SOP For Vendor Management

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The manufacturer or supplier who is supplying the material in routine and registered for the supply of specific material after the approval process considered as an approved vendor. Vendor management consists of the Identification, Qualification, Requalification, management of changes at the vendor site, Vendor Audit, Technical Agreement, Deregistration Process, etc.

Vendor Management

  PURPOSE:

  • The objective of this Standard operating procedure (SOP) is to describe a standard for the management of Vendors to get consistent quality of Raw Materials, Primary, and Printed Packaging Materials.
    • This SOP comprises the concepts of:
    • Qualification of New Vendors
    • Qualification of Existing Vendor for New Material
    • Requalification of Vendors
    • Management of changes related to Vendor
    • Vendor Audit
    • Technical Agreement
    • De-registration Process
    • Evaluation of Supply for Quality (Q Score)
    • Annual Risk Assessment

       SCOPE:

  • This SOP is applicable for Management of Vendors of the following materials:
    • Raw Materials (API and Excipients) used in Drug Product Manufacturing.
    • Product-contact Packaging Materials (Primary Packaging Material).
    • Printed Packaging Materials, Packaging Material with other kinds of identification e.g. imprint or embossing.

PROCEDURE OF VENDOR MANAGEMENT:

  • It is a total quality management system that assures that materials procured from Vendors are manufactured, packaged, and shipped under a controlled process that results in consistent conformance to quality as per company quality system.
  • Vendor management shall consider based on a specific component, the active ingredient, container or closure type.
  • Qualification/deregistration of the vendor shall be specific for the site of manufacture of Vendor/material and not for the Vendor’s company as a whole.
  • The vendor may be the Manufacturer and/or Supplier, providing material from the aspecific site.
  • All deviations in the process of vendor management as per site-specific SOP shall mandatorily be approved by Site Quality Head.
  • The commercial department shall coordinate for potential Vendors from available resources and the Vendor management process shall be as described in this standard.
  • Manufacturers of API, KRM, Key Excipients and Primary, and PrintedPackaging Materials will be subjected to audits based on the outcome of the annual risk assessment or defined frequency which is earlier.
  • In general re-qualification of Manufacturers of API shall be carried out once in three years.
  • For Key Excipients, Key Raw Materials, and Primary and Printed PackagingMaterials re-qualification of Manufacturers shall be carried out once in five years.
  • Qualification of new vendors under vendor management:
  • Vendors shall be identified by Commercial in consultation with other departments such as Product Technology Development(PTD), Process Technology Transfer (PTT), Chemical Research Division (CRD), Product Development Research (PDR), etc., as applicable.
  • The identification of a new Vendor shall be based on the assessment of the Vendor’s capability to supply the material with consistent quality standards set by the company.
  • All new Vendors shall be verified whether they are Manufacturers Suppliers for a particular material. The following rules shall apply for Vendor qualification /vendor management:
    • When the Vendor is the Manufacturer and the Supplier, the Vendor shall be qualified as a single entity.
    • When the Vendor is a Supplier who is not a manufacturer and does not carry out any ’partial manufacturing’ activity, only the Manufacturer needs to be qualified by the company for all the applicable criteria based on the type of material procured.
    • The Vendor is a Supplier who is not a manufacturer but carries out a ‘partial manufacturing’ activity, Vendor Qualification will need to be carried out for both Supplier and Manufacturer.
    • In case of a change of manufacturing site by the Vendor, the qualification process shall be repeated.
    • In case where, there is change in manufacturer names because of merger or acquisition, and no change in quality, manufacturing site and service of products, the qualification process is not required to be repeated, however declaration from Vendor shall be mandatory and change in Vendor / Manufacturer name shall be intimated by Vendor Qualification Office to respective manufacturing sites through electronic or manual system as applicable.
  • Upon identification of a new Vendor, the following documents shall be requested by a commercial from the Vendor as a prerequisite:
  • Vendor Information Form (VIF) stating whether the vendor is Manufacturer / Supplier / Manufacturer andSupplier. This form shall be submitted by all active vendors, in case any changes occur at a later date, the same shall be communicated by the Vendor through a revised VIF for vendor management.
  • If the identified Vendor has a format for the self-assessment questionnaire, which meets company expectations, the same can be used in lieu of company Vendor Information Form.
  • TSE/BSE Risk Evaluation Questionnaire to be filled by the Vendor if the material under consideration is prepared from animal origin.
  • If the material is not from animal origin, a declaration from the Vendor regarding TSE/BSE risk-free material must be taken stating that the material is not produced from animal sources and
  • No material of animal origin is used in the manufacturing process of the same under vendor management.
  • If this assessment has already been done by any regulatory authority and certification is available (e.g. TSE certification by EDQM), a copy of this certification may be used in lieu of a questionnaire for TSE/BSE risk evaluation.
  • Vendor Qualification Office designee shall ensure the vendor mandate technical documents for its suitability, adequacy, and completeness as per the respective procedure.
  • Maintain the centralized vendor document database, vendor-site wise-molecule-wise through the electronic or manual system by Vendor Qualification Office designee.
  • Vendor Document Validity :

