OBJECTIVE:
To lay down a procedure to ensure compliance of approved raw material at regular interval 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 store one month in advance for the material due for retesting.
- After the receipt of re-testing intimation slip from store department, QC Chemist shall make its entry in the respective Re-testing logbook
- Affix “UNDER RETEST” label on each container and cross out “APPROVED” label with 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.
- Description
- LOD/Water content
- Chromatographic purity/Related substances
- Assay
- pH
- Acidity / Alkalinity test
- Prepare retest report, check and get it signed by QC Manager or his/her designee
- Affix “APPROVED” label with new retesting date on all the containers.
- If material is rejected, Affix “REJECTED” label on each container.
ABBREVIATION(s):
SOP : Standard Operating Procedure
No. : Number
L.O.D : Loss on drying
Q.C : Quality control
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