STABILITY STUDY

1.0. PURPOSE:
To provide a procedure for Stability study.

1.1. To gain a thorough understanding of any chemical and physical changes and
microbiological changes to which the formulations may be exposed during the
shelf life under different storage conditions.

1.2. To confirm that our formulations are stable and satisfactory in marketed pack through out the cycle of ware housing distribution , storage and use.

1.3. To recommend storage conditions, retest periods and shelf life.

1.4. To monitor any impact of changes in manufacturing process and its impact on product
quality on long term storage .

2.0. SCOPE:
To assign responsibility for the preparation & control of Batch record.

3.0. RESPONSIBILTY:
Quality Control Chemist

4.0. Accountability:
Manager -QC

5.0. Definition:
NIL

6.0. PROCEDURE:
6.1. Stability study sample to be kept in marketed pack or similar to the marketed pack. e.g. Blister pack and Bulk pack.

6.2. If a product is more than one pack , stability studies should be carried out on
each of the packs.

6.3. Quantity of the sample should be sufficient for 12 individual analysis on the test selected .

6.4. Container / closure evaluation should be for in-process, storage transportation of products, compatibility with packaging materials, moisture permeation , light exposure and closure sealability .

6.5. Selection of batches and storage condition for stability studies

6.6. First three trial or pilot batches at accelerated temperature and humidity say 40 ° C/ 75% RH at 4,8,12 and 26 weeks.

6.7. First three production batches at long term stability . 4,8,12,26,52,78,104,130,156 weeks at 25°C/ 60% RH

6.8. RT : 8,12,26, 52,78,104,130,156 weeks
6.8.1. 30°C /60% RH
6.8.2. 37 ° C : 4,8,12,26 weeks
6.8.3. 45 ° C : 4,8,12 weeks

6.9. One regular production batch every year for long term stability study i.e, 25°C /60%RH, 30°C /60% RH, RT , 37°C .

6.10. Batch in which there is a change in process or container, closure/ of primary packing or RM sources for accelerated stability evaluation i.e, 40°C /75%RH , RT , 37°C.

6.11. Selection of parameter for evaluation

6.11.1.
a) Chemical stability.
b) Physical stability.
c) Micro biological stability.

6.12. Stability testing protocols.: Protocols should describe the details

6.12.1. Description of pack .

6.12.2 Frequency of testing

6.12.3. Storage conditions.

6.12.4. Assessment of results

6.13. Assessment and submission of stability study data

6.13.1. Review of results at each interval to see if there are significant changes / variation of results by more than 5% of the initial value

6.13.2. Suggestion of changes / improvement based on stability strength.

6.13.3. Annual summary of the batches under stability .

6.13.4. Revision in storage condition of the product based on the results

6.13.5. Recommendations for the change in pack based on the results.