News from Tunnell Consulting

It was a long, hot summer and I'm finding the cooler temps and colorful trees a welcome change. I hope that you are also enjoying the changing of the seasons.

It's still been a busy time for Tunnell and we continue to work with exciting start ups and emerging companies with so much promise in the Life Sciences industry...we never lose focus of our goal to help get medicines and treatments to so many in need.

We've also been busy writing interesting and informative thought leadership as well as attending and sponsoring events that are important to the pharmaceutical and biotech sectors.

I hope you enjoy our latest newsletter and hope you continue to stay safe and healthy.

Edgar Guerzon, a biopharmaceutical professional with 37+ years’ experience within the Manufacturing and Quality Assurance industries, has been with Tunnell for two years now. He has helped our clients with Pre-Approval Inspections, Personnel Management, Product Inspections and Audits. He is enthusiastic about mentoring and coaching our clients' employees so they can enhance their skills, continue their upward career progression and, ultimately, help patients in need.

Previously, he was a biotech and pharmaceutical consultant with Pharma Tech Services, Inc. in San Juan, PR where he was an independent consultant with major consulting firms for Biotech/ Pharmaceutical & Medical Devices. He provided services including FDA Remediation, Compliance, GMP Validation, Project Management & Lean Six Sigma. He authored and executed Validation Protocols (IQ/OQ/PQ), SOPs and reports, Global Policies and Global Procedures and Validation documents (IQ/OQ/PQ, Validation Plan and Comparability protocols) and reports for PAT (Process Analytical Technology) and assisted with the authoring of four books on FDA Warning Letters and “Conducting Compliant Investigations”. Previously he was Director, Quality Site Head at BluCaribe where he was responsible for the implementation, maintenance and continuous improvement of the Site Quality Systems to ensure the manufacturing of high-quality products, on time, at competitive prices.

While the gradual shift towards virtual operations has been slowly marching onward since the invention of the Internet, it has become much more highly focused over the past two years since the pandemic caused this move to shift into high gear. The pharmaceutical industry in particular now finds itself in the midst of a move towards virtual global pharma, with many smaller pharma companies operating on a virtual basis, outsourcing main functions ranging from manufacturing to distribution and sales, and doing so on a global basis with an increasingly large network of contract manufacturing organizations (CMOs) in the U.S., and throughout the EU and Asia as well.

As a pharmaceutical consultant, I have had the fortunate and unfortunate experiences of observing pharmaceutical process validation outcomes. In this article, I will provide insights into two recent process validation problems that could have been avoided with an enhanced developmental approach and a greater understanding of the impact of critical material attributes and the critical process parameters. Both processes were considered successfully validated and were ramped up to commercial production requirements, at which point the processes became problematic. One process issue revolved around equipment equivalency, while the second process exhibited materials and dosage strength variabilities. Each situation required unique, time-consuming, and costly interventions to achieve a process that was truly capable and in control.