Procedure for Assigning Manufacturing & Expiry Date/Retesting Date

1.0	PURPOSE To lay down a procedure for manufacturing & expiry date/retesting date for the intermediates and API.
2.0	SCOPE This method is applicable to given manufacturing & expiry date/retesting date for the intermediates and API.
3.0	RESPONSIBILITY Executive Quality Assurance.
4.0	ACCOUNTABILITY Head Quality Assurance.
5.0	PROCEDURE
5.1 5.1.1 5.1.2 5.1.3 5.2 5.2.1 5.2.2 5.2.3 5.2.4 5.2.5	Assignment of manufacturing date: The manufacturing date of the intermediate or the product should be assigned on the basis of the date of charging the project.  For ex. If the product is charged on 30 June 2006, the manufacturing date should be mentioned as June 2006. For mixed batch the manufacturing date should be the month in which a mixed batch is manufactured. For reprocessing batches the manufacturing date is assigned based on the date of reprocessing/ rework. Assignment of expiry  date: Following are the criteria to assign the expiry date of the drug product/API. Schedule P of drugs and cosmetic R & D lab recommendation Stability Study Data Expiry of raw material active For local requirement, shelf life of the product listed in schedule P of Drugs and Cosmetic Acts.1940 should be followed. The products which do not appeared in “schedule P” the expiry should be assigned on the basis of Stability data. For drug intermediates retesting date should be assigned instead of the expiry date. The retesting date should be assigned based on recommendation of R&D lab or based on stability studies Conducted on intermediates. For Reprocessing / Reworked batches the expiry date is assigned based on the date of expiration of the oldest constituent batch as explained above.
6.0	REFERENCES Nil

7.0

ANNEXURES

Annexure No.	Title of Annexure	Format No.
NA

8.0	ABBREVIATIONS

Abbreviations					Full Forms
SOP					Standard Operating Procedure
QA					Quality Assurance
API					Active Pharmaceutical Ingredient.
9.0   DISTRIBUTION
Master Copy						Head Quality Assurance Department
Controlled office Copy No. 1						Head Quality Assurance Deptt.
10.0	REVISION HISTORY
S.No.		Revision No.	Effective Date	Reason for Revision			Details of Change	Authorized By (sign & Date)