Quality Assurance & Control

Above all, Quality.

The four pillars of an effective and compliant QA program are said to be Product Safety, Reproducibility, Effectiveness, and Customer Focus. At Theragent, we have built a cutting-edge quality infrastructure utilizing fully electronic systems, while instilling a culture of quality within our entire organization to ensure those four pillars are the cornerstone of everything we do.

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