SOP for Retesting Schedule of Raw Material

To lay down a procedure to ensure compliance of approved raw material at regular interval during storage 

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

Implementation: Chemist and above Quality Control department. 
Checking : Asst. Manager and above Quality Control department 

  • 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. 
  1. Description 
  2. LOD/Water content 
  3. Chromatographic purity/Related substances 
  4. Assay 
  5. pH 
  6. 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. 
SOP : Standard Operating Procedure 
No. : Number 
L.O.D : Loss on drying 
Q.C : Quality control 

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