VENDOR QUALIFICATION

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1.    PURPOSE:

To lay down the procedure for selecting, assessing and qualifying the vendor.

2.    SCOPE:

• This procedure defines the process of selection and evaluation of new suppliers/vendor or sub contractor supplying materials (chemicals, reagents, consumables etc.) and critical services (such as calibration, validation, logistics etc.). The procedure is applicable for new or existing supplier/vendor or sub contracting supplying materials or services.
• The procedure does not apply for vendor of capital equipments, projects, non critical consumables or other non-inventory parts or services.

3.    RESPONSIBILITY:

• It is responsibility of all the employees to ensure request for vendor evaluation are initiated in accordance with this SOP and no new/ alternative vendor will be introduced without formal written approval.
• It is the responsibility of Head Purchase or his designee to perform Financial and Commercial Assessment of the vendor.
• It is responsibility of the QA Department to test the assessment samples and generate assessment report based on results.
• It is responsibility of Head QA to oversee Technical and Commercial Assessment of vendor and its qualification.
• It is the responsibility of QA Department to maintain the updated list of qualified vendors and vendors.

4.    DEFINITIONS:

• Vendor: The term vendor includes the manufacturer and / or supplier of different materials and service providers.
• Service Provider: The agencies/ companies which provide services to the organization pertaining to technical as well as non- technical aspects.
• Critical Material: Any raw material which forms a part of/appears in a bulk vaccine or  final vaccine and packaging which comes in direct contact of bulk vaccine or final vaccine e.g. formulation excipients, container closures used for packaging/storage etc.
• Other Material: Any raw material/packaging material which is not classified as critical material.

5.    MATERIALS AND EQUIPMENTS:

Not applicable

6.    PROCEDURE:

6.1     For all the critical material and services, vendor shall be qualified through the process of      vendor assessment.

6.2     Preferably three and minimum two vendors shall be qualified for material and services.

6.3     Process of vendor qualification can be performed in two ways:

Vendor assessment for new vendors: A new vendors are qualified through this process.

Reassessment of old vendors: The vendors who are already providing critical material and services can be qualified based on assessment of retrospective data showing good history of supply.

6.3.1 Vendor assessment of the new vendors:

6.3.1.1.       Request to perform a quality evaluation of a potential vendor can be requested by any department.

6.3.1.2.       It is responsibility of the requester to ensure that issues of cost, quantity, logistic and quality commitment by the supplier/vendor are addressed before proposing the inclusion/change.

6.3.1.3.       Once the vendor is proposed for material or services, QA shall ensure that vendor of critical material supply or services shall be qualified following below given procedure.

6.3.1.4.       The process of vendor assessment is performed in following steps:

·          Financial & Commercial

·          Technical & Quality Assessment

·          Assessment samples and testing

·          Vendor Credentials and Vendor Audit

6.3.1.5                  Financial & Commercial and Technical and Quality Assessment is done through a questionnaire, ‘vendor assessment cum registration (VAR) form’ (Annexure 1).

  A.   Financial & Commercial Assessment:

i.             Purchase department sends the questionnaire (VAR) form to vendor.

ii.           Filled VAR form (by vendor) is received by the purchase department.

iii.          Purchase Department in coordination with Finance Department performs the Financial and Commercial Assessment of the Vendor.

iv.          For Financial and Commercial Assessment of the Vendor following points shall be considered:

·          Are other items supplied by the vendor and history of supplies if any?

·          Cost comparison /Procurement aspects

·          Cost Management (Cost visibility)

·          Presence in Low Cost Countries (Emerging markets)

·          Ability to achieve the target price

·          Sales tax or other information of compliance nature    

·          Financial status and financial statements

·          Sales volume

·          Assurance of Supply

·          Logistics and deliveries in time

·          Use of sub contractors

·          Communication capabilities & responsiveness

·          Quality & Regulatory compliance

·          Technical/Innovation

v.            Purchase department can also attach supporting documents, if any, used in assessment of the vendor to the VAR Form.

vi.          Base on evaluation Purchase department shall give their approval or non approval for vendor selection on the VAR Form.

vii.         Purchase department sends the assessment documents, i.e., Filled VAR, Financial and Commercial Assessment Report and supporting documents, if any, to QA Department for Technical & Quality Assessment.

  B.    Technical and Quality Assessment:

i.             QA department evaluates the Filled VAR form and supporting documents, if any.

ii.           For Technical and Quality Assessment of the Vendor following points shall be considered:

Quality Aspects:

·          cGMP Compliance & regulatory track record

·          Recalls & Complaints

·          Change/Deviation Management

·          Materials management controls

·          Quality Management Systems

·          Quality Agreement

·          Quality Culture

·          Production Facilities & Equipment

·          Product Quality Review

·          Process Validation approach:

·          QOTIF % (On time in Full)

·          Documentation standard

Technology specialism:

·          Plant capabilities

·          Laboratory capabilities

·          Business problems resolving capabilities

·          Technical skills/ Staff Qualifications

·          Control systems

·          Development capability

·          Process development expertise

·          Project management

·          Willingness to innovate

·          Intellectual property

Specifications:

·          Manufacturing/packaging/labeling details

·          Materials Safety Data Sheets

·          Logistic information (lead time to produce, delivery time, etc)

·          Certificates regarding Quality system, residual solvents, etc.

·          BSE/TSE evaluation

Analytical test method

Safety/Health/Environmental Risk

iii.          If the evaluation from the Filled Based Filled VAR Form and supporting documents is not conclusive, QA Department may request other quality related documents for review.

iv.          Base on evaluation QA Department shall give their approval or non approval for vendor selection on the VAR Form (APPROVAL).

