Shelf life Assignment for the finished products.

1.0 OBJECTIVE

To lay down a procedure for assigning shelf life for the finished products.

2.0 SCOPE

This procedure is applicable to all the drug products manufactured at XXX, Company

3.0 RESPONSIBILITY

3.1 Head-Quality Assurance

4.0  PROCEDURE 

4.1 Assigning Manufacturing and Expiry Dates

4.1.1 The manufacturing date for a batch of finished product shall be the month in which the active raw materials of that batch are being dispensed.

4.1.2 For example, if the raw materials for a batch are dispensed in the month of SEP of the year 2018, then the manufacturing date assigned to the batch shall be ‘SEP, 2018’.

4.1.3 The expiry date of the product shall not exceed the expiry date of the drug substance (API).

4.1.4 The expiry date for a batch of finished product shall be calculated from the date of manufacture of product.

4.1.5 For example, if the date of manufacture of a drug product, DEC, 2018 and the drug product shelf life of 2 years, then the date of expiry shall be NOV,2020.

4.1.6 A product formulated with one APIs is manufactured in DEC, 2017 and has shelf life of two years. Expiry of API is OCT, 2019. Then the finished product shall be assigned expiry date as OCT, 2019 not NOV, 2019. 

4.1.7 If a product is having more than one API, then expiry of the finished product shall be that of API with the earliest expiry.

4.1.8 A product formulated with two APIs is manufactured in DEC, 2017 and has shelf life of two years. Expiry of first API is Nov 2019. The expiry of second API is Oct 2019. Then the finished product shall be assigned expiry date as Oct 2019.

4.1.9 When more than one AR No. of API(s) is used, then the assigned expiry date to the finished product shall be of the API with AR No. bearing shortest shelf life.

4.1.10 For Example: A product formulated with two APIs is manufactured in DEC, 2017 and has shelf life of two years. Expiry of first API is Nov 2019. The second API is added with two AR. No(s); one with expiry Feb 2019 and other with expiry Nov- 2018. Then the finished product shall be assigned expiry date as Nov- 2018.

5.0 ABBREVIATIONS: Nil

6.0 ANNEXURE: Nil

7.0 CHANGE HISTORY