Qualification of Vendor for raw material in Pharma:

In pharmaceutical for purchase of raw material mainly starting raw material you have to approve the vendor.

In following circumstance need to develop the vendor:
-      When new product is developed (For new raw material)
-      As a alternative of source of the existing  raw material
-      Supply of existing vendor is not satisfactory
-      New raw material from existing raw material.

Following the procedure to qualification of new vendor:
Based on the Vendor questionnaire
Based on the R and D trial and QC analysis result
Based on Vendor Audit

Based on the Vendor questionnaire:
-        Purchase department shall identify the vendor
-        After identify the they send the vendor questionnaire
-      Along with vendor questionnaire, TSE / BSE declaration, GMO, declaration free from volatile impurities,  OVI declaration shall be provided by the  vendor
-      QA department evaluate the all the received documents.
-      Based on the evaluation of the documents they  procure the three samples.

Based on the R and D trial and QC analysis result
-        Purchase department identify the vendor and send the required specification to the vendor
-       Procure three samples from three different batches along with COA.
-      QC person shall analyze the samples as per the standard specification or the as per the requirement for the new product.
-      It samples pass in the specification, sample shall be released with COA by QC department.
-     After samples are released by QC, same shall be send to R & D for  trial if required.
-      Performance trial of these samples shall be taken in R & D and samples analysis report of trial batches results shall be recorded and submitted to QA.
-      Based on these data QA evaluate the sample
-     After successful evaluation & assessment vendor shall be qualified as approved vendor.

Based on Vendor Audit
-  Head-QA decide for conducting the audit of the facility of the manufacturer if required
-  Information about vendor audit shall be given in advance to the concern person of manufacturer/supplier in writing or through verbal communication along with Audit agenda if required.
-  Vendor audit shall be conducted by any authorized person including Designee QA or Head Operations or Head QA along with Designee purchase if required
-  During the vendor audit, auditors shall review the quality, manufacturing process, capabilities and commitment to prevent quality problems of the vendor
-   After conducting the audit report shall be prepared and it shall be shared to the vendor
-   Compliance report shall be provided by the vendor if required

      Based on the evaluation of the vendor finally approved vendor list shall be prepared.

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