Vendor Qualification For Raw Materials And Packing Materials

1.0    PURPOSE

1.1    To lay down the procedure for Vendor Qualification for Raw materials and Packing materials.

2.0    SCOPE

2.1    This procedure is applicable in Purchase, Quality Assurance, Quality Control and Warehouse departments.

3.0    RESPONSIBILITY

3.1    Head – Purchase

3.2    Dy. Manager - Quality Assurance

3.3    Head – Quality Control

4.0    ACCOUNTABILITY

4.1    Head - Quality Assurance & Regulatory affairs 
    
5.0    PROCEDURE

5.1    Vendor Qualification shall be done for all Raw materials and Packing materials.

5.2    Classification of Materials: 

5.2.1    Raw materials are divided into Critical and Non Critical Raw materials.

5.2.2    Critical Raw Materials are defined as follows:

5.2.2.1    Those that are incorporated as significant structured fragment of the API.

5.2.2.2    Those, which have significant effect on Quality or Yield of the process.

5.2.3    Other materials (such as Reagents, Chemicals, Solvents etc.) used in the API manufacturing process are considered as Non Critical Raw materials.  

5.2.4    Packing materials are divided into Primary and Secondary packing materials.

5.2.5    Packing material (s), which directly come in contact with the API are considered as Primary Packing material (s). 

5.2.6    Packing materials, which do not come in contact with the API are considered as Secondary Packing materials.

5.3    Research and Development shall forward list of Raw materials required for an API manufacturing process to Quality Assurance department.

5.4    Quality Assurance shall verify the raw materials with existing Approved Vendor List and identify the material(s) required for Vendor Qualification.

5.5    Vendor Qualification for Critical Raw materials / Primary Packing materials:

5.5.1    Quality Assurance shall forward the List of Critical Raw materials to Purchase department along with Vendor Questionnaires as per format No. xxxxx 

5.5.2    The Purchase department shall forward the Vendor questionnaire to the Vendor and request for 3 samples from different production batches for complete analysis.

5.5.3    The Vendor samples shall be analysed at Quality Control / Research and Development and the status shall be communicated to Quality Assurance Department.

5.5.4    Purchase department shall forward the duly filled Vendor questionnaire to Quality Assurance department.

5.5.5    Quality Assurance department shall coordinate with the Purchase department to get the additional information / data from the vendor, if any.

5.5.6    Quality Assurance department shall review the analytical reports and the Vendor Questionnaire.

5.5.7    Quality Assurance and Purchase department shall audit the Vendor manufacturing facility to evaluate the Vendors capabilities and Quality system.

5.5.8    Quality Assurance department shall Approve / Reject the Vendor based on the Audit findings.

5.5.9    Vendor audit shall not be performed, incase the vendor has any regulatory approval (s) for the subject material.

5.6    Vendor Qualification for Non Critical Raw materials / Secondary Packing materials:

5.6.1    Quality Assurance department shall forward the List of Non Critical Raw materials used in the API to Purchase department.
5.6.2    Purchase department shall request the Vendor for one sample from production batches for complete analysis.

5.6.3    The Vendor samples shall be analysed at Quality Control / Research and Development and the status shall be communicated to Quality Assurance department. 

5.6.4    Quality Assurance department shall review the analytical results and Approve / Reject the Vendor and shall communicate to Purchase and Warehouse departments. 

5.7    Alternate Vendor development for Critical Raw materials and Primary Packing materials 

5.7.1    Follow the procedure from 5.5.1 to 5.5.7.

5.7.2    Quality Assurance department shall request Research and Development / Process development department to take three laboratory trial batches using the material from the subject Vendor.

5.7.3    The output shall be tested as per laid down procedures. If the output meets the specifications, 3 months accelerated stability shall be carried out for the second laboratory trial batch.

5.7.4    On successful completion of 3 months accelerated stability, Quality Assurance shall approve the Vendor and shall communicate the Purchase and Warehouse departments. 

5.8    Quality Assurance department shall update the Approved Vendor List periodically as per format Noxxxxx

5.9    A copy of the current Approved Vendor List shall be circulated to Purchase and Warehouse departments for its implementation.

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Packing materials, vendor qualification, quality assurance