Stability studies are a critical component of pharmaceutical drug development and regulatory compliance. These studies and testing assess how environmental factors—such as temperature, humidity, and light—affect the quality, safety, and efficacy of drug substances and formulations over time.
Conducted under predefined ICH guidelines, stability testing helps determine a product's shelf life, recommend storage conditions, and establish expiration dates. Whether for new drug applications or lifecycle management of generics, stability studies ensure that pharmaceutical products remain consistent and reliable throughout their intended use.
VerGo Pharma offers ICH-compliant stability testing services across all climatic zones, supported by robust infrastructure, data integrity systems, and regulatory expertise.
We offer comprehensive stability testing solutions as per ICH guidelines to support pharmaceutical product development and regulatory compliance. With precise tracking, data trending, and detailed reporting, we ensure your formulations meet global quality standards. Our capabilities include:
Tailored ICH stability study protocols for real-time and accelerated conditions.
Secure sample storage with full traceability and documentation.
Periodic analysis using validated analytical methods.
Statistical analysis and graphical data representation for trends.
Scientific evaluation to determine product shelf life.
Identify degradation pathways under stressed conditions.
Simulation of real-world product use conditions.
High temperature, humidity, and freeze-thaw studies for product robustness.
Detailed data and regulatory-compliant documentation.
VerGo Pharma’s stability testing is powered by advanced infrastructure and strict quality controls, ensuring precision and compliance:
1,15,875 Litres across walk-in and reach-in stability chambers.
Photostability cum humidity chambers for light exposure evaluations.
Supports semi-permeable packaging material testing.
Yokogawa DAQSTATION DX2000 ensures regulatory data integrity.
Includes power backup, overshoot protection, and PLC-based controls.
All chambers are continuously monitored using Yokogawa DAQSTATION DX2000, a US FDA 21 CFR Part 11 compliant data acquisition system ensuring data integrity, audit trails, and real-time alerts. We also have power backup, temperature overshoot safety devices, and PLC-based monitoring systems to guarantee uninterrupted performance.
Full compliance with US FDA data integrity standards.
High-accuracy sensors integrated with audit-capable software.
Dedicated in-house analytical and QC labs to support all testing.
From protocol development to regulatory-ready reports.
Capability to perform studies for all four ICH zones.
Assistance with test sample clearance and storage.
Looking for a reliable partner for ICH stability studies and stability testing services in India? Contact VerGo Pharma today for a customised quote or to schedule a facility tour.
Email: info@vergolabs.com | Phone: +91-832-6695000