Table A: Documents Validity

Table-A-Vendor-Management
  • Vendor Technical documents required for the qualification of a new vendor are listed in Table B.Retention of Vendor Document / Reports.
  • The hard copies of vendor technical documents, audit reports and compliance reports along with evidence (as available) shall be retained for a period of06 years or one revision whichever is earlier.

Table B: Documents / Activities required for Qualification of New Vendor

Table-B-Vendor-Management


Notes:
Any other document necessary for Vendor Qualification, such as Food Grade Certificate, Melamine Free Certificate, Genotoxic Impurity Evaluation Report, Analytical Method Validation Reports, Moisture Vapor Transmission Rate (MVTR) Certificate, Benzophenone Declaration, etc. may be requested on case to case basis.

  • Materials procured from Internal Sites/ Affiliates, vendor qualification mandate documents based on the type of material under procurement shall be required as a part of the Vendor Qualification Process.
  • In all such cases, the Technical Agreement is required for Internal Sites under vendor management.
  • In case material procured from Third Party or Loan License manufacturing units, all qualification documents as per Table B and copy of Technical Agreement between the company and Third Party or Loan License Manufacturing Sites shall be obtained.
  • Commercial shall arrange for samples along with Vendor’s COA for testing and evaluation at site QC / Analytical Research (AR) Laboratories.
  • Additionally, qualified/validated method(s) of analysis, impurities, working standards, etc., as applicable and if needed, shall be arranged.
  • However, in case of materials that are hazardous in nature i.e. solvents and gases, they may be evaluated based on the review of Vendor’s COA vis-à-vis desired company specification along with the TSE/BSE Certificate received from the vendor.
  • Samples shall be analyzed by QC / AR or any other Qualified Laboratory as per In-house or Vendor’s method.
  • Materials procured from the Vendor for evaluation shall meet the desired specification (under vendor management).
  • The samples should be from the same manufacturing site and the same manufacturing process.
  • The minimum number of samples required for testing and evaluation shall be as per the following table (Table C):

