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What is the shelf life?
- The Shelf Life is a quarterly newsletter published by SUSS Library to keep the SUSS community updated on the library’s new resources and services. This newsletter is also beneficial for students as it also encompasses useful information on research. Stay up to date on library happenings via The Shelf Life.
What is The Shelf Life? - Library FAQs
libanswers.suss.edu.sg/faq/272342What is a shelf life specification?
- Specification is a list of tests, reference to analytical procedures, and proposed acceptance criteria, including the concept of different acceptance criteria for release and shelf-life specifications. Shelf-life acceptance criteria should be derived from consideration of all available stability information.
ASEAN GUIDELINE ON STABILITY STUDY OF DRUG PRODUCT
www.hsa.gov.sg/docs/default-source/hprg/therapeutic-products/guidance-documents/asean-guideline-stability.pdfWhat is a shelf-life date?
- The date placed on the container label of a drug product designating the time prior to which a batch of the product is expected to remain within the approved shelf-life specification if stored under defined conditions.
ASEAN GUIDELINE ON STABILITY STUDY OF DRUG PRODUCT
www.hsa.gov.sg/docs/default-source/hprg/therapeutic-products/guidance-documents/asean-guideline-stability.pdfHow long should the extrapolated shelf-life be?
- The extrapolated shelf-life may be up to twice, but should not be more than 12 months beyond, the period covered by long term data, depending on the change over time, variability of data observed, proposed storage conditions and extent of statistical analyses performed.
ASEAN GUIDELINE ON STABILITY STUDY OF DRUG PRODUCT
www.hsa.gov.sg/docs/default-source/hprg/therapeutic-products/guidance-documents/asean-guideline-stability.pdf
