Stability testing is the primary tool used to assess shelf life and storage conditions for pharmaceutical products. Stability studies are linked to the establishment and assurance of safety, quality and efficacy of the drug product from early phase development through the life-cycle of the drug product.
MedPharm has extensive experience in conducting ICH stability studies for its clients throughout the drug development life-cycle. This includes short accelerated proof of concept programmes or on-site storage and analysis of GMP clinical trial materials.
Testing frequency can vary throughout the life cycle of a drug product. MedPharm can offer project-specific advice on defining these testing requirements. MedPharm’s Vindon Stability Cabinets are continuously monitored for performance using a state-of-the-art Environmental Monitoring System.
Storage Stability Conditions:
- 25ºC / 60% RH
- 30ºC / 65% RH
- 40ºC / 75% RH
- Photostability (ICH Options 1 & 2)
- Specialised conditions
Some samples can be put on accelerated stability studies, usually for 1 to 3 months, to better predict their success in long term studies as early as possible. These predictive studies are also acceptable as indicators for competent authorities, as long as the longer term study data (at least 12 months) under the standard conditions, is supplied when available.
As part of the process of identification of extractables and leachables, the product formulation and the packaging can under go stress testing which can include temperature, mechanical, chemical (corrosion) and microbiological stress testing.