The FDA Group’s CEO, Nick Capman, breaks down the FDA’s Q&A guidance on drug and biologic inspections during the pandemic, pointing out the important takeaways manufacturers should consider and prepare for. Read our blog post for a written breakdown of the key takeaways. We've also written on FDA's more recent guidance outlining its expectations for resuming normal manufacturing operations during the pandemic. Read that post here. Need expert quality system remediation assistance? Learn more and get in touch.
Resources:
- Blog Post: 7 Key Takeaways from FDA's Pandemic Inspections FAQ Guidance
- Blog Post: Key Takeaways from FDA's Guidance for Resuming Drug and Biologic Manufacturing Operations during COVID-19
- Guidance for Industry: Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers
- Guidance for Industry: Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency