SOP For Shelf Life Of Finished Products

 

1.0              OBJECTIVE:

This SOP is to lay down to describe the procedure to establish the shelf life of finished product with respect to stability, active material used, to meet regulatory requirement.

2.0              SCOPE:

This SOP is applicable to the entire finished product manufactured at -----------------

3.0              RESPONSIBILITY:

Responsibility of this SOP complies of Quality Assurance HOD.

4.0              ACCOUNTABILITY:                       

The accountability lies upon Quality Assurance HOD.

5.0              PROCEDURE:

5.1              Standard Shelf - life:

5.1.1        Standard shelf life is based on the stability studies of the product. In any case shelf life of product should not be more than five years. (As per Schedule P).

5.2              With respect to active material’s expiry:

5.2.1        Shelf life of product also depends on the shelf life of active R.M. to be used in the product. If available shelf life of the active materials is less than standard shelf life of product then product’s shelf life will be the shelf life of active materials used.

5.2.2        In case of short expiry of the active RM, store raises a Short Expiry note and sends to QA Dept. QA dept after verifying the expiry of active Raw material changes the Expiry of the Finished Product.

5.3              With respect to reprocessed batch:

5.3.1        In case a new batch for any reason, of the product is to be reprocessed in the same month, then shelf-life will remain unchanged, but if it is reprocessed after few months, or a part of lot, is only reprocessed where other part is already packed & marketed then shelf life of the reprocessed lot will not be as per standard shelf life, but should be as per principal batch.

           

5.4              Acceptance criteria:

5.4.1        Standard shelf life should be based on the stability studies of the product or as per the schedule P.

5.5              Frequency: Every year based on the Stability Studies.

6.0              LIST OF ANNEXURE AND FORMATS:                            

Sr. No.	Title of Format	Format No.
01	NA	NA

7.0              REFERENCE:

7.1              SOP-QA- 001

7.2              F/QA-001-01

 

8.0              REVISION HISTORY:

Sr. No.	Date	Reason for Revision	Revision No
1.	31/10/2018	New SOP	R0
2.	31/10/2020	Schedule Revision	R1

9.0              ABBREVIATIONS:

Sr. No	Abbreviations	Details
	RM	RAW MATERIAL
	SOP	STANDARD OPERATING PROCEDURE
	HOD	HEAD OF DEPARTMENT

                       

END OF DOCUMENT