Pharmaceutical Stability Study Guideline

Guidelines for conducting stability studies for new products are as follows:
1. Formal stability studies should include accelerated and long-term stability testing in at least two primary production batches for stable drug products and at least three primary production batches in the case of sensitive drug products.

2. Accelerated stability test data at 40°C / 75% for a minimum of six months and long-term stability test data at 30°C / 65% for a minimum of 12 months should be available at the time of submission of the new drug application and may continue.

3. The product is stable for 6 months at 40°C / 75% (accelerated stability test conditions) then it can be assigned a shelf life of 24 months.

4. If a shelf life period of more than 24 months is assigned to the product, real time stability testing data should be available.

5. Although not internationally accepted, as an internal policy decision we may grant a shelf life of 36 months if the product is found stable under accelerated stability test conditions of 40°C / 75% for 12 months.

6. After completion of long-term stability test for 36 months or more, a period of 36 months or more in drug development may be prescribed.

7. If there is a change in the primary packing material, the product should be treated as a new product for conducting stability studies.

8. Stability studies should be performed on each individual strength of the drug product unless bracketing is applied.

9. If the same product has different dosages (different strengths) and identical manufacturing composition, but different manufacturing processes then each should be considered as a new product and stability studies should be done separately for each strength.

10. The frequency of testing for long-term stability testing should begin with every 3 months in the first year, every 6 months in the second year, and annually thereafter throughout the recommended shelf life.

11. Frequency of testing for accelerated stability testing should be initial 3 months and 6 months.

12. Ambient conditions or room temperature conditions are not acceptable when labeling stability samples.

13. Stability testing should cover chemical, physical, biological and microbiological properties including the testing of preservatives and those properties of drug products which are susceptible to changes during storage and may affect the quality, safety and/or efficacy of the drug product. .

14. Of the three batches selected for stability study testing, at least two batches should be pilot scale batches and the third may be smaller if justified.

15. Photostability testing should be done on at least one initial batch of drug product.

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