On Sept. 13, PDA’s Facilities and Engineering Interest Group convened on the second day of the 2016 PDA/FDA Joint Regulatory Conference.
Following a review of interest group business, group members came together in a large circle to participate in the interest group’s
first speed dating session. Originally developed for the Inspection Trends Interest Group, this exercise involves participants spending five
to ten minutes on “dates” with topics of interest in the industry. During these “dates,” participants discuss the topic and make recommendations
until it is time to rotate to a new topic.
Stephen Roenninger, Director, International Quality External Affairs, Amgen, led the group discussion on health-based limits for
dedicated facilities. Speed daters discussed the EMA’s recent guideline on this topic. Overall, speed daters felt that the values behind the
cleaning limits for these facilities should be risk-based and draw from normal production experiences.
Speed daters also met with Christopher Smalley, PhD, to discuss the Quality Risk Management (QRM) process for aging facilities.
What is the key to QRM success? The group consensus is that it is critical to understand the process through an assessment, and then
evaluate if the cost of the replacement overrides the cost benefit. Ultimately, the overall ROI needs to be evaluated.
Ravi Samavedam, General Manager, Azzur Group, led the group conversation on implementation of phase-appropriate GMPs. Here,
discussions explored different requirements for Phase I products, ICH Q7: Good Manufacturing Practice for Active Pharmaceutical Ingredients,
Quality Control, and audits of raw material vendors, to name a few.
In the final group, Laurie Norwood from the U.S. FDA covered Agency-related topics. Here, daters came to the consensus that while
change can be hard, with many initial drawbacks (temporary slowdowns, “if it ain’t broke, don’t fix it” attitude, etc.), it is necessary.
Daters left this round understanding that open communication with FDA about facility upgrades and improvements can only help as the Agency really does want the industry
While speed-daters may not have found
a “perfect match” in their dates, all in all,
the discussions during the exercise showed
that interest group members remain committed
to finding solutions to the issues
affecting manufacturing facilities.