Londa Ritchey’s expertise in quality operations, oversight, and management has been integral to PharmaLex’s success. Leveraging her strong background in microbiology and biostatistics, she effectively manages operational plants, supervises global manufacturers, and navigates complex challenges, ensuring the highest standards in the pharmaceutical sector.
In an interview with Pharma Tech Outlook Europe, Londa shared her positive outlook on emerging pharmaceutical manufacturing trends and the promising uptake of rapid micro methods, enabling swift responses to challenges.
Can you provide an overview of your professional journey and current role at PharmaLex?
I've been in the pharmaceutical industry for over 30 years, specialising in sterile quality operations. My career spans oversight and hands-on experience as a quality manager in an operational plant, extending to supervising contract manufacturers.
I’ve built quality systems for facilities, held overall quality responsibilities for global operations, and conducted extensive auditing and working on sterile facilities and validation.
With a formal education in microbiology and biostatistics, I navigate investigations and analyse trends in microbial data. This extensive experience has led me to my current role at PharmaLex.
I've been with PharmaLex for over a year, actively engaged in Annex 1 gap assessments. I collaborate with multiple clients and focus on guiding them in achieving compliance with the Annex 1 assessment.
Given your extensive industry experience, how do you ensure compliance with Annex 1 for maintaining sterility and quality in pharmaceutical products?
It is crucial to address the realistic assessment of the company’s alignment with Annex 1 requirements. This involves assembling a cross-functional team to identify actual gaps.
Through various assessments, I've observed that transitional phases, where responsibilities pass between functional groups, often pose challenges due to disconnections or assumptions. A cross-functional team is best equipped to pinpoint these gaps.
Annex 1 encourages a holistic approach to contamination control, forcing companies to consider the interconnectedness of various elements. Establishing priorities and gradual, thorough work is crucial.
"Assign dedicated individuals, ideally microbiology, engineering, or facilities leaders, to take ownership. The collaboration of technical skills and a cross-functional approach strengthens the contamination control strategy."
Designating a contamination control director ensures ownership and facilitates proactive adjustments based on operational data. Additionally, comprehensive training for all levels is essential in fostering a deep understanding of contamination control and learning from past events to prevent future issues.
What other challenges are leaders encountering in achieving and maintaining compliance?
A significant challenge we encounter involves resource limitations. While Annex 1 appears to bring additional requirements, it’s my perspective that these are activities we should have been implementing earlier. It's essential to assess how Annex 1 integrates into daily operations, potentially combining tasks with ongoing quality systems.
Ageing facilities pose challenges, especially if not designed for Annex 1 standards. Adapting controls becomes crucial when separate rooms are unfeasible. Companies with older facilities often lack airlocks and require transitions. The shift from the old design of a grade-A room to the current expectation of separate closed barriers, isolators, and automation requires significant investments.
Ensuring sufficient microbiology expertise within facilities is vital to interpreting data for an effective contamination control strategy.
What technological trends do you anticipate could disrupt the pharmaceutical manufacturing and quality assurance field in the future?
The objective of Annex 1 is to achieve increased automation, separating people from the process, with sterile filling in isolators as the ultimate goal. While investing in automation is helpful, validation is equally necessary.
The evolving effectiveness of rapid micro methods enhances the ability of quality and operations teams to respond swiftly to unfavourable trends, gaining control over impacted materials faster than waiting for the normal incubation period for micro testing.
Isolators, automation, and rapid micro methods represent the industry’s forward directions, although progress may not always meet the pace needed for patients' well-being.
What advice would you offer to peers navigating changes in pharmaceutical compliance?
Given how overwhelming Annex 1 can be, I suggest recognising existing systems that can be leveraged. Many firms have conducted separate risk assessments for contamination control.
Annex 1 encourages consolidation without starting anew but to reference and keep facilities updated within a holistic framework. Designate a cross-functional team as subject matter experts for controlling contamination, responsible for consistently updating the strategy and ensuring the teams are mindful of it.
Assign dedicated individuals, ideally microbiology, engineering, or facilities leaders, to take ownership. The collaboration of technical skills and a cross-functional approach strengthens the contamination control strategy.