Table C: Samples requirement for testing and evaluation

Table C - Vendor Management
  • Based on satisfactory data of complete analysis, R&D Development Batch data and Site Exhibit Batch data, material from Provisionally Approved Vendor can be used for Process Validation.
  • However, Site Quality Head to ensure the availability of audit reports prior to commercialization.
  • Based on satisfactory data of complete analysis and R&D Development Batch data, Material from the new vendors can be used for Exhibit Batch.
  • In case of a significant difference between Manufacturing Site results and Vendor’s COA, an investigation shall be done to find out the root cause and appropriate corrective action shall be taken.
  • Corrective action shall depend on the finding of investigations. Upon satisfactory investigation and corrective action, if needed, the Vendor may be asked to provide a fresh sample for evaluation.
  • The same test method(s) shall be used at Manufacturing Sites and Vendor end.
  • Test method(s) may be shared with the Vendor and mutually agreed by both the parties under a confidentiality agreement if needed.
  • Any subsequent changes in such test method(s) shall be shared with the Vendor.
  • The company may also decide to use methods developed and validated by the Vendor or monograph methods (in case of excipients).
  • In the case of API, KRM, KE, and Primary Packaging materials, if the sample complies as per the specification, trials for a feasibility study of the material may be taken by Product / Packaging / Process Development Laboratories, if warranted.
  • Products from batches used for material feasibility study trials should meet desired specifications for release. Such products also are placed understandability studies if needed as per Site-specific SOPs/ current regulatory guidance.
  • In order to establish the consistency of product within the container and among the containers as a prerequisite of vendor approval following the sampling plan shall be followed by Site Quality for minimum first two consignments:

Sampling Plan for Drug Substances (APIs):

Sampling-Plan-for-Drug-Substances-APIs


Note: For all consignments, regardless of the number of containers, the Identification test shall be performed on each container. “*” – Testing should be performed considering the criticality of parameter and as per specification.

Sampling plan for excipients:

Sampling-plan-for-excipients


Note: For all consignments, regardless of the number of containers, the Identification test shall be performed on each container. “*” – Testing should be performed considering the criticality of parameter and as per specification.

  • For further commercial consignment received, QC shall analyze the samples as per the site SOP on “Testing and Releasing of Raw Materials”.
  • Vendor Audit shall be performed after all the documents have been reviewed, sample evaluation completed and performance trials if any are satisfactorily completed but prior to commercialization of the product.
  • Conclusively, approval of New Vendors shall be based on the following (but not limited to):
    • Review of vendor qualification mandate documents as listed in Table B.
    • Review of sample evaluation results to review specification compliance and feasibility study in case warranted by R&D / PTD.
    • Based on review and assessment, Site Quality shall update the respective vendor status as per their Site-specific SOP in the electronic or manual system as applicable.
  • Electronically generated Approved Vendor lists shall have the following details:
  • Printed By (User ID)
  • Date of Print (System ID)
  • The approved Manufacturer(s) list shall contain (but not limited to): Material Description, Material Code, Manufacturer’s Name, Manufacturer’s Code, Address of Manufacturing Site and Validity of Approval.
  • In the case of a manual list, the site shall review annually at the beginning of the calendar year for any updates.
  • Site Quality is responsible to maintain the list and revision or version number of the Approved Vendor List.
  • Attache a duly approved addendum to the list in case new vendors are approved during the year.
  • Numbering System of Approved Vendor List:
  • QA shall assign the approved vendor list number as per the below-mentioned procedure.
  • Approved vendor list number shall be i.e. AA/AVL/XXX/YY.
  • The first two alphabets stand for the location code i.e.
  • AA              : Location code.
  • Followed by “/”, next three alphabets i.e. AVL stands for the approved vendor list.
  • Followed by “/”, next three alphabets i.e. XXX stands for item identification like API, PKM, and EXP. This code represents the item code as follows:
  • API             : Active Pharmaceutical Ingredient   
  • PKM           : Packing Material      
  • EXP            : Excipient
  • YY               : Represents the version number of the approved vendor list.
  • Qualification of existing vendor(s) for new material(s):
  • Procedures, as described above, shall be followed suitably for Qualification of Existing Vendor(s) for a New Material(s).
  • Documentation requirements for Qualification of Existing Vendor(s) for New Material(s) are as mentioned in Table D.

