Formal Stability Studies

Stability Protocol Design & Testing

IriSys provides stability protocol design and testing for bulk drug substances and drug products according to ICH Guidelines Q1A and Q1B. ICH guidelines are a comprehensive set of safety guidelines adopted by The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. The Quality Control laboratory generates stability data and prepares reports appropriate for submission of the Chemistry, Manufacturing and Controls (CMC) section of the Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA).

IriSys’ controlled environmental and photostability chambers are alarm-monitored and connected to a backup power source, as required. The environmental chambers are controlled at conditions defined by ICH Guidelines Q1A, which are 40º C/75% RH, 30º C/65% RH, 25º C/60 % RH, 2-8º C, and -20º C.

IriSys provides the following stability study activities:

• Protocol design according to ICH Guidelines
• Accelerated and real-time stability study testing
• Phase I and Phase II formal stability study testing according to ICH Guidelines
• Generation of data and preparation of reports appropriate for regulatory submission

IriSys provides stability studies of the following materials:

• Bulk drug substances
• Solid dosage form units
• Semi-solid dosage form units
• Oral liquid dosage form units
• Injectable dosage form units