SOP for Retesting Schedule of Raw Material

OBJECTIVE

To lay down a procedure to ensure compliance of approved raw materials at regular intervals during storage 

SCOPE

This SOP shall be applicable for all approved raw materials which are stored in the raw material store. 

RESPONSIBILITY

Implementation: Chemist and above Quality Control department. 

Checking: Asst. Manager and above Quality Control department 

PROCEDURE

• All active and inactive raw materials shall be retested after one year from the date of release.
• Intimation shall be received from the store one month in advance for the material due for retesting.
• After the receipt of the re-testing intimation slip from the store department, QC Chemist shall make its entry in the respective Re-testing logbook.
• Affix the “UNDER RETEST” label on each container and cross out the “APPROVED” label with a marker on all the containers.
• Sample the Raw material as per the current version of SOP. (Sampling plan of raw Material).

• Carry out the following test for each raw material as applicable.

1. Description
2. LOD/Water content
3. Chromatographic purity/Related substances
4. Assay
5. pH
6. Acidity / Alkalinity test

• Prepare the retest report, check and get it signed by QC Manager or his/her designee.
• Affix the “APPROVED” label with the new retesting date on all the containers.
• If the material is rejected, Affix the “REJECTED” label on each container.

ABBREVIATION

SOP: Standard Operating Procedure 

No.: Number 

LOD: Loss on drying 

QC: Quality control

ANNEXURE

Nil

REVISION HISTORY

Nil

ALSO READ: SOP for Sampling Plan of Raw Materials