Tag: Quality Systems

Dissolution Failures in Tech Transfer: Documenting for FDA and EMA Compliance Pharmaceutical companies frequently encounter challenges during the tech transfer process, particularly when it comes to ensuring consistent dissolution profiles…

Addressing Oot Dissolution Trends During Tech Transfer: Investigative Steps for Compliance In the pharmaceutical manufacturing sector, tech transfers can significantly impact product quality and operational efficiency. One common issue that…

Root Cause Analysis and CAPA Evidence for Blend Segregation during CPV Review Blend segregation in pharmaceutical manufacturing can lead to significant quality concerns, especially during Continued Process Verification (CPV) reviews.…

Investigative Steps for Hardness Drift Following Maintenance in Pharmaceutical Manufacturing In the highly regulated environment of pharmaceutical manufacturing, the integrity of product quality must be uncompromising. Hardness drift after maintenance…

Addressing Friability Failures in High-Speed Runs: A Comprehensive Investigation Guide In pharmaceutical manufacturing, friability failures represent a significant quality concern, particularly during high-speed runs of solid oral dosage forms such…

Root Cause Analysis for Content Uniformity OOS During CPV Review In pharmaceutical manufacturing, content uniformity is a critical quality attribute, especially during commercial product verification (CPV) reviews. An Out of…

Steps to Investigate Tablet Lamination Issues Post-Maintenance in GMP Environment Pharmaceutical manufacturing is a highly regulated area, with small deviations potentially leading to significant compliance issues or product failures. One…

Investigating Sticking and Picking Issues Following an Excipient Change Sticking and picking are common challenges encountered in pharmaceutical manufacturing, particularly after an excipient change. These issues can lead to significant…

Addressing the Challenges of Sticking and Picking During Compression: A Structured Approach to OOS Investigation Sticking and picking during tablet compression remains a persistent challenge in pharmaceutical manufacturing, often leading…

Troubleshooting Friability Failures During Technical Transfer: Insights on Tooling, Granulation, and Lubrication In the realm of pharmaceutical manufacturing, friability failures during technical transfer can pose significant challenges. When tablet formulations…

Addressing Friability Failures during CPV Review: Troubleshooting Tooling, Granulation, and Lubrication Issues Friability failure during a Continuous Process Verification (CPV) review can significantly impact batch quality and regulatory compliance in…

Steps for Investigating Disintegration Failure Post Scale-Up in Pharmaceutical Manufacturing Disintegration failures following scale-up present critical challenges for pharmaceutical manufacturers. Such failures often lead to out-of-specification (OOS) test results, delays…