Cencora PharmaLex

Eilish Kelly is a seasoned professional in the pharmaceutical industry, boasting a diverse and impressive career. Armed with degrees in Applied Chemistry and Mathematics, she started as an analytical chemist, quickly becoming adept in testing, method validation, and technology transfer. Her expertise expanded into cross-functional projects, culminating in her pivotal role in constructing a new facility and transferring cutting-edge products.

Kelly's skills flourished as she led compliance efforts, managed quality systems, and mastered facility qualification. She honed her analytical prowess and earned a master's in industrial pharmaceutical sciences, broadening her horizons to Europe. Her trajectory continued with a startup in the biological sector, where she excelled in quality management, equipment qualification, and data integrity programs. Her leadership ensured regulatory authorizations, and she spearheaded site inspection readiness. This journey culminated in her current role at PharmaLex as a Senior Manager in Quality and Compliance, a testament to her unwavering dedication to excellence and innovation in the pharmaceutical realm.

In an interview with Pharma Tech Outlook Europe magazine, Kelly shares her insights on the challenges and emerging trends in the pharmaceutical compliance industry and the experience she has gathered in the domain.

 How does the experience augment your role and responsibility at your current organization?

As a senior manager, I manage diverse client requests, spanning technical GMP project support, new facility design reviews, and international QP service leadership. I play a pivotal role in GMP project remediation and QMS implementation. My collaboration with skilled consultants and a varied client base at PharmaLex has facilitated both expertise expansion and continuous personal growth.

What strategies or tools can be implemented to enhance inspection readiness in the compliance technology domain?

The well-known challenges posed by inspections underline the need for comprehensive preparation to guarantee a seamless and efficient inspection process.Key to this, are various preparatory activities, starting with facility readiness. The importance of first impressions cannot be overstated. As an organization, the effort put into reaching your current state should be showcased at its best. Ensuring that areas inspectors will encounter are not only clean and tidy but also safe is crucial. This commitment to presentation extends beyond just inspection areas, as inspectors may explore any part of the site. A well-maintained environment automatically instils confidence in inspectors. Introducing a 5S program can further promote an organized work setting, enhancing overall efficiency.

“The well-known challenges posed by inspections underline the need for comprehensive preparation to guarantee a seamless and efficient inspection process.”

Understanding your own processes is equally vital. Familiarize yourself with the health authorities conducting the inspection. Utilize any available information, guides, or materials they offer to streamline your preparation efforts. Having primary documents ready for inspector review is paramount. Be proactive in identifying documents likely to be requested based on potential inspector needs. Consider leveraging your internal audit program to simulate inspection scenarios and ensure document preparedness.

Equipping your team is another critical aspect. Provide training to ensure all personnel can effectively engage with auditors. Incorporate inspection skills and behaviors into internal training programs. Identify subject matter experts who can confidently interact with inspectors and address concerns. Facilitate teamwork by reviewing past investigations or discrepancies and ensuring the designated individuals are well-prepared to discuss them, armed with supporting documentation.

Effective communication with inspectors is a cornerstone of success. Abide by certain golden rules, such as prompt documentation responses and transparent acknowledgment of deficiencies. Having a remediation plan ready for identified issues is essential. When providing information, focus solely on addressing the inspector's queries. Admitting gaps in knowledge and committing to finding answers demonstrates integrity. Collaborate with experts when necessary and allow pauses in conversations for inspectors to lead.

Maintaining professionalism is crucial. Always be courteous, avoiding conflicts, as inspectors process substantial amounts of information. Being patient and allowing them time to absorb and evaluate the information provided is vital.

A proactive approach involves being audit-ready at all times. Striving for consistent readiness promotes ongoing compliance, efficiency, and resource savings.

Support within the team is key. Recognize varying levels of inspection experience among team members and provide necessary guidance and assistance. Remember that achieving inspection success is a collective site-wide objective.

To deliver a comprehensive customer experience, how do you ensure a holistic approach to inspection readiness and fulfill your commitment to providing top-notch quality and compliance?

Client preparation is paramount. Engaging our inspection readiness services often immerses clients in the upcoming inspection's scope, leading to overwhelm with gaps. Our role is to offer structured preparation, guidance, and expert perspectives. We address specific challenges and provide a holistic approach to inspection readiness.

What are some of the major challenges you face when striving to deliver efficient and effective compliance technology solutions in the pharmaceutical industry, specifically in terms of inspection readiness?

The primary challenge lies in assisting clients within a short timeframe as they prepare for imminent inspections. We must comprehend their processes, procedures, gaps, and inspection scope. Drawing from my experience as a qualified person, I guide clients in focusing on crucial areas needing preparation.

A significant hurdle involves delivering compliance technology solutions that efficiently address data integrity requirements for computerized systems. Users of these systems, often lacking an IT background, must explain their functionality, controls, and data protection measures during inspections. Many clients underestimate the inspectors' focus on this aspect.

The third challenge pertains to understanding process automation, which is prevalent in manufacturing. Given the shortage of automation specialists, quality and manufacturing personnel need a comprehensive grasp of automation to elucidate processes during inspections.

Pre-inspection, companies often grapple with these challenges due to complexity, resource shortages, or overwhelming obligations. We offer expertise and guidance to support clients in overcoming these obstacles.

Can you describe how you address any identified gaps or non-compliance issues during inspections? How do you plan to use compliance technology to rectify and prevent such issues in the future?

When identifying gaps or non-compliances, it's crucial to establish a corrective and preventative action (CAPA) plan. This plan outlines steps to rectify the issue and prevent its recurrence within a specified timeframe. CAPA systems are integral to modern quality management, ensuring product and service integrity. Electronic CAPA systems, like TrackWise and Qualio, are commonly used for efficient management.

Such systems enable reporting, action planning, implementation tracking, and effectiveness assessment. Personnel involvement can be tailored to each CAPA stage, from execution to review and approval. Electronic systems facilitate non-compliance tracking, root cause analysis, and trend identification, all vital for managing gaps during inspections and enhancing inspection readiness.

From your experience, what is your advice for other senior leaders and CXOs working in the industry?

The significance of facility preparation for inspections cannot be overstated. Inspectors now prioritize engaging with involved individuals and understanding their objectives. Personnel, seen as subject matter experts, must be ready to share their knowledge, as inspectors view them as the most familiar with activities or systems. Previously, interactions mainly involved quality assurance or senior management, but inspections now encompass site-wide compliance assessment. Consequently, ensuring inspection readiness for all personnel is paramount.