RETESTING OF RAW MATERIALS

1.0 OBJECTIVE
To lay down a procedure for retesting of active ingredients and excipients.
2.0 SCOPE
This SOP covers procedure for Retesting of Raw materials and this sop is applicable
for Quality control department.
3.0 RESPONSIBILITY
Quality Control Chemist.
4.0 ACCOUNTABILITY
Department head.
5.0 PROCEDURE
5.1 The retesting schedule shall comprise of the list of raw materials, retesting should be carried out for each material during retesting period.
5.2 Warehouse shall take a print out of Raw Materials which are due for retesting in the next month and issue the list to Quality Control Department in the first week of the month.
5.3 Quality Control will plan the Sampling and Testing of the materials in such a way that the testing is completed before the date mentioned in the Retesting Schedule.
5.4 Sample the materials as per the SOP on “Sampling of Raw Materials”. Enter the details in Raw Materials Inward Register and allot a new Analytical Reference Number.
5.5 Carry out the tests as mentioned against in the respective Raw Material Specification, tests to be carried on retesting. Enter the data in Analytical Report.
5.6 On re-analysis if the assay on as is basis is found to be higher than the initial assay as is basis , then the initial values of assay on anhydrous basis and Water / LOD content at the time of retesting values shall be incorporated on the label.
5.7 Approve / reject the material and Affix the approved / rejected labels on the containers as per the laid down procedures.
5.8 In case of rejection, inform the same to the Materials Manager and Ware House Manager through a written note.
5.9 Ensure the shifting of rejected materials to “Rejection Area”.