Matching Environmental Monitoring & Mapping To FDA/ICH Guidance For Better Stability Studies

Stability testing and monitoring is a critical step in drug research, development and manufacturing. It impacts how pharmaceuticals are produced, packaged, labeled and sold. Creating the exact environmental conditions in a stability test is a complex process, but necessary to comply with standards defined by regulatory bodies like ICH and the FDA, as well as to ensure the safety and efficacy of pharmaceutical products.

Guidance on stability monitoring for medicinal and pharmaceutical products is addressed by the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use). The final guidance has been adopted across Europe, Japan and the United States. Additionally, the FDA states in 21 CFR part 203 that manufacturers, authorized distributors of drugs and their representatives shall store and handle all drug samples under “conditions that will maintain their stability, integrity and effectiveness,” ensuring that the drug samples are free of contamination, deterioration and adulteration.