Thursday, November 25, 2010

Raw Material Sampling Method.

0   Purpose           :   To provide instructions for sampling of Raw Material for Testing Purpose.

2.0   Objective        :   To provide a documented procedure for raw material sample quantity for testing.

 3.0   Scope               :      This procedure for raw material sample method for testing in QC Department of
                              ------ Pharmaceutical. Ltd, 
4.0    Responsibility :
·      Primary     : QC Chemist
·      Secondary : Overall: QC Officer
                   
5.0   Procedure       :

·              On receiving the requisition of the raw material from the store. The QC Chemist                             will draw the sample from store with proper safety. If sample is in tanker from outside factory gate.
·              Sample will be done by the chemist with equipments such as.

Ø            If the sample is in crystal form & powder form the sample will be taken by       SS sample tube.
Ø            If the sample is in liquid form then sample will be taken by glass sample tube.
Ø            If the sample is in tanker the chemist will take the sample from the each compartment of the tanker of the bottom. And top of the each compartment with the help of glass sample tube.

·              Amount of the sample to be drawn.

Ø            If the sample is in solid form (like crystal or powder) then 50.0 Gms of the sample to be withdraw.
Ø            If the sample is in liquid form then 250.0ml of the sample to be withdraw.

·              Sample to be taken from each batch or lot as per the package label. If the package         
                       are less than 10. The sample should be drawn from each & every package are more                    than 10. Then sample should be taken as per this rule n + 1.
·              We after drawing the sample chemist will put the label of UNDER TESTING on the package or drums from where sample has been taken.
·              Chemist will bring the sample to QC lab and test the sample as per SOP of testing method.
·              If the sample is approved as per SOP then sample will be approved QC Manager and test report will be sent to store incharge and production incharge and chemist will put the approved label on the package of the new material and remove the under test label.
·              If the sample is not passed as per SOP testing method. The QC Manager will reject the raw material and sent the report to the store incharge and plant in- charge, after that QC Chemist will put the REJECT label on the package or drum and remove the UNDERTESITNG label.
·              here n = Number of package

6.0      Reference Document:

v             Raw materials logbook








Sr
No.
Date
Name of Raw material
Material code No.
Mfg. B. No.
Mfg. date
Exp. date








GRN No.

Manufacturer / Supplier
Qty. received/
No. of containers
Sampled by
Sampled qty.
A.R. No. / Date
Remarks







Format:-F/QC/001
             

7.0     Abbreviations:
·            QA   = Quality Assurance department
·            SOP = Standard Operating Procedure
·            QC = Quality Control

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