Table D: Documents / Activities required for Qualification of Existing Vendor for New Vendor

Table-D-Vendor-Management
  • Re-Qualification of the existing vendor(s):
  • Any other document necessary for Vendor Qualification, Such As Food Grade Certificate, Melamine Free Certificate, Genotoxic Impurity Evaluation Report, Analytical Method Validation Reports, Moisture Vapor Transmission Rate (MVTR) Certificate, Benzophenone Declaration, etc. may be requested on case to case basis.
  • Documents required for the Re-qualification of Vendors shall be as per the mandatory documents defined in Table B.
  • Audit requirement of manufacturing site of Vendor during the Requalification of existing Vendors for API, KRM, KE, Primary Packaging Materials and Printed Packaging Materials shall be based on Annual Risk Assessment provided by the Manufacturing Site.
  • However, preferably for API audit of the vendor shall be conducted once in three years and for KRM/ KE/Primary Packaging Materials and Printed Packaging Materials once in five years irrespective of Annual Risk Assessment.
  • Vendor Documents will remain valid as per the validity provided in Table A.
  • Management of changes related to the vendor – Vendor Management
  • Management of changes related to the vendor shall be governed by the site quality system and SOP of Change Control Management.
  • Vendor Audit Management:
  • Audit of Vendors of API, Primary Packaging Materials and Printed Packaging Materials shall be preferably done before taking up exhibit batches. But mandatorily before Commercial batches are manufactured using the Vendor’s material.
  • Vendor Qualification Office shall update the onsite audit request for new vendors based on information forwarded by Site Quality, Site R&D, or any other source as per Attachment I – Audit Request Form.
  • Vendor Qualification Office shall prepare the annual audit planner based on the Annual Risk Assessment received from the Sites, Audit Request Forms, and request from Regulatory Affairs and on the basis of requalification criteria for audit.
  • The vendor audit shall be conducted only after ensuring the availability of vendor code in the electronic system.
  • The Quarterly Audit schedule shall be prepared by the Vendor Qualification Office based on the confirmation of audit data received from the vendor through commercial.
  • For Active Pharmaceutical Ingredients (API) the audits shall be conducted at the frequency of three years from the last audit date.
  • For Primary Packaging Materials and Printed packaging materials, KRM and KE audit shall be conducted at the frequency of five years from the last audit date. However, a need-based audit can be triggered while introducing a new molecule.
  • Auditors preferably accompanied by a Commercial representative shall perform vendor’s quality systems audit. In the case of For Cause Audit, Site Representative shall conduct and/or accompany the lead auditor need-based.
  • The focus of the audit shall be the assessment of Vendor’s cGMP compliance level as per relevant Regulatory Guidelines like ICHQ7, EU GMP, and ISO 15378 Guideline, etc.
  • The auditor shall verify whether proper policies/procedures/process controls exist and are followed to assure the product’s SISPQ requirements.
  • During the audit, ensure the vendor’s capabilities for manufacturing, technical competency, and GMP systems. Based on the severity of audit findings, the vendor shall be categorized as “Approved”, “Not Approved” or “Under Observation”.
  • The audit report shall be prepared and forwarded to the commercial for distribution to the vendor within 30 calendar days.
  • Audit Report for API/KRM/KE/Primary Packaging Materials and Printed Packaging Materials shall be prepared covering applicable clauses of CGMP guidelines and can be modified as a need base.
  • Commercial to arrange for the response against the audit observation within 30 calendar days.
  • On a satisfactory review of the response, audit closure shall be issued for the respective vendor.
  • In the case of vendor categorized as “Under Observation” based on the audit, the audit report shall be shared with Site for risk assessment and mitigation plan as per Site-specific SOP.
  • Commercial shall review the status every month and further actions shall be executed to change the status of the vendor as approved or deregistration in the time frame, not more than 6 months.
  • Vendor Qualification Office designee shall maintain records for Audit and Compliance reports Vendor wise / Site wise / Date wise.
  • The current audit report and compliance report shall be considered as valid as per the timeline provided in Table A.
