Stability Testing of New Drug Substances and Products Q1A (R2)
Tuesday, 15th October 2019
11:00 to 12:00 CEST (Berlin, Paris, Madrid)
PRESENTED IN ENGLISHReplay
Stability testing of New Drug Substances and Products according to the guideline ICH Q1A (R2) which addresses the information to be submitted in registration applications for new molecular entities and associated drug products.
Topics as shelf life, storage conditions, climatic zones, stress testing, long term testing, intermediate testing and accelerated testing are considered and the content of the guideline is examined.
In order to meet the strict requirements of guidelines such as ICH, WHO, EMA, ASEAN or GMP constant climate chambers, in particular those in which pharmaceutical products are tested must be subject to regular validations. This webinar will explain the Guidelines and practical implementation in your Lab.