Wednesday, December 1, 2010

Instruction for Preparation of Certificate Of Analysis

1.0      Purpose      :    To provide an instruction for preparation of Certificate of Analysis.

2.0      Objective   :   To provide a documented procedure for preparation of Certificate of Analysis for raw materials, packing materials, intermediates, finished products.

3.0     Scope     :    This procedure is applicable for preparation of certificate of analysis in QC department.

4.0     Responsibility  :
·       Primary        :     QC Chemist / QC Officer
·       Secondary    :      Manager QC
5.0       Procedure   :
·       Quality control department prepares following certificates.
Ø      Certificate of analysis for raw materials / packing materials.
Ø      Certificate of analysis for intermediates.
Ø      Certificate of analysis for finished products.
Ø      Certificate of analysis for stability samples.
·        After completion of testing, QC Chemist shall prepared certificate of analysis for respective samples.
·        QC chemist shall attached related graphs, worksheet with this certificate of analysis.
·        Chemist shall sign in the certificate of analysis at analyzed by column.
·        Then handover to QC In-charge for approved by signature.
·        After clearance from QC In-charge, filed the document in respective file.
·        One copy is transfer to Q A department for archiving.
            

       ANNEXURE I
CERTIFICATE OF ANALYSIS

Product


QC Report No.
Batch No.


Date of Receipt :
Date of Mfg.


Date of Analysis :
Exp. Date


Batch Size :



Qty. Sample :
RESULT OF ANALYSIS
Sr. No.

TEST

OBSERVATION
SPECIFICATION
1



2



3



Remark
Pass/ Fail


Report :
In the opinion of the undersigned the sample referred to above is of / is not of standard quality as defined in the Act & Rules made there under of EP-6




Analysed By                                           Checked By                                                         Approved By

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