STANDARD OPERATING PROCEDURE LONG RANGE AND ACCELERATED STABILITY STUDIES OF PRODUCT

STANDARD OPERATING PROCEDURE

SUBJECT :                     LONG RANGE AND ACCELERATED STABILITY STUDIES OF PRODUCT

DEPARTMENT           : QA SOP NO.                      : Page No                       : Effective Date             : Next Review                : SOP VERSION            :

1.0       OBJECTIVE:

           

1.1       To establish shelf life of product.

1.2       To ensure that the Commercial batch continues to meet the specified standard during the anticipated shelf life.

1.3       To improve the quality of product by studying the physical and chemical changes that the product exhibits during the anticipated shelf life.

2.0       SCOPE:

To evaluate product stability of commercial batches of finished product and to assure compliance with laid down standards.

3.0       PROCEDURE:

3.1       Each and every marketed product will be included in stability study program if required by the principal company. In case of new products or where established product is reformulated significantly, samples from two/ three commercial batches will be included in the stability program. Thereafter, at random the samples of the products are drawn & at least one batch in a year is charged for Long Range Stability.

3.2       All samples will be stored at ambient temperature or 30 ± 2°C /65± 5%RH, 40± 2°C /75± 5%RH and 25°C± 2°C /60± 5% RH as specified by the principal company QA/R&D.

3.3       All the samples will be charged within 30days from the date of finished product approval.

3.4       In case of products having an expiry date of greater than 24 months, complete physical test and chemical assay shall be performed at initial, 1, 2, 3, 6, 12, 18, 24, 30 & 36 respectively.

              For products with 3& 5 years the testing shall be at 1, 2, 3, 6, 9, 12,18, 24, 30, 36, 42, 48, 54, 60, 66 months or as specified by the concerned principals.

3.5        All the products having expiry date will be tested for at least six months beyond the expiry date.

3.6       Long range stability record will be prepared for each batch subjected to stability testing.

3.7       pulling of samples for analysis the time frame will be 7 days (one week). The samples will be kept

            in A/C storage area for any delay to test to maintain status of sample integrity. The samples need

           to tested within 1week after pulling.

3.8       Stability results shall be recorded in the stability data file/register and analytical register.

3.9       G.M (Q.A) will ensure that stability studies are monitored on the selected batches of products and will scrutinize the stability results and take appropriate action in case of any observations.

3.10     Incase of Accelerated stability the product is stored at specified conditions and stability program will be drawn, samples will be tested as per schedule and record will be maintained. Incase if the samples do not meet specification the concerned principals will be informed.

3.11     Incase if the stability cabinet s break down we have a facility to store the samples in our sister concerns (ESPI) stability cabinets until the cabinets get repaired.

3.12    Incase if the stability sample results are not within the specified limits then the OOT investigation report need to be shared with the principal company with CAPA and OOT criteria need to be mentioned in the closure report.

4.0       FREQUENCY: As and when required.         

5.0       RESPONSIBILITY: QA Executive/G.M (Q.A).

6.0       REVIEW GUIDE:  Stability record.

7.0       ANNEXURE:

1.      Format for stability program

2.   AFHR stability data

8.0       SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

Name of the Department	Master  Copy	Circulatory Copy
QA/QC	√	√
Production	x	x
Warehouse	x	x
General	x	x
Maintenance	x	x