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FDA’s 2025 warning letters are out — and they send a very clear message: the agency is back in force on GMP enforcement, and the fundamentals are where firms continue to stumble. Whether your operations are sterile or non-sterile, API or finished dose, the issues that keep showing up are not random — they point […]
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How to Audit a RABS (Restricted Access Barrier Systems) isolators for GMP (Good Manufacturing Practices) involves thorough assessment to ensure compliance with regulatory requirements and industry standards. Here’s a structured approach you can follow: Pre-Audit Preparation Review Documentation: Obtain and review relevant SOPs (Standard Operating Procedures), validation documents, maintenance records, and any previous audit reports […]
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