FDA Releases New Guidance on Manufacturing Operations

Stay-at-home/Work-from-home mandates have disrupted critical manufacturing operations at pharma and biotech companies as employees are unable to get into their facilities and operate under normal procedures and guidelines.

Today, the FDA issued temporary guidance on the resumption of normal manufacturing operations during the COVID-19 health emergency. The focus on high absenteeism and how to handle modifications to manufacturing operations, as a result, calls for heavy reliance on risk management approaches in the decision process. Is your organization able to implement these risk management approaches quickly and efficiently? If your organization is reliant on SOPs and information that is decentralized, this will likely be a slow and arduous process without a strong reliance on sound scientific rationale.

QbDVision’s structured, cloud-based framework can remedy these challenges by allowing your employees to collaborate while still at home reviewing all of your product and process requirements along with the integrated risk assessments to provide solid justifications for changes to your process that can be documented in compliance with 21CFR11 for future evaluation. Learn more about our structured platform.