Accelerated stability expiration dating
Index
- Can accelerated testing data be used to estimate expiry dates?
- How do you justify an expiration dating period of more than 3 years?
- How long does accelerated stability testing last?
- Is it appropriate to extrapolate stability data?
- Is accelerated shelf life testing right for your product?
- How are expiration dates established in the FDA?
- How are expiry dates assigned to in vitro diagnostic reagents?
- How do you justify an expiration dating period of more than 3 years?
- Can stability testing be performed at an accelerated rate?
- What is accelerated shelf life testing?
- How long does it take for stability testing data to be available?
- How often should I test the stability of my product?
Can accelerated testing data be used to estimate expiry dates?
The use of accelerated testing data to establish a tentative expiration dating period exceeding three years is discouraged when it is based solely on accelerated testing data. Based on the combination of data collected at room temperature and at accelerated temperature, it is possible to justify an expiration dating period of over two years.
How do you justify an expiration dating period of more than 3 years?
The use of accelerated testing data to establish a tentative expiration dating period of greater than three years is discouraged when it is based solely on accelerated data. Combining data compiled at room temperature and at accelerated temperature is possible to justify an expiration dating period of over two years.
How long does accelerated stability testing last?
Accelerated stability testing may be completed on one batch in order to establish a tentative expiration date. Using the data from accelerated testing to establish a tentative expiration dating period of greater than three years is discouraged when it’s based only on accelerated data [1].
Is it appropriate to extrapolate stability data?
Whether extrapolation of stability data is appropriate depends on the extent of knowledge about the change pattern, the goodness of fit of any mathematical model, and the existence of relevant supporting data. Statistical analysis can be useful in supporting the extrapolation of retest periods or shelf lives.
Is accelerated shelf life testing right for your product?
ACCELERATED AGING OR ACCELERATED SHELF LIFE TESTING IS AN ACCELERATED SHELF LIFE TESTING A GOOD FIT FOR YOUR PRODUCT? Shelf stable and frozen products with a shelf-life of six months or more are good candidates for accelerated shelf life studies.
How are expiration dates established in the FDA?
2. How are expiration dates established? FDA regulations require drug applicants to provide stability testing data with a proposed expiration date and storage conditions when they submit an application for FDA approval of their drug.
How are expiry dates assigned to in vitro diagnostic reagents?
Expiry dates are assigned to in vitro diagnostic reagents, calibrators, quality controls, and other components by the manufacturer based on experimentally determined stability properties. Typically, two approaches can be used to generate the stability data necessary to establish an expiration date for a diagnostic reagent.
How do you justify an expiration dating period of more than 3 years?
The use of accelerated testing data to establish a tentative expiration dating period of greater than three years is discouraged when it is based solely on accelerated data. Combining data compiled at room temperature and at accelerated temperature is possible to justify an expiration dating period of over two years.
