Saturday, November 27, 2010

Re-Testing of Raw materials

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 of --------Pharmaceuticals Ltd,Ankleshwar.

4.0         Responsibility  :
·       Primary   : QC Chemist / QC Officer
·       Secondary : Overall: QC – Incharge

5.0       Procedure:
·        After the receipt of re-testing intimation note from store department, QC Chemist takes its entry in the respective Re-testing logbook and give 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.  

6.0      Reference Document:
v     Re-testing of raw materials logbook.

     log book for Re-test raw material

S. No.
Name of Raw material
Item code No.
Mfg. B. No.
Mfg. date
Exp. date


Manufacturer / Supplier
Due on
Sampled by
A.R. No. / Date
Withdraw by


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