  • Vendor Qualification office is responsible for ensuring necessary action, for the vendors to whom warning letter/ Import alert/discontinuation of CEP or country-specific regulatory restriction for the supply of material, refer Attachment II.
  • In case of critical rejections related to material supplied by a vendor in one of the SPIL Site, Corporate Quality Compliance shall ensure all other Impacted Sites are notified for necessary actions.
  • Need base audit can be handled through the Group Audit/ Third Party Audit.
  • The audit report can be purchased from the third party after evaluating the adequacy of trained and qualified staff having knowledge of cGMP regulations for conducting the audit.
  • In the case of Vendors already existing in subsidiary companies, their Audit Reports may be accepted by the company/location based on the Existing Agreement / CDA between the company & affiliates.
  • Vendors may be qualified on the basis of the Paper Audit.
  • This may include evaluation of Vendor Technical Mandate or equivalent document, copy of cGMP (Current Good Manufacturing Practices)certificates issued by competent Regulatory Authority or Certification Agencies like ISO, etc. under one or more of the following circumstances:
    • Patent related issues.
    • Vendor’s company policy to restrict audit.
    • Confidentiality related issues.
    • Active substances are not true APIs.
  • However, in such cases, there should be clear specifications for the material being procured and this specification shall be agreed upon with the manufacturer.
  • Regulatory requirements of a market where the product is going to be supplied shall also be considered by the corporate Quality Audit for Audit Waiver.
  • Auditor Qualifications under Vendor Management :
  • Educational Qualifications: An Auditor shall have a minimum Bachelor’s Degree in the relevant Scientific /Technical Field.
  • Experience:
  • An Auditor shall have a minimum of 5 years of experience in the pharmaceutical industry (API or Drug Product) in the Quality Management Function with at least 2 years in the Quality Assurance role.
  • The auditor shall have specific knowledge and experience of the requirements of cGMP and must have participated in at least three GxP (as applicable) audits as Co-auditor.
  • Certification as a “Qualified Auditor” from an External Agency is preferable.
  • List of Qualified Auditors shall be reviewed for any addition or deletion of information once in a year or as and when required.
  • The detailed curriculum vitae (CV) which cover the Educational, Experience & Training related information shall be maintained & archived at Corporate Quality Audit Office along with Job Description (JD).
  • Qualified Auditor shall follow the Corporate Code of Conduct for audit.
  • The Technical Agreement under Vendor Management:
  • Technical Agreements shall be obtained from Vendors of APIs, Excipient, KRM, Primary Packaging Materials, and Printed Packaging Materials.
  • The agreement shall be printed on the company’s official  Letter Head.
  • Technical Agreement shall be entered with Vendors for API, KRM, KE, and Primary Packaging Materials and Printed Packaging Materials to ensure commitment for adhering to the applicable guidelines.
  • The technical agreement for API/KRM/Excipient shall include but not limited to the points listed in Attachment III-A and for PPM Attachment III B.
  • These formats are governed by Corporate SOP.
  • Changes in contents of the Technical Agreement shall be done with mutual consent between SPIL & Vendor and acceptable on Vendors Letter Head.
  • Technical Agreement shall be signed with the Vendor after successful completion of Audit for API and Primary Packaging Materials and Printed Packaging Materials as applicable.
  • Technical Agreement shall be obtained from Vendor for KRM and KE prior to commercial procurement.
  • The agreement shall be required if the material is manufactured and supplied by a company manufacturing site to another site.
  • Amendments related to products from an Approved Vendor may be incorporated in the Existing Technical Agreement with the Vendor by the Vendor Qualification Office.
  • Review and Approval of Technical Agreement with the Vendor shall be preferably managed centrally by Vendor Qualification Office.
  • The validity of the Technical Agreement is as mentioned in Table A and/or major change like manufacturing site change, senior management change whichever is earlier.
  • Handling the consignment(s) from a new vendor at the plant (Vendor Management):
  • On receiving of consignment from a new vendor, the warehouse shall check the vendor details against the approved vendor list.
