SOP FOR Vendor Qualification

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  • OBJECTIVE:

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

  • RESPONSIBILITY:

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

  • ACCOUNTABILITY:

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

  • ATTACHMENTS:

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

6.0   PROCEDURE:

  • VENDOR AUDIT TEAM:

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

  • PROCEDURE FOR NEW VENDOR APPROVAL:
    • 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.

 

  • VENDOR RATING:
    • 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

7.0     REFERENCES:

In-house

8.0     ABBREVIATIONS

QA   –            Quality Assurance

SOP –            Standard Operating Procedure

9.0      DISTRIBUTION LIST:

Quality Assurance

Quality Control

Production

Warehouse

 

10.0HISTORYOF REVISION:

VersionNo. EffectiveDate Reason for Revision

 

           

 

 

 

 

 

 

 

 

SOPs