CLEANROOM

FDA Warning Letter: Major Sterility, CAPA, Environmental Monitoring and CGMP Violations

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FDA Warning Letter: Major Sterility, CAPA, Environmental Monitoring and CGMP Violations The FDA Warning Letter reviewed in this article identifies significant Current Good Manufacturing Practice (CGMP) deficiencies at a pharmaceutical facility involved in the manufacture of sterile injectable drug products. The inspection was conducted under the authority of the U.S. Food and Drug Administration (FDA) … Read more

AHU / CLEANROOM REQUALIFICATION

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AHU / CLEANROOM REQUALIFICATION Reference: ISO 14644-3:2019 + ISO 14644-2:2015 Objective: To verify that the AHU/cleanroom continues to maintain the required air cleanliness and environmental conditions during operation. ISO 14644-3 provides the applicable cleanroom test methods, while ISO 14644-2 establishes the monitoring/periodic-testing framework. KEY REQUALIFICATION TESTS Airflow Volume / Velocity→ Verify supply airflow and required … Read more