In the rapidly evolving pharma sector, few USFDA terms are crucial, especially with growing investor interest in Indian pharma. Here's a quick breakdown:
CGMP: Stands for Current Good Manufacturing Practice. It's the gold standard enforced by the FDA that every USFDA-approved facility must follow.
USFDA Inspections:
- Pre-Approval Inspection (PAI): Before approving any new drug, the FDA checks if your methods and facilities are top-notch.
- Routine Inspections: These surprise inspections happen every two years to ensure ongoing compliance.
- For-Cause Inspections: Triggered by previous or suspected violations, these are the FDA’s follow-ups.
Form 483: A list of issues found during an inspection. You get 15 days to respond and fix them.
Establishment Inspection Report (EIR): After inspection and your response, the FDA will classify your facility:
- No Action Indicated (NAI): All clear.
- Voluntary Action Indicated (VAI): Issues found, but no immediate action needed.
- Official Action Indicated (OAI): Serious problems; corrective action required.
Warning Letter: Issued if your response to an OAI is unsatisfactory. This puts a hold on new drug approvals.
Import Alert: If things are really bad, your products might be banned from entering the U.S. market until issues are resolved.
Read also:
- Pharmaceutical Terminology
- Basic Terminology in Biotechnology
- FDA Quality Audits and Critical Observations
Resource Person: Saket Yeotikar
