1.0 Purpose: The purpose of this SOP is to provide instruction for the Retesting and Resampling of raw materials and intermediates.
2.0 Objective: To provide a documented procedure for Retesting and Resampling of raw materials and intermediates.
3.0 Scope: This procedure is applicable for the Retesting and Resampling of raw materials and intermediates in the QC department.
4.0 Responsibility :
4.1 QC Chemist / QC Officer to perform the sampling as per this SOP.
4.2 QC –Head/in charge of overall compliance with this SOP
5.1 After the receipt of the Re-testing intimation note from the Raw material store department, QC Chemist carries its entry in the respective Re-testing logs and test report no. to raw materials or intermediate.
5.2 Before the sampling, the QC officer shall follow the proper gowning procedure.
5.3 Collect samples for re-test as per the sampling plan.
5.4 After completion of sampling put the “UNDER RETEST” label and do the required tests (e.g. assay, microbial limit test, water content/LOD, pH, specific optical rotation, etc.) as per the Standard Analytical Procedure and STP.
5.5 After completion of testing, put the status of “APPROVED/REJECTED” along with the next re-test date on the re-tested containers.
5.6 Re-testing of any raw materials should be done as per the frequency.
5.7 The frequency of re-testing for raw material is every year, and for intermediate is every six months. The re-test due date of raw materials shall not be more than the expiry date.
5.8 Re-testing of raw material should be performed on a FIFO (first in first out basis). The re-testing of raw materials should be performed, the basis of whose due date for the re-test is earlier.
6.0 Reference Document:
Re-testing of raw materials logbook.
SOP: Standard operating procedure
QC: Quality Control
LOD: Loss on drying