SOP FOR ASSIGNING OF MANUFACTURING AND EXPIRY DATE TO A FINISHED PRODUCT
PURPOSE: To lay down the procedure to assign manufacturing and expiry date to a finished product.
SCOPE: This SOP is applicable to assign expiry date to a finished product.
RESPONSIBILITY:
Preparation of SOP: QA Officer/ Sr. Officer
Checking and Review of the SOP: Executive/Sr. Executive
Approval of SOP: Head of Department/ Assistant Manger
Authorization of SOP: Head QA/Designee
Personnel/officer /Executive QA shall be responsible for assigning manufacturing expiry date to batch of finished product.
Executive -warehouse to provide manufacturing and expiry date details of the dispensed active ingredients.
ACCOUNTABILITY: The accountability of implementation and compliance of the SOP is of Executive QA / Head QA.
PROCEDURE:
Manufacturing date: The date of manufacturing date is the month in which raw materials (active or 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.
A tentative expiry dating period of up to 24 and 36 months will be assigned to all solid dosage forms, if the drug has retained 90% of its original potency after 90 days storage at 40oC ±2oC/75%±5%. The same shall be confirmed by long-term stability studies.
A tentative expiry dating period of up to 36 months will be assigned to lyophilized injection and up to 24 months will be assigned to liquid injection dosage form, if the drug has retained 90% of its original potency after 90 days storage at 400C ± 20C/75% ± 5%RH. The same shall be confirmed by long-term stability studies.
The expiry date of a drug product should not exceed the expiry date of the drug substance. Executive-WH shall include the expiry date of the active ingredient on the Weighing record during dispensing. In case expiry date is not applicable for a drug substance and only retest before date is available, the Executive-WH shall indicate that expiry date is not applicable.
Note: In case of dispensing more than one lot of an active ingredient, the expiry dates of each of the lots dispensed shall be included in the Weighing record.
The expiry date for a batch of finished product shall be calculated from date of manufacture of product. The expiry date column shall be filled in by the Executive PD as per the listed shelf life for the product and the shelf life of the active ingredient being used in the batch. Executive-QA during batch record review, shall verify this expiry date.
For e.g., If the date of manufacture of a drug product is 5 Dec.2025, and the drug product has a shelf life of 3 years, then the date of expiry shall be Nov 2027. Similarly, if date of manufacture of a drug product is 31st Dec.2025 and drug product has a shelf life of 3 years, then the date of expiry shall be Nov 2028.
To assign expiry date to a finished product containing more than one active ingredient, assign the earliest expiry date of either of the active ingredient based upon expiry date of each of the raw material allotted by the manufacturer. E.g. In a combination formulation of A, B and C, the expiry date assigned is Dec 26 based on individual expiry dates of A (Dec ’26), B (Dec ’27) and C (Oct ’28).
The date of expiry for finished product will include only the month and year and it is expected that the product will meet specifications through the last day of that month. Month will be specified in numerical like 25,26,27…… respectively, whereas year will be specified in numerical as 2025, 2026, 2027,2028, etc”.
If the production lot/batch contains reprocessed material, the expiry date period shall be computed from the date of manufacture of the oldest reprocessed lot.
For primary and secondary packages, the expiry date shall be coded as “XX/YYYY” where 6(XX” is the month and “YYYY” is the year of expiry with a “/”separating the month and year”.
If it is mentioned especially in the product specification/export order, then the format of Mfg. &Exp. Dates will be as per party’s requirement.
REFERENCE:
SOP for SOP