SOP for Assigning Manufacturing and Expiry Date of finished products in Pharmaceutical Industry
1.0 OBJECTIVE :
- To lay down the procedure for assigning manufacturing and expiry date to the finished product being manufactured.
2.0 SCOPE :
- This SOP is applicable for assigning manufacturing and expiry date to the finished products.
3.0 RESPONSIBILITY :
- QA Officer and above
4.0 ACCOUNTABILITY:
- Q.A. / Production Head
5.0 PROCEDURE :
5.1 Procedure of batch allocation is to be followed as per Allocation of Product Batch Number SOP
5.2 Check expiry date of API on container label. If found less than finished product then reduce shelf life of finished product to raw material’s shelf life, if more than one API to be used lowest shelf life of API to be given to finished product.
5.3 In case of active material (s) is not available, Purchase Department will ensure that shelf life of finished product is not beyond expiry date of active material (s).
5.4 Whenever shelf-life required reduction by 3 months or more take concurrence from business partners through marketing department.
5.5 On basis of all above three steps shelf life of finished product is to be finalized.
5.6 After finalization of shelf life of finished product as per requirement shelf life will be numerical or alpha-numeric system.
6.0 ABBREVIATIONS:
| Abbreviation | Expanded form |
| SOP | Standard Operating Procedure |
| Q.A. | Quality Assurance |
| GEN | General |
| QAD | Quality Assurance Department |
| e.g. | Example |
| API | Active Pharmaceutical Ingredient |
7.0 ANNEXURES:
Nil
8.0 SOP REFERENCES
- In-house
END OF THE SOP