  • If it is not available then the intimate Quality assurance department for Evaluation of Vendor and Metis entry after evaluation data share with FDD.
  • In the case of the manual list (For Vendor List), the site shall review annually at the beginning of the calendar year for any updates.
  • Site Quality is responsible to maintain the list and revision or version number of the Approved Vendor List. A duly approved addendum may be attached to the list in case new vendors are approved during the year.
  • After approval, QA shall subsequently update the details in the VQ Module.
  • Warehouse shall receive the consignment after QA Approval and shall prepare the good inward memo (GIM).
  • QC shall collect samples as per prevailing SOP on “Raw material sampling”.
  • While sampling, quality control/Warehouse shall check the integrity of containers, manufacturers’ seal and correspondence between the delivery note and the label. QC shall ensure that results are within the specification.
  • On receipt of the result of the analysis, QA shall comply with all documents. On finding satisfactory, QA shall issue an updated version of the “Approved Vendor List” and retrieve the earlier version.
  • Handling rejected consignment from the approved vendor (Vendor Management) :
  • In the case of rejected consignment from the approved vendor, Head quality shall send a “rejection note” to the commercial department and to Corporate Compliance.
  • The commercial department shall inform the vendor regarding the rejection of consignment.
  • In the case of two consecutive rejections of consignments, the vendor shall be kept under observation.
  • Head Quality shall evaluate the results and decide on the further course of action.
  • If require, Head Quality shall intimate Corporate Compliance to schedule for vendor’s site audit, to evaluate vendor’s understanding of the GMP requirements, Quality assurance systems and manufacturing condition and control on the process.
  • Corporate Compliance shall issue an audit report to the vendor and shall get a compliance report, through the commercial department.
  • On satisfactory compliance, Corporate Compliance shall intimate plant Quality Head regarding the outcome of the audit. At Plant, QC shall continue the evaluation of consignment(s) till three approved consignments are received.
  • Discontinuation / Deregistration of approved/new vendor (Vendor Management):
  • Head Vendor Qualification Office, Quality, Head Commercial or Designee, may raise the “Vendor Deregistration Proposal” as per Annexure.
  • Criteria (but not limited to) for Deregistration of Vendor:
    • Critical
    • Annual Risk Assessment Data
    • Critical Non-conformance observed during Surveillance audits. (Critical Non-conformance: which directly/indirectly affects the Quality, Safety, Purity product and which are not complying cGMP Practices).
    • If the Vendor is suspended by the respective Regulatory Authority.
    • In case the item code is made “Obsolete” by the company.
    • Material is not procured from the Vendor for the minimum “Three Years”.
    • Vendor violets the Commercial Agreement/on termination of Commercial Agreement.
    • The vendor stops the manufacturing of the product/change in the Name of the Vendor/change in the Manufacturing Site.
    • Denial for audit by Vendor without justified reason.
  • Vendor shall be deregistered for specific to material/materials, specific site or block within one site depending upon the reason for deregistration.
  • The de-registration status of the vendor shall be communicated to Site Quality by Vendor Qualification Office.
  • Continuous evaluation of supply for quality (Q score):
  • The performance of all vendors for quality shall be evaluated by calculation of their Q Score.
  • The Q Score calculation shall be done electronically or manually with the following logic:
  • For every approved batch/lot, the vendor shall get 100points.
  • Every rejected batch/lot (on quality parameters), the vendor shall get 1 point.
  • For every partly accepted / partly rejected batch/lot, the vendor shall get 50 points.
  • In case of any on-line rejection where reason for rejection is confirmed as a problem with material supplied by vendor e.g. presence of foreign matter,non-homogeneity of material, presence of suspended matters in case of liquid material, etc. and not due to reasons attributable to storage conditions at different Sites, the vendor shall get 10 points or 60 points depending upon total rejection of part rejection respectively.
  • The overall Q Score is calculated by the formula:

