SOP FOR VENDOR QUALIFICATION

I.          PURPOSE

To define a Standard Operating Procedure for the approval of vendors supplying raw material and packing material.

II.        SCOPE

This procedure is applicable for purchase, quality assurance, quality control, production, and warehouse departments of all units.

III.       RESPONSIBILITY

Purchase department and PRD department is responsible to identify the vendor.

Quality Control department is responsible for the analysis of the vendor samples.

Quality Assurance department is responsible to audit and qualify the vendor.

IV.       ACCOUNTABILITY

Head-QA

V.        PROCEDURE

1.0        All incoming raw materials and packing materials should be tested as per STP and             approved as per specifications.

2.0       The Manufacturer and vendor should be evaluated for all incoming raw material and         packing material.

3.0              Raw materials should be classified into two categories, namely starting materials and               other raw materials.

3.1              Starting Materials :

3.1.1    Starting material is that which is

            3.1.1.1  Incorporated as a significant structural fragment of the API                           / Drug Intermediate.

3.1.1.2      Having significant effect on the Quality and Yield of the product.

3.1.2      Starting materials should be identified in TDP.

3.2       Other raw materials:

3.2.1    Other materials should be defined as that which is a commonly available

 chemical / solvent / catalyst / reagent etc.

           4.0       Packing materials are classified into Primary and Secondary Packing Materials.

4.1        Primary Packing Materials

4.1.1    Packing materials, which come in direct contact with the API /

  Intermediates are considered as Primary Packing Materials.

4.2         Secondary Packing Materials

4.2.1    All packing materials other than primary packing materials are to be            considered as Secondary Packing Materials.

5.0       Vendor Qualification for Starting Materials

5.1           Vendors for the starting materials should be developed at R&D during ‘Process       Development’ and ‘Laboratory Validation’.

5.2           R&D should provide relevant details to plant QA.

5.3           Purchase dept should send the ‘Vendor qualification questionnaire’

              Format No.: F01/SOPQA016-00, to vendor and request for  ‘Technical Data                        Package’.

5.3.1        TDP (Technical data Package) should contain the following data

-                      Brief manufacturing process

-                      Solvents used in the manufacture

-                      Impurity profile

-                      Working standard profile

-                      Characterization data

-                      Specifications and test procedures of the supplier

-                      TSE / BSE free Certificate

-                      Stability studies/ Hold time data

-                      Storage conditions

-                      Packing details

-                      MSDS

-                      Certificate Of Analysis (COA)

-                      DMF Number (if any)

5.4        After receipt, Purchase department should forward details to respective plant QA.

5.5        Incase of hazardous material, COA and commitment letter for adherence of   

           quality from the vendor, may be accepted in lieu of vendor qualification samples.

5.6       Quality assurance should approve / reject the vendor based on the data given in 

            the ‘Technical Data Package’(TDP) and  ‘Vendor qualification questionnaire’.

5.7         QA Dept should update the ‘Approved vendor list’

             Format No.: F03/SOPQA016-00 and communicate to Purchase and Warehouse     

                                     departments.

6.0        New Vendors / Alternate Vendors for starting materials of an existing process             should be developed as given below:

6.1              Purchase department should forward filled vendor questionnaire, TDP and representative samples from three distinct manufacturing lots to plant QA for evaluation.

6.2              Quality Assurance should forward the vendor samples to Quality Control department along with the “Vendor Sample Qualification Request Cum Report”

            Format No.: F02/SOPQA016-00.

6.3              If the samples conform to specifications, Quality Assurance department should forward the samples to Process Development/R&D department for performing lab / plant trials.

6.4              Process Development department / R&D should conduct at least one successful experiment / trial batch and submit the API samples for testing to QC.

6.5              After completion of analysis, Production department should compile and submit the data to QA the following data:

-                Batch processing data,

-                Stage wise yield data,

-                IPQC data and

-                Quality data of API.

6.6              Quality Assurance department should review the vendor qualification questionnaire, TDP, Quality Control analysis reports of vendor samples and performance experiments to approve/reject the new vendor.

