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Batch Record Review Support for COVID Vaccine Distribution

Quality Assurance
Batch Record Review
Twenty-five Batch Record Review Specialists complete three to five records a week.
The Challenge

When the global pandemic rocked the world, our client, one of the US’s top pharmaceutical and biotechnology companies, had to react quickly and make radical changes to their day-to-day operations. Although they did not have commercial production manufacturing capabilities in place, they promptly leaped into action to take the lead in developing a vaccine for COVID-19. As a result, the client has hired an incredible number of individuals to support their explosive growth — over 1,000 people in the past six months. Because we had worked with this client in other areas, they trusted Oxford Global Resources to step up and provide the necessary, hard-to-find talent to support their batch record review efforts.

The Solution

Initially, we provided three Batch Record Review Experts. As the project expanded and the volume of batches increased, so too did our support. There are currently twenty-five consultants assisting this client with Batch Record Review. Their responsibilities include the monitoring and verification of cold storage integrity, temperature mapping, safe shipping processes, drug product, plasmid, and lipid review — all critical elements to ensure the quality of the vaccine. Their dedication to the project is reflected in the hours they contribute and their high level of quality control. In addition, several individuals have taken the lead by tracking the metrics and KPIs of the group and reporting back to the necessary management.

The Result

The individual teams have been able to complete three-to-five batches per week, on average. The quality of the resources resulted in time-savings for the client – plus instilling the additional confidence that they can proceed without re-evaluating their batch records or make corrections.

The client was pleased with the level of support provided. The Associate Director of Supply Chain QA said, “On recommendation from a colleague, I engaged Oxford to assist in providing consultative support for a unique and important role requiring a breadth of experience as well as the ability to perform detailed tasks. I received several viable candidates within days, if not hours, due to the urgency Oxford’s team put to my request and had an ideal candidate working exactly when I needed the support.”