SOP for Retest and Expired Materials

Purpose

To provide a procedure for the Retest and Expired Materials in the warehouse.

Scope

The scope of this SOP applies to the management of Retest and Expired Materials in a warehouse at PharmaInfo Ltd.

Responsibility

• Warehouse person: Identify and segregate the material that is due for retest and expires daily.
• Warehouse supervisor: Checking of material that is due for a retest and expired.
• Warehouse head: Overall responsibility for ensuring compliance with the procedure

Procedure

Handling of retest material

• Material due for retest is required to be transferred to the area designated for quarantine storage.
• The warehouse person shall check the material under retest daily and generate a list of materials due for retest for that particular day using material management software.
• The supervisor will verify the list and hand it over to the warehouse person who is responsible for material transfer.
• The warehouse person shall transfer the identified materials, which are due for retest to the quarantine area and store the same in available space.

• Material shall be stored in the area under suitable conditions applicable to the material.
• The material location chart shall be updated with the new location in the material management software.

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• Material shall be labeled with a Quarantine Label. Previously affixed labels with Approval status shall be defaced with the marker.
• Quality Control (QC) Laboratory will get the intimation through the material management software regarding material testing. QC will plan for the testing by considering the priority as per the production planning.
• Once the material testing is completed, the material status will get automatically updated in the material management system based on the result generated in the laboratory information management system. The material shall be transferred to the approved material area or rejected material area based on the quality.
• Rejected material shall be handled as per the procedure for SOP for Handling of Rejected Materials.
• In case any material needs to be used once after opening the container, it shall be tracked separately, and after dispensing, it shall be blocked with the help of QA and shall be destroyed as per the process of material destruction.

Handling of expired material

• The warehouse person shall check the expiry status of materials daily and generate a list of expired materials for that particular day using material management software.
• The supervisor will verify the list and hand it over to the warehouse person who is responsible for material transfer.

• The warehouse person shall transfer the identified expired materials and shall move them to the rejected area.
• The list of materials available in the rejection room shall be updated.
• Material shall be labeled/ stamped with ‘expired material’.
• In case of information received from the material manufacturer for extension of material shelf life, it can be done with adequate evaluation.
• To extend the shelf life, additional information regarding the stability study of the material, the container closure system of the material in which the stability study was performed, and updated CoA from the manufacturer shall be acquired.
• Once the information is received, it shall be reviewed by the warehouse head and further approval from the Quality Assurance Head shall be taken. The Quality Assurance Head shall evaluate all the supporting data thoroughly for shelf life extension.
• Once the expiry date is extended, it shall be updated in the material management software. The Retest interval shall be maintained based on the last retest done in the facility.

Frequency

For handling of all retest and expired materials.

Formats

Format for extension of shelf life

1. Material Name
2. Material Code
3. Material Manufactured Name
4. Stability Data availability for the duration
5. The container closure system is in line with stability data
6. Are the manufacturing process of stability batches and the batches for which the shelf life extension proposed is the same?
7. Data compiled by
8. Data checked by
9. Proposal approved by

Annexure

Nil

Revision History

Nil

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