CAPA Effectiveness

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

FDA Warning Letter: Major Data Integrity, Aseptic Processing and CGMP Violations at Reliance Life Sciences

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FDA Warning Letter: Major Data Integrity, Aseptic Processing and CGMP Violations at Reliance Life Sciences The FDA Warning Letter concerning Reliance Life Sciences Private Limited, Navi Mumbai, India, highlights serious deficiencies in Current Good Manufacturing Practice (CGMP) compliance, laboratory data integrity, microbiological testing, aseptic processing, cleaning and maintenance, quality-unit oversight, and contamination control. The inspection … Read more

CAPA Effectiveness in the Pharma Industry

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CAPA Effectiveness in the Pharma Industry Repeated Environmental Monitoring Excursions Scenario: During routine environmental monitoring of a Grade C manufacturing area, repeated excursions in microbial counts are observed at a specific monitoring location. Initial Observation – Over three months: Multiple microbial excursions occurred at the same location. Initial investigations focused primarily on cleaning and operator practices. … Read more