Stability Services
Neopharm offers 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 that meet the ICH guidelines requirements. 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 include:
- 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
Neopharm’s 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