Tag: ICH

Identifying Root Causes of Em Excursion in Grade A during Hold-Time Studies In pharmaceutical manufacturing, maintaining controlled environments is critical to ensuring product quality, especially in the production of parenteral…

Assessing Risk and Investigating Sterility Test Failures After Sterile Filtration Sterility test failures following sterile filtration represent a significant concern within pharmaceutical manufacturing, particularly for parenteral dosage forms. Such events…

Investigating Bioburden Spikes Pre-Filtration During Power Interruptions in Pharmaceutical Manufacturing Bioburden spikes in pharmaceutical manufacturing, particularly during the pre-filtration stage, can pose significant risks to product quality and regulatory compliance.…

Investigation of Filter Integrity Failures During Aseptic Filling: An FDA/MHRA Perspective In pharmaceutical manufacturing, particularly within parenteral dosage forms, the integrity of filters during aseptic filling processes is critical. When…

Sterility Testing Failure Investigations during Routine Environmental Monitoring Trending Sterility test failures during routine environmental monitoring (EM) can significantly disrupt pharmaceutical operations, compromising product safety and leading to regulatory scrutiny.…

Root Cause Investigation of Smoke Study Failures After Sterile Filtration In the realm of pharmaceutical manufacturing, particularly in the production of sterile injectable products, a smoke study failure post-sterile filtration…

Root Cause Mapping for Bioburden Spikes During Pre-Filtration in Hold-Time Studies In the realm of pharmaceutical manufacturing, particularly within sterile injectable production, bioburden control is critical. A bioburden spike during…

Sterility Test Failure Following Maintenance Interventions: A Comprehensive Investigation Approach In the realm of pharmaceutical manufacturing, especially for parenteral dosage forms, the integrity of sterility testing is paramount. A reported…