Inspection

Understanding FDA’s Post-Inspection Meetings | OAI vs. VAI Outcomes

Understanding FDA’s Post-Inspection Meetings | OAI vs. VAI Outcomes

OAI (Official Action Indicated) classification: the facility is deemed out of compliance with CGMP. OAI regulatory meeting is conducted if FDA have already issued a warning letter. To DISCUSS THE ISSUES WITH THE FIRM BEFORE PURSUING LEGAL ACTION THROUGH THE DEPARTMENT OF JUSTICE. These meetings provide a deeper dive into technical matters that may require…

Audit and Inspection Readiness in Pharmaceutical Industry
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Audit and Inspection Readiness in Pharmaceutical Industry

As a life science sector audit and inspection are common terms in pharmaceutical industry. Here we going to mention a list of criteria of maintaining audit and inspection readiness at all times in pharma industry.   1. Clear Communication Channel Manufacturing and quality teams should establish clear communication channels. Regular meetings and discussions enable both…