Sop on Assigning Manufacturing and Expiry date
To lay down a procedure for assigning manufacturing and expiry dates to the finished products being manufactured. & This SOP is applicable for assigning manufacturing and expiry dates to the finished products being manufactured at (Pharmaceutical Company Name).
Assigning Manufacturing and Expiry date – Responsibility & Accountability
Production Personnel shall be responsible for assigning manufacturing and expiry dates to batches of finished products. The Head Production department shall be responsible for the implementation of this SOP and Head Production and Head QA shall be accountable for the implementation of this SOP.
Abbreviations and Definitions for Assigning Manufacturing and Expiry Date
SOP: Standard Operating Procedure
QA: Quality Assurance
Manufacturing date: The manufacturing date is the month in which raw materials (active and excipients) are dispensed for manufacturing of the product.
Expiry date: It is the date till which a finished product is expected to remain within its approved finished product specifications.
API: Active Pharmaceutical Ingredient
AR.No.: Analytical Reference number
Procedure for Assigning Manufacturing and Expiry Date
Production Personnel shall assign the manufacturing date to the batch of the finished products in month and year format.
The manufacturing date for a batch of finished product shall be the month in which the raw materials (active and excipients) of that batch are being dispensed. For example, if the raw materials for a batch are dispensed in the month of August of the year 2023, then the manufacturing date assigned to the batch shall be ‘August 2023’.
Production Personnel shall assign the expiry date to the batch of finished products based on the manufacturing date of the batch.
The expiry date of the batch shall depend on the shelf life of the product, as prescribed in the BMR of the batch.
The assigned expiry date shall not be more than the shelf life of the product.
For the Domestic market:
If a product is having more than one API, then the expiry of the finished product shall be that of the API with the earliest expiry.
For Example:
A product formulated with two APIs was manufactured in August 2023 and has a shelf life of two years. The expiry of the first API is Dec 2023. The expiry of the second API is Nov 2023. Then the finished product shall be assigned an expiry date of Nov 2023.
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 the shortest shelf life.
For Example, A product formulated with two APIs was manufactured in November 2023 and has a shelf life of two years. The expiry of the first API is Dec 2023. The second API is added with two ARs. No(s); one with an expiry Mar 2023 and the other with an expiry Dec- 2023. Then the finished product shall be assigned an expiry date of Dec- 2023.
Note: The API(s) to be used in a batch should have more than 75% of the assigned expiry period available to rationalize the expiry of the Drug product w.r.t. marketing.
In products with more than one API, the assigned expiry date shall be that of the API with the shortest shelf life.
For the export market: The expiry date shall be assigned as per respective regulatory requirements and the Expiry Date shall be printed on the items i.e. Carton, Foil, label, etc. as per the product registration and countries-specific format requirement e.g. MM-YYYY, etc.
For Products of customers:- In case the expiry date of the API is less than the shelf life of the Product, then customer approval shall be taken before assigning the expiry date to the product.
