The Approach
Our digitally enabled quality system reduces manual documentation work and efficiently links the laboratory, warehouse, and manufacturing suite. Even more important than technology and tools, though, is the quality culture that permeates our organization. Quality is not solely the responsibility of the QA/QC department. From supply chain to manufacturing to clinical logistics, quality is a hallmark of our work – because patients are waiting, and our goal is always right first-time and on-time.
Fully Electronic Systems
We utilize electronic platforms for our QMS, EMS, BMS, Validation and LIMS
Aligned Quality Standards
Quality standards as outlined in our QMS are aligned to phase- appropriate GMPs
Supplier Quality Management
Qualifying suppliers through robust and regular audit cycles
In-house QC Testing
In-house safety testing and analytical testing for identity, quality, purity, potency and stability
Quality Assurance and Control
In-house QA/QC services truly differentiate the Theragent experience. Further, our analytical method development capabilities are strongly linked to the QA/QC group, who ensure proper method transfer and validation. Below are some of the in-house services that we offer:
- Endotoxin, Mycoplasma, Bioburden, and Sterility testing
- Aseptic Process Simulations
- QC Sample Management using LIMS system
- Static and Dynamic Environmental Monitoring
- Trending Microbial and EM data
- Analytical Method Transfer
- Analytical Method Qualification/Validation
- In-process and final release testing
- Analytical testing for Identity, Quality, Purity, Potency, and Stability