Considerations for performing virtual quality audits on manufacturers of gene therapy viral vectors: an auditor’s perspective during the COVID-19 public health emergency

Abstract

The capabilities of a viral vector manufacturer should be commensurate with Chemistry, Manufacturing and Control (CMC) expectations for phase-appropriate current Good Manufacturing Practices (cGMP). As a critical part of the selection process, a comprehensive quality audit should be planned and conducted. The ongoing COVID-19 pandemic has introduced challenges for an industry increasingly dependent upon Contract Development and Manufacturing Organizations (CDMOs) that produce critical ancillary materials, products, and services. These audits would include an overview of the leadership team, company stability, values and quality culture, talent pool and subject matter expertise, Quality System maturity, and Quality by Design philosophy and processes. During the COVID-19 public health emergency, where the opportunity for onsite audits is restricted, the elements of a virtual audit need to be considered and incorporated into robust audit planning and execution. The virtual audit is becoming a critical event, as IND sponsors are ultimately responsible for the quality of raw and ancillary materials, final drug product, and the safety of patients participating in gene therapy clinical investigations.