6.7              QA Dept should update the approved vendor list and communicate to purchase and ware house.

6.8              One batch should be charged for Accelerated stability and Controlled Room Temperature stability to evaluate the impact of this change.

6.9              Vendor Qualification for other raw materials

6.9.1                 Purchase department should provide filled ‘Vendor qualification questionnaire’ to QA, before shipment of any material.

6.9.2                 If the first three consignments of the material from the vendor are approved as per specifications, the vendor should be approved.

6.9.3                 The approved vendor list should be updated by QA and this should be communicated to Purchase and Warehouse departments.

6.9.4                 Unless the specifications of the material differs between units, vendors of common chemicals, reagents and solvents should be approved across all API manufacturing locations.

6.10          Vendor Qualification for primary packing materials:

6.10.1                 On receipt of filled questionnaire, food grade certification, 21CFR compliance certification and representative samples (three distinct manufacturing lots) from the vendor, purchase dept should forward to plant QA.

6.10.2                 Quality Assurance should forward the vendor samples to Quality Control department with the “Vendor Sample Qualification Request Cum Report”.

6.10.3                 After completion of analysis, Quality Assurance should review the ‘Vendor qualification questionnaire’, QC analysis reports and approve / reject the new vendor.

6.10.4                     QA Dept should update the approved vendor list and it should be communicated to purchase and warehouse departments.

6.10.5                     The vendor should be approved across all API manufacturing locations, provided the specifications for the primary packing material is the same between units.

6.11          Vendor Qualification for Secondary Packing Materials

6.11.1             Purchase department should provide filled ‘Vendor qualification questionnaire’ to QA, before shipment of any material.

6.11.2             If the first three consignments of the material from the vendor are approved as per specifications, the vendor should be approved.

6.11.3             The approved vendor list should be updated by QA and this should be communicated to Purchase and Warehouse departments.

6.12          Inter Unit transfers

6.12.1          If the raw materials are received   through Inter Unit Transfers, they 

                should be analyzed as per in house specifications and approved.

6.12.2      Information of the original vendor and manufacturer should be provided                by  the supplying plant to the receiving plant.

6.12.3    In case of starting materials, the manufacturing plant should test and       

               release the material as per the customer plant / receiving plant                                  specifications and test procedures.

6.12.4       Plant QA should ensure the receipt of vendor certification details from     

              the source unit, before procuring/transfer of the material.

6.12.5      Vendors approved by one unit, should automatically be approved for      

              all units, provided material specifications are the same.

6.12.6      Receiving unit should obtain the vendor assessment data from the  

approving plant. Plant QA should evaluate the vendor assessment data                 

received from other plant, if required initiate laboratory scale batches or   

Pilot scale batches for starting materials.

6.13       Vendor Re-assessment

                                    6.13.1     Re-assessment of the approved vendors should be made once in a year                   for each raw / packing material.

6.13.2        The rejection rate should be evaluated for 30 batches of particular    

                material  from same vendor and manufacturer. Data from other                   units should  also be collected for this compilation of data.

6.13.3      If the approval rate is more than 90%, the vendor can be approved and  

              further reassessment is not required.

6.13.4      If the rejection rate is more than 10%, QA should audit the vendor  

              assessing the reasons for inconsistency in supplies. In case of a non-                       assignable cause, the vendor should be rejected.

6.13.5     If required, this assessment may be made prior to the compilation of 30  

              batches data based on supplies received.

6.13.6     Plant QA Dept should update the approved vendor list accordingly and 

             communicate to purchase and ware house departments.

7.0              List of Formats

Format No.	Title
F01/SOPQA016-00	Vendor Qualification Questionnaire
F02/SOPQA016-00	Vendor Sample Qualification Request cum Report
F03/SOPQA016-00	Approved Vendor List

VI.    REVISION SUMMARY

Version No.	Revised On	Reason for Revision
NA	NA	NA

END OF THE DOCUMENT