Total earned score/number of the batches (or lots)

  • A vendor with a ‘Q Score rating’ of more than 90 % shall be continued as an approved vendor.
  • For vendors with Q Score less than 90%, QA shall conduct an evaluation by considering past supply history, the number of batches supplied, the reason for rejections, interaction with the vendor, etc.
  • Based on the outcome of the evaluation, Site Quality shall justify whether to continue with the procurement of material from the vendor or not.
  • Annual risk assessment (Vendor Management) :
  • Risk Assessment shall be performed for all the Vendors of API, KRM, KE, Primary Packaging Materials and Printed Packaging Materials once in a year by the concerned Site Quality.
  • The outcome of risk assessment shall be shared with the Vendor Qualification Office latest by end of December for the current calendar year.
  • Vendor Qualification Office shall prepare an Annual Vendor Audit Planner by consolidating data of Annual Risk Assessment received from all Sites.
  • Copy of Approved Audit Planner shall be shared with each Manufacturing Site and execution shall be from April to march (Financial Year).
  • Risk-Based Approach for planning Vendor Audits shall be based on two primary principles which are:
    • The evaluation of risk to cGMP status of Vendor and quality of material ultimately linking back to the protection of the patient.
    • The level of effort, formality, and documentation of the risk assessment process should commensurate with the level of risk and should be based on scientific knowledge.
  • Risk Assessment Methodology under vendor management:
  • The site shall create and maintain a list of all existing and potential Vendors of API, KRM, KE, Primary Packaging Materials and Printed Packaging Materials for the assessment period.
  • Identify the source of information of the Vendors and analyze the information to determine the risk of an individual Vendor.
  • Classify the potential risks arising from the assessment of each category/parameter into four levels namely High, Medium, Low, and Negligible.
  • Depending on the risk level of a parameter used for evaluation, a risk factor shall be assigned.
  • By using the potential risk for each category and risk factors, a Risk Priority Number (RPN) shall be calculated (quantitatively).
  • Risk Factors can be grouped into three categories as shown in the following table (Table E):

Table E: Types of Risk Assessment Categories

CategoryTypical parameters for assessment
SeverityThe criticality of material and impact on end-product quality
ProbabilitySupply history of Vendor and status of Quality Systems of the Vendor
DetectionPossibility of detecting quality failures for a material and the stage at which detection is possible (e.g. incoming inspection, final testing, etc.)
  • Severity:
  • This category describes the criticality of material for the quality of end product. Assessment for this category shall be done as per Table F.

Table F: Potential impact level of Category “Severity”

Assessment CriteriaImpact Assessment of risk levelRisk Factor
Material under consideration is API or KRM used for API manufacturing or Sterile ExcipientHigh10
Material under consideration is Primary or Printed PMMedium8
Material under consideration is non-sterile KELow4
Material under consideration is other than KRM/other than KE/other than primary or printed PMNegligible1
  • Probability of Occurrence:
  • This category considers the past supply history (from a quality perspective), product SISPQ (Safety, Integrity, Strength, Purity, and Quality) requirement, compliance status and state of quality systems of a Vendor.
  • The risk criteria “compliance” classifies the product SISPQ requirement compliance and regulatory compliance status of the Vendor using all available information from the company’s quality management systems.
  • Data for parameter ‘Compliance’ can be taken from different sources, for example, the previous audits, assessment of information are provided by the Vendor in Vendor questionnaire, etc.
  • If the compliance status is unknown, the highest risk level shall be used.
  • The vendor will be calculated by considering the Q Score of Vendor for the last three years.
  • In case of a new Vendor or existing Vendor for new material where no previous Q Score is available, for impact assessment of this parameter, it will be considered as high risk.
  • Assessment for parameters “supply history of Vendor” and “compliance” shall be done as per tables G, H and I respectively.

