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

450-435-8864