Re-testing of raw materials and intermediates

1.0        Purpose   :    To provide an instruction for re-testing of raw materials and intermediates.

2.0          Objective: To provide a documented procedure for re-testing of raw materials and intermediates.

3.0            Scope  :   This procedure is applicable for re-testing of raw materials and intermediates in QC department.

4.0        Responsibility  :

·       Primary   : QC Chemist / QC Officer

·       Secondary : Overall: QC – Incharge

 Procedure:

·        After the receipt of re-testing intimation note from store department, QC Chemist takes its entry in the respective Re-testing logbook and gives AR No. to raw materials or intermediate.

·         AR No. Should be given as follows

  For Raw material: R-XXX/ZZ/R1 (e.g. R-001/08/R1)

  Where, R         = raw material

                XXX    = serial no. (e.g. 001, 002, ….)

                ZZ        = year (e.g. 2008 as 08)

                R1       = re-test first time (e.g. R1, R2, ….)

Collect samples as per sampling plan.

·        After completion of sampling, do the necessary critical tests (e.g. assay, LOD, water content, pH, specific optical rotation etc.) as per the Standard Analytical Procedure.

·        Raw material may also be approved on the basis of physical appearance.

·        After completion testing, put the status of approved / rejected on the containers.

·        Re-testing of any raw materials should be four times only.

·        Frequency of re-testing for raw material is every year, and for intermediate is every six months. 

·        Re-testing should be performing on first come first out basis. The re-testing of material   should carry out, whose due date for re-test is earlier.