Comprehensive Validation for a New Oncology Drug Manufacturing Facility
What was the challenge faced by the client?
The client was preparing to launch a new manufacturing facility designed to produce a groundbreaking oncology drug. The facility required extensive validation to ensure compliance with international regulatory standards and to optimize production efficiency.
How Zyme was able to achieve success for the client
Zyme provided a full suite of validation services, covering Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Our team worked closely with the client to meticulously plan and execute each validation phase, focusing on critical systems such as sterile filling lines, HVAC systems, and critical utilities.
Regulatory Approval:
Operational Efficiency
Reduced Time to Market
What was the positive impact?
The rigorous and efficient validation process provided by Zyme not only ensured that the new facility was fully compliant and efficient but also positioned the client to quickly deliver their new oncology drug to patients in need, enhancing their competitive edge in the market.
This case study demonstrates Zyme's ability to deliver comprehensive validation services that ensure regulatory compliance, enhance operational efficiency, and expedite market entry, making them a trusted partner in the pharmaceutical industry.
