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. | Date | Name of Raw material | Item code No. | Mfg. B. No. | Mfg. date | Exp. date |
| | | | | | | |
| GRN No. | Manufacturer / Supplier | Re-test Due on | Sampled by | A.R. No. / Date | Withdraw by | Remarks |
| | | | | | | |
| Format:-F/QC/012 | ||||||
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