Table G: Potential impact level of Category “Supply History of Vendor”

Table G
  • In the case of an existing Vendor with the irregular supply of material, the assessment shall be done as per the following Table H.

Table H: Assessment criteria for irregular supply by existing Vendors

Table H
  • In case there is no supply history for a particular material for the previous three years, if the Vendor however has been supplying other materials regularly from the same site, the assessment may be done based on the supply history of the other materials being regularly supplied by Vendor from the same manufacturing site.

Table I: Potential impact level of Category “Probability of occurrence” and parameter “Compliance”

Assessment CriteriaImpact Assessment of risk levelRisk Factor
Compliance status by company audit or an inspection by the competent regulatory authority (USFDA, EDQM, Japanese or Any European health authority, WHO, TGA, Indian FDA, ANVISA, ISO, IPEC, etc.) available but older than 3 years or more for API and older than 5 years or more for KRM/KE/ Primary and Printed PM.High10
Compliance status by company audit or inspection by the competent regulatory authority (USFDA, EDQM, Japanese or Any European health authority, WHO, TGA, Indian FDA, ANVISA, ISO, IPEC, etc.) available but more than 2 years old for API and 4 years or more for KRM/KE/ Primary and Printed PM.Medium8
Status of Compliance by company audit or inspection by competent regulatory authority available, more than 1 year old, but less than or equal to 2 years for API and more than 3 years old, but less than or equal to 4 years for KRM/KE/ Primary and Printed PM.Low4
The vendor is audited by the company in the last one year for API and the last 3 years for KRM/KE/ Primary and Printed PM.Negligible1
  • The total risk for category Probability shall be arrived at by averaging risk factor of each parameter assessed under this category.

Total Risk (Probability) = {Risk factor (Supply History of Vendor)) + Risk factor (Compliance)} / 2.

  • Detection: This category considers the Possibility of detecting quality failures for a material and the stage at which detection is possible and the assessment shall be carried out as per Table J.

Table J: Risk Assessment for detecting possible quality failure for material at various stages

Assessment CriteriaImpact assessment of risk levelRisk Factor
Can be detected at in-process / intermediate stage / at finished product stage onlyHigh10
Can be detected during testing only but reduced testing performedMedium8
It can be detected at the receipt stage. No reduced testing performed, however, reduced sampling is done and vice versa.Low4
It can be detected at the receipt stage. No reduced testing / reduced sampling performedNegligible1
  • Evaluating the Total Risk Arising from a Vendor:
  • Evaluate the risks identified for all three categories (Severity, Probability, and Detection) for each individual Vendor.
  • Calculate the vendor’s overall risk Priority Number (RPN) by multiplying the total risk of each category.
  • Perform the risk assessment for each material and Vendor.
  • In case of different RPN numbers obtained for different material/ material type by the same Vendor, the worst-case shall be considered for deciding the requirement of onsite audit of Vendor.
  • Perform the risk assessment for materials manufactured and supplied by any of the site(s).
  • In the case of products that are manufactured for a customer, initially, the Vendors shall be approved based on the customer’s recommendation.
  • Perform the annual risk assessment of such Vendors as per this SOP.
  • Obtained the RPN values shall use for sorting Vendors according to their overall risk factor once in a year(preferably by the end of December).
  • Risk Control Evaluation and Audit Plan:
  • Risk control evaluation shall involve focusing the scope of risk management by selectively reducing risk control for low-risk suppliers and increasing risk control for high-risk suppliers as per Table K.

Table K: Risk Control Evaluation and Audit Plan.

Risk Priority Number (RPN)Actions
Less than or equal to 64 (Low Risk)No further actions required until the next risk assessment.
65-256 (Medium Risk)Paper-based audit
> 256 (High Risk)All such Vendors shall be included in the annual audit plan for the onsite audit.
  • The risk assessment shall be reviewed annually. However, in certain cases, the risk of Vendor may be re-assessed earlier also on the acquisition of new assessment data or multiple rejections of a material.

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