Vendor Qualification KSM - API

Vendor qualification shall be done in following manner:

-          Based on vendor samples evaluation

-          Based on vendor samples performance or process simulation trial

-          Based on vendor audit

-          Based on provided filled questionnaire

-          Periodic vendor evaluation shall be done as based on vendor rating.

 

Vendor samples evaluation and performance trial: in general three vendor samples from the consecutive batches to be procured for desire material and analysis against the firm specification and method of analysis to confirm the quality.

 

After satisfactory comply of samples, performance trial will be taken for key starting material and produced API as per firm manufacturing process. This API shall be analysis against the firm API specification and it shall be kept in Accelerated stability as per ICH, to confirm the impurity profile and degradation at accelerated condition. If the stability comply satisfactory, then process package or vendor development report to be prepared for vendor.

 

Vendor audit: after satisfactory evaluation procured the filled vendor questionnaire and required documents from the vendor to evaluate the system to evaluate and study and documentation process are such as:

-          Certificate of vendor samples

-          Route of synthesis of material

-          Impurity profile

-          Solvent profile and declaration

-          GMO certificates

-          TSE / BSE Declaration

-          Process flow chart of manufacturing process

-          Specification and method of analysis of material

-          Organization chart

Based on satisfactory evaluation, vendor audit perform for assurance of quality system and process and vendor shall be approved. If the identified vendor holds a Drug Master File (DMF), ECOS or is having the product specific TGA, USFDA, MCA or any other international Regulatory approval, then based on the Vendor Questionnaire such vendors are approved directly.