STANDARD OPERATING PROCEDURE Stability Testing Of Products

. Purpose:
It is established for Stability Testing of Products.

2. Scope:
It is applicable to Product Testing.

3. Responsibility:
1. Manager F&D
2. F&D Analyst /F&D Pharmacist
1. Procedure
1. Testing is done Physically and Chemically on Pharmaceutical Products to assure the stability of Product.
2. Original containers to be used for stability testing.
3. Stability testing can be on going, first three consecutive batches of production and if formulation or packaging Material or the source changes.
4. All the products will be tested with the available testing procedures of the Products.
5. Stability studies are conducted at ambient storage condition/special storage conditions
The product is evaluated under following storage condition:
• Room temperature 15 oC to 30 oC
• Refrigeration 2oC to 8oC
• Accelerated condition 38oC + 2oC, 65% + 5% RH
6. Stability testing is performed at certain intervals confirming shelf life of the product.
7. Stability testing schedule is initially 6 months, 1 year, 2 years, expiry date and one year after expiry.
8. A stability study at accelerated conditions is one month equivalent to one year (38OC, 65% RH).
9. Results are documented in the folders and Manager F&D reviews the data.
Official Storage Conditions are defined as follows:
• Freezer = -10OC to -20OC
• Cold = NMT 8OC (Refrigerator= 2OC to 8 OC)
• Cool = 8OC- 15OC
• Room Temperature = 15OC- 30OC
• Warm = 30OC- 40OC
• Excessive heat = above 40OC