Tag: Quality Systems

Investigating Backing Delamination at Accelerated Stability: A Systematic Approach Backing delamination in transdermal drug delivery systems can significantly impact product integrity, therapeutic efficacy, and regulatory compliance. When delamination occurs during…

Root Cause Analysis of Edge Lifting Following Adhesive Change in Transdermal Systems The phenomenon of edge lifting after adhesive change is a significant quality issue within transdermal drug delivery systems.…

Devising an Effective GMP Investigation for E&L Failure Following Backing Material Change In the realm of pharmaceutical manufacturing, the integrity and efficacy of transdermal drug delivery systems hinge on meticulous…

Understanding Drug Crystallization Challenges in EU/UK Market Supply: A Process Parameter Review In the pharmaceutical industry, ensuring the stability and integrity of drug products is paramount, particularly during the supply…

Investigation of E&L Failure in Lamination: A Guide for Compliance and Quality Assurance Managing Extractables and Leachables (E&L) failures during the lamination process in pharmaceutical manufacturing is critical. Such failures…

Investigating Packaging Dry-Out After an Adhesive Change: A Structured Approach In pharmaceutical manufacturing, the integrity and performance of packaging materials are critical to product quality. A recent deviation encountered during…