By editorial staff
Published in: European Pharmaceutical Review
Published on: April 18, 2013
Introduction: This year [(2013)] marks the 10th anniversary of the introduction of the International Conference on Harmonisation (ICH) guidance on stability testing of new drug substances and products (ICH Q1A(R2)) and the ancillary guidance on storage conditions (ICH Q1F). In 2003, the pharmaceutical industry thought that it had achieved its goal of globally acceptable stability requirements, but unfortunately, that early optimism rapidly dissipated. Less than two years later, the ASEAN (Association of South East Asian Countries) group had broken ranks with ICH guidance and introduced their own guideline on stability requirements. In particular, they mandated the use of 30°C/75%RH for the long-term storage conditions for climatic zone IV (hot and wet).
Guidances • Parameters • Planning • Regulations • Regulatory • Study Design
