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Vendor Qualification Flow Chart

Manufacture of Medicinal Products and the Active Pharmaceutical Ingredients (APIs) used as starting materials in the production of these products is subject to strict good manufacturing practice regulations that are designed to ensure their quality, safety and efficacy. This ensures that patients worldwide and at any time can have confidence in the quality, safety and efficacy of medicines. The cGMP regulations for final medicinal products are clearly

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Ganesh V Gaonkar
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100% found this document useful (1 vote)
2K views1 page

Vendor Qualification Flow Chart

Manufacture of Medicinal Products and the Active Pharmaceutical Ingredients (APIs) used as starting materials in the production of these products is subject to strict good manufacturing practice regulations that are designed to ensure their quality, safety and efficacy. This ensures that patients worldwide and at any time can have confidence in the quality, safety and efficacy of medicines. The cGMP regulations for final medicinal products are clearly

Uploaded by

Ganesh V Gaonkar
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.

Vendor Qualification

Identification of Vendor

Material code generation

Consumable
RAW Material Packing Material

Classification Classification Classification

Critical Non Critical Critical Non Critical Critical Non Critical

Vendor questionaries Vendor questionaries Vendor questionaries Vendor questionaries Vendor questionaries Vendor questionaries

Review of filled vendor Review of filled vendor Review of filled vendor Review of filled vendor Review of filled vendor
Review of filled vendor
questionaries questionaries questionaries questionaries questionaries
questionaries

Material of construction Based on vendor


Procurement of 3 lot Procurement of 3 lot Procurement of 3 lot QC release based on and technical package certification and availablity
sample sample sample vendor CoA shall be evaluatedd of document,vendor shall be
qualified

QC testing and release QC testing and release Based on vendor


based on approved QC release based on based on approved Verification of results by certification and availablity Compliance
specification vendor CoA specification QA of document,vendor shall be
qualified

Verification of results by Verification of results by Verification of results by Compliance Compliance Inclusion in provisional
QA QA QA vendor list

Compliance Inclusion in provisional Inclusion in provisional Vendor Audit


Compliance Compliance vendor list vendor list

Inclusion in provisional Inclusion in provisional Inclusion in provisional Vendor Audit Vendor Audit Technical agreement
vendor list vendor list vendor list

Vendor Audit Vendor Audit Vendor Audit Technical agreement Technical agreement Approved vendor list

Technical agreement Technical agreement Technical agreement Approved vendor list Approved vendor list

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