SOP FOR Vendor Qualification



To lay down the Procedure for Vendor Qualification &for Vendors.

  • SCOPE:

This Procedure is applicable for qualifying the vendors for all the raw material and packing materials


Officer QA shall be responsible for the procedure mentioned in this SOP.


Head QA shall be accountable for the implementation of this SOP.


Vendor registration Form                                      -Attachment-I

Vendor audit and development form                      -Attachment-II

Vendor Quality Audit Checklist                             -Attachment-III

Vendor assessment and approval Checklist           -Attachment-IV

Approved Vendor list Raw/Packing material        -Attachment-V

Vendor Quality Agreement                                            -Attachment-VI



6.1.1 Head QA / His designee

6.1.2 Manager QC / His designee

6.1.3 Manager Purchase / His designee

6.1.4 Head Production / His designee, as appropriate

    • Based on the reputation quality standards and marketing trend analysis, Purchase Department shall initiate to make a vendor list for material.
    • Purchase department shall send copy of specifications/other requirement (as applicable) to the vendor.
    • After receiving the feedback from vendor on capability of supplying the required quality material, ask for quotation.
    • Once the initial commercial terms are satisfied /agreed by the company and vendor, request shall be done for samples along with Certificate of Analysis COAs.
    • QC Manager shall assess the quality of the samples and review the vendor COAs and give feedback to Head-Quality Assurance.
    • QA Head shall communicate the results of sample analysis along with recommendations to purchase department who communicate the same to vendor.
    • Additional sample, if required, shall be received and assessed for quality.
    • Once the sample meets the requirements, QA Head discussed with Purchase department and starts the vendor approval process.
    • Vendor Qualification shall be perform through Vendor Questionnaires.
    • QA send the Vendor Audit/Evaluation Questionnaire as per Attachments I, II and III to Vendor and Vendor Fill the Questionnaire and send back to QA with required Supporting Documents.
    • QA evaluate the Vendor filled Questionnaire and supporting documents
  • Head Quality Assurance shall approve the vendor based on the following parameter.
    • Vendor’s facility and documents shall be compliance with Good Manufacturing Practice (GMP).
    • Sample compliance to specifications.
    • Delivery schedule/other commercial terms agreeable.
    • Update the approved vendor list and maintained in QA and distribute the copies to stores,QC etc. as applicable.
    • If any discrepancy observed during vendor evaluation through Questionnaires, QA Head can plan for Vendor Physical Audit.
    • Vendor Physical Audit shall be performed through Questionnaire of Checklist for manufacturers/suppliers audit for Raw/Packing Materials as per attachments – I, II and III as per format no.
    • Purchase Department to coordinate and plan for vendor audit schedule in consultation with QA/QC/Production department heads and confirm the same
    • Vendor audit teams conduct the vendor audit to assess the Good Manufacturing Practice (GMP) and other quality system standards of the vendor’s facility.
    • During the audit impress upon the vendor the importance of GMP, quality and other tests desired by the company with the respect to their quality policies.
    • During the audit educate the vendor, if required, on GMP, product specifications, quality standards etc.
  • Head Quality Assurance shall approve the vendor based on the following parameter.
    • Compliance of vendor’s facility to Good Manufacturing Practice (GMP) standards.
    • Sample compliance to specifications.
    • Delivery schedule/other commercial terms agreeable.
    • Update the approved vendor list maintained in QA and distribute the copies to stores, etc. as applicable.
    • Plan for periodic vendor audit in view with following.
    • In case of frequent quality problems.
    • In case of any major modifications in vendor’s facility.
    • As per routine Quality Assurance plan.


    • In case of multiple vendors for one material, after the successful completion of the vendor audit/Evaluation the rating is given by Head Quality Assurance based on the following.
    • Vendor’s GMP Compliance/Quality System standards.
    • Performance with respect to quality delivery schedule during supply.
    • of non-conformance in supply (if any).
    • Grading are given I, II & III (Chronologically) viz., I indicating “Best & Preferable”, II indicating “Ideal and equally preferable”, III indicating “Qualified and Acceptable”.
    • In case of continues rejection of material two times within a supply of 3 consignments, the vendor shall be blacklisted. Similarly more than 4 rejections within a year shall be considered for blacklisting the particular vendor.
    • In such cases re-qualification of the vendor requires approval from Head- Quality Assurance, subject to management authorization.
    • Procedure for preapproval/ provisional approval of existing vendor.
  • Purchase Department in consultation with QA/QC Head to decide the vendor pre-approval based on the following.
    • Reputation of the vendor.
    • Vendor’s agreement to supply material meeting the “Specification”
    • Review of vendor COAs.
  • Other related commercial terms.
    • Insist a “sample” in case the requirement is felt before supplying the consignment (it is merely based on the individual material, category and based on the assessment of technical competence of the vendor).
    • Insist COAs along with supply of material.
    • Test and inspect the quality of material by following 100% identification (for Active Pharmaceutical ingredients and Excipients) and testing of all quality parameters.
    • Manager Quality Control shall communicate the results of quality testing of material to Quality Assurance department.
    • Head Quality Assurance shall assess the quality test results and based on this to consider the provisional/pre-approval of the vendor for further supply. Accordingly update the approved vendor list and indicate the provisional approval status.
  • The following parameters shall be considered significant for the provisional approval/pre-approval of vendor (Applicable only to supplier of excipients and other non printed packing materials).
    • Continuous supply of consignments meeting the Specified requirements.
    • GMP Certificate of the vendor’s facility/other quality Accreditations like ISO certification etc.
    • Document the approval status of the vendor as per Format No. SOP/QA/015/F04-00.
  • Frequency of vendor audit
    • Routine vendor audit will be conducted once (minimumin 5 years).

           Note 1:Head-QA shall initiate change control for the change of existing vendor or other alternative vendor in accordance with SOP No- SOP/QA/003, Procedure for Change Control.

Note 2: Change in the vendor shall not be applicable to the countries where commitment of specific vendor has been made. In such case prior approval of the respective regulatory agencies/license holder shall be obtained before change of vendor




QA   –            Quality Assurance

SOP –            Standard Operating Procedure


Quality Assurance

Quality Control





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