At the 2019 PDA Annual Meeting in San Diego, the Facilities and Engineering Interest Group explored the impact of aging facilities on
availability of medicines during an interest group meeting on March 12. Susan Schniepp, Distinguished Fellow, Regulatory Compliance
Associates, served as the main speaker along with an amazing panel that included a combined 200 years of experience: Hal Baseman, Glenn Wright, Maik Jornitz, Christopher Smalley and Shelley Preslar.
The U.S. FDA remains concerned about drug shortages. Aging facilities tie into that concern. Many recalls are due to product quality
issues linked directly to manufacturing. While many facilities have made incremental improvements, such as improved water systems
and eliminated dead lags, most have not kept up with market demands. Thus, aging facilities are a ticking time bomb for the industry.
For example, material degrades over time, making it harder to find parts. Plus, operations can be prone to unanticipated interruptions.
In 2015, PDA published an aging facilities survey that looked at facilities, processes and analytics and, in 2017, published a Points to
Consider document on the topic. Both can be purchased from the PDA Bookstore.
Following this overview, Schniepp presented a case study involving a 30-year-old facility producing small volume lyophilized parenterals
on three lines. In this situation, the project team developed a plan that targeted key issues and focused on installing barriers to protect
the product. Throughout all of this, the process itself did not change and all regulatory requirements were addressed properly. The key
takeaways from the case study are many. Always review the regulations in detail and develop a well-thought-out approach to the upgrade.
If possible, reach out to the FDA to discuss the plan. After all, FDA has been incentivized to avoid drug shortages. It would also be beneficial
to review the PDA survey and Points to Consider document.
More thorough notes are available in the interest group’s section on PDA ConnectSM.