Redefining Contamination Control Practices in Pharmaceutical Manufacturing
In the latest episode of the Exceeding Your Benchmark podcast, host Michelle Dawn Mooney welcomed Fred Ayers, Advisor for Sterility Assurance for Global Quality Systems at Eli Lilly. They engaged in an insightful discussion on the changes and challenges in contamination control practices in pharmaceutical manufacturing.
Embracing the Holistic Approach to Contamination Control
Ayers highlighted the ongoing transformation towards a holistic contamination control approach. This shift was largely inspired by the approval of EU Annex 1 in 2022, which underlines the necessity of a comprehensive contamination control strategy for both sterile and non-sterile products.
“The focus now isn’t just on the end-result like environmental monitoring. We must take into account all contributing factors – personnel, facility design, and facility process controls,” Ayers asserted. He went on to add that this shift signifies more of a refocusing of the contamination control measures to ensure product quality rather than an outright departure from previous practices.
The Interwoven Nature of a Contamination Control Strategy
Exploring the intricate nature of contamination control strategy, Ayers stressed the need for cross-functional involvement. Different departments, such as engineering, tech services, quality assurance, and quality control, play vital roles in the formulation and understanding of the contamination control strategy.
Amidst a plethora of data available for interpretation, Ayers cited the potential benefits of machine learning. He noted, “Rather than using traditional methods, we can harness AI technologies to analyze and identify changes in the process, helping us to synthesize and comprehend the data generated in real-time.”
Regulatory Updates and Best Practices in Contamination Control Strategy
In response to queries on best practices for implementing an effective contamination control strategy, Ayers highlighted the importance of a robust governance structure and cross-functional team involvement. The establishment and evaluation of key process indicators (KPIs) are integral for ensuring ongoing improvements in the manufacturing process.
On the topic of regulatory impact, Ayers underscored recent updates like the approval of Annex 1 and the revised document ICH Q9, which focuses on quality risk management. These updates stress the necessity of a holistic contamination control approach and continuous improvement, directing manufacturing processes towards ensuring product stability and safety.
Ayers recommended the PDA website for comprehensive information, especially citing Technical Report 90 on contamination control strategies. This report provides robust guidance on contamination control strategy elements, controls qualification, and validation, as well as monitoring. He also suggested participation in PDA Midwest events for more extensive knowledge and networking.
In conclusion, Ayers’ expertise brought valuable insights to the table on the evolution of contamination control in pharmaceutical manufacturing. His emphasis on a holistic, cross-functional approach, along with the use of AI technologies, underscored the importance of innovation and collaboration in maintaining high product quality and safety standards. As regulations and best practices continue to evolve, the industry’s commitment to continuous improvement remains paramount.