Assigning Manufacturing and Expiry date to the Finished Products

Assigning Manufacturing and Expiry date to the Finished Products

Objective

To lay down a procedure for assigning manufacturing and expiry date to the finished products manufactured.

Scope

This procedure shall be applicable to all products manufactured.

Responsibility

• Executive / Officer Production 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, Quality Assurance shall be responsible for compliance of this SOP.

Abbreviations and Definitions

• 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
• A.No. : Analytical Reference number

Procedure

• Executive / Officer Production 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 of Paracetamol are dispensed in the month of April of the year 2020, then the manufacturing date assigned to the batch shall be ‘April 2020’.
• Executive / Officer Production 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 technical direction 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.

For Example: A product formulated with two APIs is manufactured in Jan 2020 and has shelf life of two years. Expiry of first API is Dec 2020. The expiry of second API is Nov 2020. Then the finished product shall be assigned expiry date as Nov 2020

• 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 Jan 2020 and has shelf life of two years. Expiry of first API is Dec 2020. The second API is added with two AR. No(s); one with expiry Mar 2020 and other with expiry Nov 2020. Then the finished product shall be assigned expiry date as Nov 2020.

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.

For export market: The expiry date shall be assigned as per respective regulatory requirements.

• 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. DD/MM/YYYY, MM/YY, DD/MM/YY, MM/DD/YY, MM/DD/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

• Not Applicable

Distribution

• Master Copy   – Documentation Cell Quality Assurance
• Controlled Copy   – Production, Stores, Quality Control, Export, Quality Assurance

History