PDA/FDA Joint Regulatory Conference: Product Quality Risk in Aging Facilities

On Tuesday, Sept. 10, 2024, Nicholas Violand, director of Enterprise Regulatory Compliance at Johnson & Johnson, and Paul Palmer, managing director and pharmaceutical consultant at Paul R. Palmer Limited, gave presentations on challenges that may arise with aging pharmaceutical manufacturing facilities at the PDA/FDA Joint Regulatory Conference in Washington, DC.

Violand’s presentation focused on industry challenges for aging facilities, equipment risks, identifying such risks, and improving controls (1). He pointed out that drug shortages caused by outdated equipment and facilities are still a relevant problem, according to FDA, and that facility inspection issues are a “fast growing factor” in complete response letters for biologics license applications. Higher operating costs, risk of product rejections, and recalls for non-compliance may be associated with large, outdated facilities, according to Violand.

Some key risks involved in aging facilities that Violand pointed to are conditions such as temperature, mold, damage, and a lack of cleaning and maintenance. Damaged or deteriorating equipment may lead to quality defects, visibly unclean equipment can be difficult to validate, and poor facility design may lead to contamination, he said.

To mitigate some of these issues, Violand recommended business partnering and open lines of communication and oversight as crucial elements. He pointed to strategic planning to ensure baseline resource allocation. He also suggested internal and external site monitoring programs to identify risks involved in an aging facility.

Palmer’s presentation included two case studies involving aseptic facilities (2). He detailed environmental monitoring failures found at one of the facilities, which had recently experienced a change of ownership, that included squishy floors, mold, broken seals in windows, and a variety of other problems, including cheap fixes, during a consultation audit of the facility.

After their presentations, Violand and Palmer were joined by Sandra Boyd, drug national expert, OMPTO, ORA, FDA, for a Q&A session. The topic of limited capital was raised and what best practices can be used. Boyd said quality culture is “huge,” and it permeates throughout a company. If quality culture is good, then quality is a priority.

Violand said one should identify the problem and the risk associated with it. Most facility- and equipment-related action plans are not immediate, and one should contain the problem and then earmark it for the future to identify what can be done to fix it in the future, using metrics, etc., he said. Looking at the consequences can help decide to make an investment.

The question of FDA expectations for contract manufacturing organizations to transition to newer aseptic technologies in the future arose. Boyd commented that FDA inspectors will focus on old technologies, such as open restricted access barrier systems, instead of newer technology like isolators, which are difficult to maintain. Companies should not wait for FDA inspectors to come in and point out old technology, suggested Boyd, and she also said it’s a good idea to get an outside perspective on processes to see where things may be not ideal.

Violand cautioned that when FDA sees an open process, the inspector will spend time watching that process and will see things are outdated that may have gaps and, therefore, risk.

References

1. Violand, N. Risk Communication: Addressing Aging Facility Concerns to Ensure Sustainable Product Quality. Presentation at the PDA/FDA Joint Regulatory Conference 2024. Sept. 10, 2024.
2. Palmer, P. Aseptic Facility Communication and Assessment. Presentation at the PDA/FDA Joint Regulatory Conference 2024. Sept. 10, 2024.