Transcription of Current Practices in Shelf Life Estimation
{{id}} {{{paragraph}}}
Example: air traffic controller
Current Practices in Shelf Life Estimation
Current Practices in Shelf Life EstimationJames SchwenkeBoehringer Ingelheim Pharmaceuticals, ,PQRI Stability Shelf Life Working GroupShelf Life Estimation ICH Estimation methods Typical stability study Shelf Life paradigm Regression methods for estimating Shelf life Actual stability study results Summarize empirical distribution of estimated Shelf life Extend to random batch analysesAugust 1, 2010 Pharmaceutical Stability Shelf Life1 ICH Guideline Q1A defines Shelf Life (also referred to as expiration dating period) as The Shelf life for a pharmaceutical product is the maximum time at which a stability limiting characteristic stays within acceptance criteria. p Also in Q1A, Specification Shelf Life is defined as The combination of physical, chemical biological, and microbiological tests and acceptance criteria that determine the suitability of a drug substance throughout its re-test period, or that a drug product should meet throughout its Shelf life.
time at which the true mean response of a stability limiting characteristic crosses th e acceptance criterion.” – basis for the current ICH/FDA shelf life estimation procedure – limited assurance that individu al test results will comply with the specification up to m months – focus on the mean response imp lies the risk to fail ...
Loading..
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: