SOP for Assigning Manufacturing & Expiry Date/Retesting Date

PURPOSE

To lay down a procedure for manufacturing & expiry date/retesting date for the intermediates and API.

SCOPE

This method is applicable to given manufacturing & expiry date/retesting date for the intermediates and API.

RESPONSIBILITY

Executive Quality Assurance.

ACCOUNTABILITY

Head Quality Assurance.

PROCEDURE

Assignment of the manufacturing date:

• The manufacturing date of the intermediate or the product should be assigned on the basis of the date of charging the project. For ex. If the product is charged on 30 June 2020, the manufacturing date should be mentioned as June 2020.
• For mixed batch, the manufacturing date should be the month in which a mixed batch is manufactured.
• For reprocessing batches, the manufacturing date is assigned based on the date of reprocessing/ rework.

ALSO READ: SOP for Handling Out of Specification (OOS)

Assignment of expiry date:

• Following are the criteria to assign the expiry date of the drug product/API.

1. Schedule P of drugs and cosmetic
2. R & D lab recommendation
3. Stability Study Data
4. Expiry of raw material active

• For local requirements, the shelf life of the product listed in Schedule P of the Drugs and Cosmetic Acts 1940 should be followed.
• For the products that do not appear in “schedule P” the expiry should be assigned on the basis of Stability data.
• For drug intermediates retesting date should be assigned instead of the expiry date. The retesting date should be assigned based on the recommendation of the R&D lab or based on stability studies Conducted on intermediates.
• For Reprocessing / Reworked batches the expiry date is assigned based on the date of expiration of the oldest constituent batch as explained above.

REFERENCES

Nil

ANNEXURES

Nil

ABBREVIATIONS

SOP:  Standard Operating Procedure

QA:  Quality Assurance

API:  Active Pharmaceutical Ingredient.

REVISION HISTORY
Nil

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