Vendor Qualification KSM - QI Score

Vendor Rating / Quality Index Score (QIS) :

Trend analysis data shall be compiled on annual basis for all the Key starting material and critical raw material. Assessment of trend analysis shall determine the performance of the supplier to remain in the ‘Approved”.

The performance rating (trending) of the supplier in the “Approved ” shall be done by assigning scores as follows:

Assign a score of “100” for every approved supply in year.

Assign a score of “0” for every rejected supply in year.
Assign a score of “50” for every approved supply but an adverse remark such as damage in packing, improper labels etc.

The vendor shall remain “Approved” for next year if the QI Score achieved More than 70.

The vendor rating is calculated based on following formula and example:

Example: 

A vendor supplied total 15 batches through out the year, among of them 10 batches are approved, 2 batches are approved with adverse remark and remaining 3 batches are rejected. The QI Score is calculating as follow:

QI Score / Vendor Rating: [(n x 100) + (n1 x 50) + (n2 x 0)] / total nos. of batches supplied in year

Where,

n = Nos. of approved batches supplied in year
n1 = Nos. of approved batches supplied in year with adverse remark
n2 = Nos. of batches rejected in year
 

                        (10 x 100) + (2 x 50) + (3 x 0)

QI Score: -------------------------------------------------   = 73.33

                                              15

QI Score is more then 70, hence vendor shall remain as approved for next year.

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.

Vendor Qualification KSM

Why vendor qualification is required?

 The vendor qualification is required to evaluate the quality of in-put materials for an API and Intermediates. Also it’s required to evaluate the quality system and manufacturing process of materials which to be supply for manufacturing of API and Intermediates.