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Vender Appoval SOP [PHARMA IND]

Vender Appoval SOP [PHARMA IND]

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Published by Prem Goel
CRITICAL SOP,US FDA ,ALL REGULATORY BODIES HAVE A LOOK AT IT, GUIDELINES,
CRITICAL SOP,US FDA ,ALL REGULATORY BODIES HAVE A LOOK AT IT, GUIDELINES,

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Published by: Prem Goel on Jul 01, 2011
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08/21/2013

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STANDARD OPERATING PROCEDURE
 
Department:
Corporate Quality Assurance
SOP No.:
 
Area:
Company wide
Page No.:
1 of 9
Effective Da
 
Revision No.:
00
Valid Upto:Previous Revision Date Reason for Revision
--- --- New SOP
Subject
Procedure for Vendor Qualification and Approval
Prepared By Checked By Approved By
1.0 PURPOSE
To lay down the procedure selecting and approving the vendors. 
2.0 SCOPE
This procedure is applicable to vendor approval for all Raw Material, Packaging Materialand Labeling Material.
3.0 ABBRIVIATION/DEFINITIONS
Nil
4.0 RESPONSIBILITY
Head of Purchase & Head of QA are responsible for approving vendors.
5.0 PROCEDURE
5.1 Vendors for Critical Raw materials5.1.1 Material used in New Products
5.1.1.1 R & D shall generate tentative specifications for material to be used in the product. Basedupon these specifications, Purchase requisition is sent to Purchase Department forprocurement of material generally from 2-3 vendors, along with quantity required. Followingpoints must be included in Purchase requisition.
Pharmacopoeial Status of material if any.
Any in-House specifications which should be included on the basis of literature survey.
 
STANDARD OPERATING PROCEDURE
 
Department:
Corporate Quality Assurance
SOP No.:
 
Area:
Company wide
Page No.:
2 of 9
Effective Da
 
Revision No.:
00
Valid Upto:Previous Revision Date Reason for Revision
--- --- New SOP
Subject
Procedure for Vendor Qualification and Approval
Prepared By Checked By Approved By
Quantity of sample required.5.1.1.2 Purchase Department on receipt of Purchase requisition shall identify the vendor forrequired material, and shall initiate Vendor assessment as per the following procedure5.1.1.2.1 Purchase Manager shall send vendor assessment cum registration form (Annex ure I), tothe proposed vendor.5.1.1.2.2 The filled up Questionnaire shall be sent by the vendor to Purchase Manager.5.1.1.2.3 The Questionnaire shall be sent to QA for technical evaluation.5.1.1.2.4 QA shall evaluate the Questionnaire based on the Evaluation Matrix (Annexure –II).5.1.1.2.5 If required Vendor audit shall be conducted to confirm/ affirmation of vendors Qualitysystem by the representatives from QA, If felt necessary.5.1.1.3 If the vendor qualifies and meets the requirement of cGMP based onQuestionnaire,Purchase Manager shall procure sufficient sample of the Material along with Certificate ofAnalysis, which shall be forwarded to Quality Control for technical evaluation.5.1.1.4 On receipt of sample, QC shall analyse the sample as per agreed specifications .5.1.1.5 If the sample meets the specification and the quality system of the vendor is found adequate, name of the vendor shall be considered for inclusion in approved vendor list.5.1.2
Vendors for Material used in Existing Products
 
5.1.2.1 Need for the additional vendorsarises due to following reasons :
 
STANDARD OPERATING PROCEDURE
 
Department:
Corporate Quality Assurance
SOP No.:
 
Area:
Company wide
Page No.:
3 of 9
Effective Da
 
Revision No.:
00
Valid Upto:Previous Revision Date Reason for Revision
--- --- New SOP
Subject
Procedure for Vendor Qualification and Approval
Prepared By Checked By Approved By
 
Inadequate supplies
 
Commercial aspects
 
Deterioration in quality
 
Improper supply
5.1.2.2 Purchase Manager shall send vendor assessment cum registration form (Annex ure I), tothe proposed vendor.5.1.2.3 The filled up Questionnaire shall be sent by the vendor to Purchase Manager.5.1.2.4 The Questionnaire shall be sent to QA for technical evaluation.5.1.2.5 QA shall evaluate the Questionnaire based on the Evaluation Matrix (Annexure –II).5.1.2.6 If required Vendor audit shall be conducted to confirm/ affirmation of vendors Qualitysystem by the representatives from QA, If felt necessary.5.1.2.7 If the vendor qualifies and meets the requirement of cGMP based on Questionnaire,Purchase Manager shall procure sufficient sample of the Material along with Certificate ofAnalysis, which shall be forwarded to Quality Control for technical evaluation.5.1.2.8 On receipt of sample, QC shall analyse the sample as per agreed specifications .5.1.2.9 If the sample meets the specification and the quality system of the vendor is found

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