GMP Stability Testing

Averica Discovery Services, Inc.

We offer a full range of stability testing and storage services to meet the performance needs of our clients.  Our stability operations include 15,000 cubic feet of walk-in/reach-in chambers/incubators at our affiliate parent company, Neopharm Labs.  The GMP facility in Montreal meets the ICH guidelines requirements for stability testing services. We also support special storage conditions customized to a client’s specific needs. A dedicated staff and specifically designed software provides total management of stability programs including timely reports, interpretations and recommendations.

Stability Services

  • Full Range of Environmental Conditions for all ICH zones
    • 25°C/60% RH (ICH zone I and II conditions)
    • 25°C/40% RH (Permeability studies)
    • 25°C/75% RH (Permeability studies)
    • 30°C/65% RH (ICH zone IV a conditions)
    • 30°C/75% RH (ICH zone IV b conditions)
    • 40°C/75% RH (Accelerated stability)
    • 2°C to 8°C (Refrigerated conditions)
    • -20°C ± 5°C (Freezing conditions)
  • Photostability (ICH Q1B, Option II)
  • Flexible incubators to perform stability studies under stress conditions (customized)
  • All chambers are fully mapped, qualified, controlled and 24/7 monitored with alarm system (21 CFR part 11 compliant)
  • Transport studies: Cycle test and Freeze/Thaw studies, including protocol and interpretation report to justify temperature excursions during transportation and warehouse storage
  • In-use stability studies to simulate patient use of drug product
  • Trend analysis by Arrhenius calculation by a validated software in order to optimize the development of product formulations
  • Stability trends to compare different packaging materials and container closure systems
  • Narcotics stability studies
  • Customized data recording and reporting, including OOT trending, available upon request
  • Storage available for short and long term durations, alone or with analyses

Regulatory & Consulting

Our team includes industry veterans with significant regulatory experience capable of assisting clients with respect to assessing requirements and developing:

  • Stability programs in accordance to ICH Q1A, WHO and other regulatory requirements
  • Regulatory compliance for Canada, US, Europe and Asian markets
  • Design of customized Global stability testing protocols to support drug registration and to satisfy all regulatory requirements as per ICH Q1A and WHO Stability guidelines
  • Matrix and bracketing designs for reduced stability testing of commercialized products as per ICH Q1D
  • Projection of shelf-life with fully validated software for world wide regulatory submissions with 95% confidence limits and ANCOVA calculations according to ICH Q1E guideline
  • Stability packages as per SUPAC to support post market changes such as manufacturing site, container/closure, and product formulation changes
  • Annual reports including tabulation of results and graphical trend analysis by a validated statistical software respecting FDA SAS program