  C.   Assessment samples and testing:

i.             In case of critical material such as packaging material, starting materials, intermediates etc. it is necessary to test the vendor samples before qualifying the vendor.

ii.           In such cases QA department shall request assessment samples of the material to be supplied and get them tested in house of by third party.

iii.          The sample quantity shall be sufficient for at-least one complete testing as per approved in-house or pharmacopeia specifications or shall be statistically relevant (for container closure system) for a trial run.

iv.          Assessment samples are labeled and sent for QC Analysis.

v.            QC Department performs all the tests as per given in-house specification or relevant pharmacopeia.

vi.          The results obtained are compared against the current specification and results typically obtained for the material in question.

vii.         Results of the QC testing must be documented including recommendation for acceptance or rejection of the supplier.

viii.       In case the test samples fails to meet the required specification the results may be communicated to the vendor for investigation and rectification of the failure. Re-sampling shall be considered on case to case basis.

ix.          I case the tested samples meet the specification and all other evidence assures the quality of the supplied product as well as quality management system of the supplier QA department may qualify the Vendor (APPROVAL).

  D.   Vendor Credentials and Vendor Audit

i.             Vendor Qualification is not necessarily done by audit although it is preferred.

ii.           Vendor can also be qualified based on the assessment of the third party accreditation such as ISO 9000:2008 (from certifying bodies such as TUV SUD, DNB etc), WHO GMP, FDA, TGA, NABL or other relevant certification and regulatory bodies.

iii.          In case vendor audit is considered necessary, QA Department shall initiate a full on-site audit of the proposed supplier to obtain more detailed information on the supplier’s quality systems, physical capabilities, etc.

iv.          The audit can be performed based on the checklist (Annexure 2) however it shall not be limited to it. If needed, additional observation pages can be attached to the checklist.

v.            In some cases QA may initiate a document audit or arrange for third party audit by a certified agency.

vi.          On completion of the audit an audit report shall be prepared. This report shall form the basis on which the vendor is qualified and its name incorporated in the approved vendor list.

Note: It is recommended to fully evaluate the first thee deliveries from a new supplier for compliance with established procedures and specifications.  If the initial deliveries comply with all requirements, the supplier can then be assigned as follows:

Approved Vendor -   Consistently meets or exceeds quality, cost and delivery requirements.  Q.C. testing frequency can be reduced to a level, which provides appropriate confidence in supply quality.

Conditional Vendor - No satisfactory trend of meeting quality, cost and delivery requirements established. This vendor can only be used in extreme circumstances and an alternative vendor should be actively sought.  No reduced Q.C. testing schemes apply to deliveries from this vendor.

6.3.2 Periodic assessment and Performance Control of the vendors:  

             i.        For critical materials/ services, vendor’s performance is reviewed annually once to ensure their continued ability to provide material and services that meet specified requirements on the basis of Quality, Time & Cost attributes, number of deliveries, degree of rejects, number and extent of problems encountered in production, stability data showing untoward trends attributed to material deficiencies or changes.

           ii.        Periodic assessment is performed through Periodic assessment form (Annexure 3).

          iii.        Feedbacks from all the concerned departments such as production, warehouse, purchase, Quality Control shall be taken through periodic assessment form. Extra sheets can be used to include information not captured in the periodic assessment form.

          iv.        The periodic assessment form shall be attached in vendor file.

            v.        Vendor Assessment cum Registration form shall also be sent to the approved vendor at least once in three years to get the updates about the quality system, financials & credentials of vendor.

          vi.        In case of major change in Quality system of vendor is observed through VAR or thorough change control intimation, a site visit shall be performed to judge the implication of the proposed change on quality of the product.

         vii.        A vendor shall be disqualified if any quality problem is observed in the Delivery or Product/Service Quality. In such cases process of vendor assessment shall be initiated. The criteria for vendor disqualification and subsequent assessment are as follows:

a.    Rejections of three successive consignments obtained from the approved vendor, shall render the vendor disqualified for that material and in such case, site audit/visit (as appropriate) followed by assessment of the vendor shall be performed.

b.   For raw materials not more than 10% rejection in terms of number of consignments received shall be permitted.

c.    For packing materials not more than 15% rejection in terms of number of consignments shall be permitted.

d.   For service providers……….

6.4     Documentation:

i.      Document Numbering: Each Vendor Assessment process shall be                             assigned a specific number by QA Department as per format “VQ-ABC-M/S-YYYY”, where

                VQ - represents Vendor Qualification.

                   ABC - Vendor name or Vendor Code

M - Raw material, Packing/packaging material, Consumables, Equipments/Instruments (plant machinery)  

              or

                   S - Service provider, and    

YYYY - represents the year in which the vendor was qualified.

ii.       Vendor File:  Each vendor file shall contain the following:

·         Vendor Assessment cum registration form.

·         Vendor documents based on which the assessment was performed.

·         Test Reports.

·         Vendor Site Audit Report.

·         Copy of Vendor certifications and licenses, if available.

·         Change control communicated by the vendor.

·         Vendor Reassessment Form.

          Periodic updates captured in vendor assessment form after every three years.

iii.      List of Qualified Vendors:

QA department shall maintain a list of Qualified Vendors (Annexure 4).

List of Qualified Vendors shall be updated when new vendor is qualified or an old vendor is discontinued.

7.    ANNEXURE:

Annexure 1: Vendor Assessment cum Registration (VAR) form

Annexure 2: Vendor Qualification Report & Approval

Annexure 3: Vendor Audit Checklist and Report

Annexure 4: Periodic Assessment form

Annexure 5: Qualified Vendor List