To lay down a procedure for assigning manufacturing and expiry date to the finished products being manufactured.
This SOP is applicable for assigning manufacturing and expiry date to the finished products being manufactured at (Company Name).
Production Personnel shall be responsible for assigning manufacturing and expiry date to batch of finished product.
Head Production department shall be responsible for the implementation of this SOP.
Head Production and Head QA shall be accountable for implementation of this SOP.
Abbreviations and Definitions
SOP:Standard Operating Procedure
QA :Quality Assurance
Manufacturing date: The manufacturing date is the month in which raw materials (active and excipient’s) 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
Production Personnel shall assign the manufacturing date to the batch of finished product 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 Sep of the year 2016, then the manufacturing date assigned to the batch shall be ‘Sep- 2016’.
Production Personnel shall assign the expiry date to the batch of finished product 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 Domestic market:
If a product is having more than one API, then expiry of the finished product shall be that of API with the earliest expiry.
A product formulated with two APIs is manufactured in July 2016 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.
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.
For Example: A product formulated with two APIs is manufactured in Oct 2016 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.
Note: The API(s) to be used in 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 APIs, the assigned expiry date shall be that of the API with the shortest shelf life.
For export market:The expiry date shall be assigned as per respective regulatory requirement.
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 Product of customers:- in case expiry date of the API is less than the shelf life of the Product, then customer approval shall be taken before assigning expiry date to the product.
Forms and Records (Annexures)
Master Copy – Quality Assurance
Controlled Copy – Production, Stores, Quality Control, Quality Assurance
Reason for Revision