The Steps Drug Makers Must Take Now To Avoid A Post-COVID-19 Manufacturing Crisis
How pharmaceutical companies should plan to catch up after the pandemic and explain what happened to inspectors.
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Guidance from the FDA urges a focus on restarting production, easing drug shortages and completing quality assurance activities for quarantined batches when the coronavirus pandemic recedes.
Focus on restarting production, easing drug shortages and completing quality assurance activities for quarantined batches, agency guidance says.
Invalidated OOS results are ‘red flags’ during FDA inspections and ‘denying, delaying, limiting or refusing’ a drug inspection proposed by the agency could have serious consequence, participants at a recent webinar on best practices for responding to Form 483s and warnings letters heard.