Raw materials retest procedure
Raw materials retest procedure
OBJECTIVE
To establish the retest procedure for the raw material.
SCOPE
This SOP is applicable to the approved raw materials in the Warehouse which must be subjected to retest.
RESPONSIBILITY
Warehouse Pharmacist and Warehouse Head shall be responsible for compliance with the procedure mentioned in this SOP.
ACCOUNTABILITY
Warehouse Head shall be accountable for compliance with the procedure mentioned in this SOP.
PROCEDURE
After approval of any raw material, register it in the log book of raw materials, and indicate the re-test date.
Retest should be conducted before the expiry date.
After receiving the re-testing request from QC, move the material to the quarantine area and attach the “Re-test” label.
After receiving the certificate of analysis of the re-testing materials and after labeling the raw materials with the “Approved” labels by QC department, write the note in the appropriate log book and move the material to the “Approved” area.
If the material does not pass the retest, move it to the rejected materials area after labeling by QC staff with appropriate labels and issuing the appropriate certificate of quality.
REFERENCES
- In-house
ABBREVIATIONS
- SOP: Standard operating procedure
- QA: Quality Assurance department
- QC: Quality Control
DISTRIBUTION LIST
- Quality Assurance Department
- Quality Control Department
- Warehouse
