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