Vanton has been PAI inspected by FDA on its stability program for commercial products in 2011 and in 2016 that led to its current commercial stability programs for the clients globally (Prodcuts: Stendra and Spedra). Other than the commercial stability program, Vanton also runs the stability programs for R&D, pre-clinical and clinical stages.
To conduct a stability program, Vanton will:
- Develop the methods needed for stability indicating (e.g., assay, dissolution, content uniformity, water content, hardness, purity, physical, microbial, disintegration, etc.)
- Conducts validation for the developed methods or conduct method transfer from existing methods
- Establish stability protocols (timeline, sample information, methods, deviation control, OOS/OOT handling), project manage the program, and reporting
- Maintain environmental chambers with 24/7 monitoring system and backup power (various configurations covering most zones are available)
- Run the stability methods, perform analysis, and report the data professionally on time and consistently
- Perform thorough Quality Assurance