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SOP for Retesting Schedule of Raw Material

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. 
  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. 
ABBREVIATION(s):
SOP : Standard Operating Procedure 
No. : Number 
L.O.D : Loss on drying 
Q.C : Quality control 

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