Stability
Studies

Stability Studies

Accelerating your R&D by ensuring maintenance of product quality, safety, efficacy and meeting global quality guidelines (ICH Q1, CDER and WHO) throughout drug formulation

At GVK BIO, we carry stability studies for sample exposure followed by analysis for all stages of drug development. We have state-of-the art walk-in stability chamber with networked software complying with 21 CFR Part 11 requirements and emergency power backup. Stability studies governed by pre-defined and approved protocols for IND, NDA and ANDA formulations or as per ICH Q1 which are client specific requirements.

Capabilities:

  • Stability programs for registration batches under cGMP
  • Ongoing follow stability for commercial batches
  • 21 CFR Part 11 compliant and validated monitoring system
  • Comprehensive documentation to regulatory filings across globe
  • ~60,000 liters of storage space
  • Bracketing and matrixing approach as applicable

GVK BIO offers comprehensive stability study solutions for APIs and finished formulations as follows:

  • Stability studies for exploratory, preclinical materials and process validation batches
  • Post approval stability studies for follow up and on-going batches
  • In use stability studies

Salient features

  • Stability studies are conducted in strict adherence to GVK BIO’s internal standard operating procedure meeting global quality guidelines (ICH Q1, CDER and WHO)
  • Stability studies are governed by well designed, client approved stability protocols, covering all regulatory requirements of customer specific to the regulated market
  • Adherence to quality systems and dealing with non confirming results through OOT/OOS as appropriate
  • Stability data compilation and trends

Brochure

Formulation & Analytical Solutions

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Whitepaper

Developability Assessment of Small Molecules

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