SOP for Assigning of Manufacturing and expiry date to a Batch Product

1.0 OBJECTIVE :

To lay down the procedure for assigning Manufacturing and expiry date to a Batch product.

2.0 SCOPE:

The scope of the SOP covers the procedure for the assigning the Manufacturing and expiry dates to the batch product to be manufactured at [Company name].

3.0 RESPONSIBILITY:

3.1 Quality Assurance (QA) personnel to assign the Manufacturing and Expiry dates in the material management software.

3.2 Warehouse personnel verify allocated manufacturing and expiry date in BMR.

3.3 Head – Quality Assurance to ensure compliance.

4.0 PROCEDURE:

4.1 Manufacturing Date:

4.1.1 For the batch, manufacturing date is the date when material is dispensed for the batch manufacturing at [Company name].

4.1.2 Manufacturing / Expiry date can be assigned in following ways as the case may be:

4.1.2.1 Manufacturing / Expiry Date always given month wise for the product manufactured at [company name].

4.1.2.2 Any day of manufacturing (01 to 31) is considered for same month of manufacturing.

4.1.2.3 Manufacturing in month can assigned as example Apr ‘22 or Apr 2022. In other case the manufacturing and expiry shall be assigned as per the customer requirement. 

4.1.3 During time of dispensing warehouse personnel shall verify the Expiry Date in batch record after verifying with the shelf life of the product to be manufactured.

4.1.4 In case of Indian market product, if batch product consist of more than one Active Pharmaceutical Ingredients (API) lowest expiry date of any API to be considered for finalizing expiry of product to be manufactured. Hence, in any case batch expiry date of finished goods shall not exceed the expiry date of API used in that product.

4.1.5 In case of export product shelf life for the product is given on basis of stability data claimed. Hence, the expiry period on API does not matters for deciding expiry date / period for the product.

4.1.6 While considering expiry period on API for product to be manufactured, if expiry date of API mentioned day wise consider the previous month of expiry date unless this is not a last date of month.

4.1.7 In case of batch manufactured first time a tentative shelf life of up to 24 month considered for all solid dosage form if the drug has retained the potency level in control limit after 90 days / 03 months storage at 40° C± 2° C & 75 % RH ± 5%. 24 month shelf life shall be confirmed in long-term stability study.

4.2 Expiry Date

4.2.1 When expiry date given month wise this means that expiry period applicable up to last date of that month.

5.0 ANNEXURES: 

Nil