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 K. Patel Phyto Extracts Pvt Ltd.
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 TR No. to raw materials
or intermediate.
· TR No. Should be given as follows
For Raw material: KP/RM/RT/000/XX-YY
Where, KP
= K. Patel
RM = Raw Material
RT = re-test
000 = T.R. Number
XX-YY = year (e.g. 13-14)
· 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:
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
|
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