Contract Stability Study Management

Our business partner is able to offer contract stability study management and analytical development services.

FACILITY

• Independent building with over 15,000 square feet
• cGMP compliant analytical and microbiological laboratory
• ICH compliant stability chambers with multiple sensors for temperature and humidity monitoring
• All equipment qualified at installation as per GAMP requirements
• Independent QA set up

STABILITY STUDY MANAGEMENT

• Stability protocol preparation
• Sample storage at ICH or customer specified conditions
• Analysis of stability samples

• - Chromatographic methods
• - Spectrophotographic methods
• - Dissolution testing
• - Physico-chemical properties
• - Bio-burden testing
• - Preservative efficacy testing

ANALYTICAL METHOD DEVELOPMENT & VALIDATION
Our partner offers comprehensive services to take care of all your analytical method validation requirements.

MICROBIAL ANALYSIS
Our partner's microbiological laboratory is modern and fully equipped to perform tests to support different types of Stability programmes. The facilities are fully cGMP compliant and include a Class 100 Bio safety cabinet.

For more information please contact us >