Case Study Overview
Batch release time reduction in sterile injectables manufacturing is a persistent challenge for many mid-sized pharma companies. Long release timelines not only block warehouse space and tie up working capital, but also weaken client confidence and invite regulatory scrutiny. This case study shows how GMP Bridge helped a sterile injectables manufacturer in the DACH region cut release timelines by 40% through smarter CAPA, streamlined documentation, and proactive Quality leadership.
The Challenge
A mid-sized sterile injectables manufacturer in the DACH region faced chronic batch release delays, averaging 25 days per batch. This created warehouse bottlenecks, strained client relationships, and triggered financial penalties. Weak CAPA systems, complex documentation, and limited proactive involvement of Qualified Persons (QPs) were key barriers to efficiency.
