PDA TR 73-2 PDF

As a result of the COVID-19 pandemic, many industries-the pharmaceutical included-went through a substantial disruption.Some of these disruptions included facility shutdowns, unprecedented supply chain challanges, worker availabitlity, and quality system limitations (e.g. physical signatures, investigations, document originals, risk assessments, audits.) For many pharmaceutical companies, challanges increased as they raced to provide a vaccine or a therapeutic treatment for COVID-19. Their manufacturing operations were changed over to accommodate the creation of the vaccine and, in order to get the vaccine to patients quickly, many logistical challanges arose.

This document provides lessons learned from the COVID-19 pandemic to pharmaceutical manufacturing. Areas covered include manufacturing, people, quality, regulatory and supply chain.