The FDA requires that a stability study must be performed on the product to support the submission of the consistency evaluation. The stability data package usually includes the stability profile of the product to justify specifications, and proposed expiry for the product. Alfa Chemistry derives shelf life criteria from all available stability information, and determines the expiration date of your generic product based on the stability assessment and the expiration date of the Reference Listed Drugs (RLDs).
Figure 1. Image from: Healthline Media LLC
Prediction of Expiration Date from Stability Data - Extrapolation Approach
If the prescription or production process of generic drugs is different with that of the RLDs, we conduct stability studies on multiple batches of samples to obtain more complete stability information to extrapolate the expiration date of the product.
- For the RLD product labeled "store below 25°C" or "store below 30°C", the maximum extrapolation of expiration date is up twice, but is not be more than 12 months beyond the period covered by long-term data
- For the RLD product labeled "store below 8°C", the maximum extrapolation of expiration date is up to one and a half times but not be more than 6 months beyond the period covered by long-term data
Our Standard Workflow
- Analyze the results of accelerated and long-term stability testings:
We conduct research on the stability testing data of at least three batches of products (different scales).
(1) Firstly, we perform a stability testing based on the requirements of reaction kinetics to predict the product's expiration date.
(2) Then, the results of long-term testing is used to predict the product's expiration date.
(3) The analysis results of the data of long-term testing is compared with the extrapolation result of the accelerated stability testing.
- Comparative analysis of the quality research results of the RLD and generic drugs
- Statistical analysis of data
If there is no statistical difference in the data of stability testing of different scales, it can be considered that there is no difference in the stability of different batches of products during production.
We perform variance analysis of all quantifiable quality indicators to determine whether there are statistical differences between different batches of samples, and the variance analysis is conducted on the stability data of small-scale batch and pilot-scale batch.
- Determination of the expiration date of generic drugs
A long-term testing is carried out on the product while in its final container and packaging to determine the final expiration date of the product.
Cooperate with Us
- Rich technical experience in the development and production of generic drugs
- Useful software tools and statistical methodologies
- Science-based and risk-based methods that conform to the principles of QbD and DoE
- Robust quality systems and appropriate data
- Meaningful contributions to stability testing
