How to Prepare for a FDA Inspection

How to Prepare for a FDA Inspection

⚠️ 5 Most Common FDA 483 Observations in Pharma 1. Inadequate Investigations (OOS / Deviations / Complaints) Failure to thoroughly investigate out-of-specification (OOS) results, deviations, or complaints. Root cause analysis either incomplete, unjustified, or not...
Regulatory Expectations from Cleaning Validation

Regulatory Expectations from Cleaning Validation

Regulatory Expectations from Cleaning Validation Cleaning validation is a documented evidence-based process to demonstrate that cleaning procedures effectively and consistently remove residues of products, cleaning agents, and contaminants to predetermined acceptable...

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