doing some very important work, since excipients are so critical to patient health and safety...consider the fact that they are typically named in adverse patient reaction records... and their inherent variability has been keeping PAT enthusiasts busy for the past few years. (Click here for more).

Now excipient variability is becoming a factor to be reckoned with in QbD projects.  As Schonecker says, new drugs should no longer be designed assuming the use one specific pharma-grade excipient….instead, up to three different pharma grades must be considered in the design space to ensure that the resulting process will be robust enough, and the product of sufficient quality, despite variable raw materials.

Excipients fall outside of the scope of cGMP, and they are also considered commodities, so good luck trying to get manufacturers to tighten specs. And their being ISO certified is no guarantee that a manufacturer is producing pharma-grade excipients safely or properly.

IPEC has been breaking new ground in setting standards for excipient QA and QC, and has established IPEA, a third party inspectorate that can certify that manufacturers meet stringent IPEC guidelines.  The group is now working on standards with ASTM, and on a third-party inspection system that would allow companies to certify the fact that their product meets IPEC requirements and is suitable for use in pharma.  FDA is listening, and IPEC is reportedly sharing best practices with the Agency.

This idea of third party inspections could and should be transferred to contract manufactured API’s, to help catch substandard suppliers before their products actually hurt anyone.

Isn’t this whole idea really a no-brainer, given:

• Overextended FDA staff (remember that GAO report?)
• The fact that voluntary guidances (from ICH, ISO et al) are just that: voluntary and ISO does not get into depth re: GMP issues
• The news that most API manufacturing has moved or is moving offshore, especially to China and India AND very few contracting companies in pharma or beyond thoroughly audit  their offshore suppliers?

We’ll publish a brief interview with Janeen and David soon, but, in the meantime, let me have some fun and play gossip columnist for just a moment (something one can do in a blog)....they mentioned that they would soon be announcing the appointment of a very well known FDA alumnus, whom they couldn’t name, to the  IPEC  team.

Coincidentally, I heard from one well known, but elusive, FDA alumnus the very next day. Could there be a connection?  

Nah.  This would be an extreme departure, subject matter wise, for the person involved.  But then, this person had always advocated the QS 9000 model for pharma, so it's not completely out of the question 

Will keep you posted if I learn more....

AMS