Shortages of critical raw materials and managing changes and substitutions
28th April 2022 | 10:00am EST / 7:00am PST / 3:00pm GMT / 4:00pm CET | Frances Sexton – TS/MS Bioprocess Chemist – Materials Management, Eli Lilly and Dennis Jenke, Chief Executive Scientist at Triad Scientific Solutions on Behalf of Nelson Labs |WATCH FOR FREE
Raw materials play an integral role in pharmaceutical manufacturing to support the target product profile. The availability of critical raw materials has been a recurrent theme in recent years and the recent COVID-19 pandemic has introduced additional layers of complexity in this already challenging environment. Among those COVID-19 related challenges are; a lack of real-time supply chain transparency; the need for businesses to flex with a surge in material demands; the need to manage an increase in supplier change notifications etc. The development of risk mitigation measures to circumvent raw material stock outages serves as a primary component of a robust business continuity plan.
We will outline pragmatic strategies that may serve to reduce the risk of material supply chain shortages. Such strategies are key to effective and efficient product commercialization. This case study will illustrate the value of a practical risk-based approach towards managing raw material substitutions and outline key considerations in evaluating and executing raw material substitutions and second sourcing strategies. A sample decision tree approach will be presented designed to enable right-sizing technical evaluation of raw material substitutions across both compendial and non-compendial raw materials. The appropriate application of prior knowledge in this regard will also be discussed.
Presented by Frances Sexton – TS/MS Bioprocess Chemist – Materials Management, Eli Lilly
Frances Sexton is a upstream Consultant Scientist currently working in the Materials Management group of Eli Lilly Kinsale, Ireland. Within her role Frances is the subject matter expert (SME) for raw materials, excipients, and final packaging. This expertise spans sourcing, qualification and release testing requirements for use of materials in clinical trial through to commercial drug substance manufacturing. Frances also specialises in Extractables & Leachables and elemental impurities requirements for biotechnology manufacturing. Frances holds a Master in biopharmaceuticals from the Institute of Technology, Sligo, Ireland.
A Change Control Strategy for Plastic Pharmaceutical Packaging Systems
It is not uncommon for pharmaceutical items including packaging systems, manufacturing components and medical devices to undergo changes during the market lifetime of a pharmaceutical or medical product. Change control is that process by which changes to an approved and registered pharmaceutical item are evaluated and ultimately approved or rejected. Generally speaking, this change control process manages the risk that a safe, effective, stable and compliant pharmaceutical or medical product is rendered unsafe, ineffective, unstable, or non-compliant by the change. Practically speaking, there is a great diversity of changes that can occur to an approved and registered pharmaceutical item, both in terms of magnitude and potential impact. Furthermore, it is logical that there be a correlation between the magnitude and potential impact of a change and the amount of testing required to evaluate and approve the change. Too much testing to support simple changes is inefficient while too little testing to support a more complex change is insufficient. This presentation introduces and discusses a risk-based approach to change control, wherein changes are described and ranked in the context of fixed risk dimensions and the required assessment to accept the change depends on the established risk (higher risk = more, and more rigorous, testing and evaluation). A risk evaluation matrix is proposed as a systematic and practical means of risk ranking and required assessment actions are linked with delineated risk categories.
Presented by Dennis Jenke, Chief Executive Scientist at Triad Scientific Solutions on behalf of Nelson Labs
Dr. Dennis Jenke is the Chief Executive Scientist at Triad Scientific Solutions LLC, a consulting organization that provides integrated, science-based, and practical E&L solutions to the pharmaceutical, cosmetic, food industries. Dr. Jenke retired as a Distinguished Scientist from Baxter Healthcare Corporation where, for nearly 35 years, he was responsible for developing and defending E&L tactics and strategies. He is widely published on E&L and related topics and is an active member of national and international standard setting organizations. Dr. Jenke is currently a Principal Consultant with Nelson Labs EU, where he interfaces with the Nelson Labs staff and clients to design, implement and report science-based, effective, efficient and complaint E&L studies and programs.
Sponsored by Nelson Labs
Nelson Labs, A Sotera Health company, is the leading, global provider of lab testing and expert consulting services. We perform microbiological and analytical laboratory tests across the medical device, pharmaceutical, and tissue industries. The company is regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex problems. We have over 700 scientists, technicians, and service specialists who diligently perform more than 700 rigorous tests in 13 global laboratory locations.
Based in Belgium, Nelson Labs Europe specializes in providing premium Extractables & Leachables testing services to the pharmaceutical and medical device industries. We also support pharmaceutical companies across the globe in developing worldwide compliance testing strategies to qualify container/closure applications and pharmaceutical production equipment from an Extractables & Leachables perspective.