Pharmaceutical Quality Community

Hi Kim,

As you know, I am interested in participating on this team.  I will be contacting Catherine at USP this week about what we discussed.  I think there are a number of excipient topics that we might want to discuss.  One possibility might be a discussion about the new IPEC Excipient Stability Guide which highlights why excipients need to be handled differently than APIs as far as stability is concerned.  It discusses various different types of stability concerns and the type of data needed to support these different types along with information about how to establish appropriate retesting/re-evaluation periods and expiration dates.  Just a thought.  This IPEC Guide was just revised and published, so I thought it might be a good time to go over this with the community.  However, there are many other types of excipient topics that could be covered as well.

Regards,

Dave

I was thinking the same thing last weekend, so I totally agreed.

Who would be the best person to organize this? 

Who would be the best speaker for this webinar? Can you address it? 

Bests, Kim

Hi Kim,

I think that Pricilla Zawislak would be the perfect person to do this presentation/webinar since she was on the revision team for this IPEC Stability guide and she has done a number of webinars on excipient stability in the past for IPEC at various venues.  She is on vacation for the next two weeks, I believe, but I can try to contact her to see if she is interested.  I am not sure thought if she will be checking email since I think she is going to be hiking and traveling in Norway and Iceland.  However, I can certainly touch base with her when she gets back if I don't hear from her.  Let me know if you would like me to contact her.

Regards,

Dave