SOP on Supplier Qualification / Vendor Qualification / Vendor Management / Vendor Approval Procedure / Approved vendor list template

 

SOP on Supplier Qualification / Vendor Qualification / Vendor Management / Vendor Approval Procedure / Approved vendor list template

All pharmaceutical industries are following the vendor/service provider approval or rejection procedure. Vendor qualification is required to evaluate the product quality, vendor capability, consistency, reproducibility etc.


SOP on Supplier or Vendor Qualification / Vendor Management / Vendor Approval / Approved vendor list template


1.0 PURPOSE:

This Standard Operating Procedure (SOP) describes the procedure for approval or disapproval of suppliers or vendors.

2.0 SCOPE:

2.1 This procedure applicable for all who are involved in the selection, evaluation, and approval / rejection of supplier/vendor.

2.2 All raw material (RM), packaging materials (PM), garments (Gown), gloves, and other material that is used in the pharmaceutical industry.

3.0 RESPONSIBILITY:

3.1 Purchase:

3.1.1 Identification of new vendors and collection of all the information/data from the vendor/ supplier.

3.1.2 Support to the concerned department for collection of data from the vendors/suppliers.

3.1.3 Act as intermediate between vendors/suppliers and manufacturer.

3.1.4 Inform about approval/rejection to the vendors/suppliers.

3.2 F & D / Process development (PD) lab:

3.2.1 Enter the details of the samples into the logbook.

3.2.2 Based on the trial decide the suitability of the materials.

3.2.3 Justify the criticality of the materials.

3.3 Store/warehouse:

3.3.1 Follow the “Approved Vendor List”

3.4 Quality Control/ Analytical Development Laboratory (ADL):

3.4.1 Initial the entry of sample into the logbook.

3.4.2 Analytical testing of the sample for purity, OOS, rejection, compatibility of samples.

3.5 Quality Assurance:

3.5.1 Verification of the initial sample, Certificate of Analysis (COA), and other documents.

3.5.2 Verification and evaluation of data collected from the vendors, F&D/ PD lab, ADL

3.5.3 Verification and evaluation of monthly rejection trends for respective materials.

3.5.4 Prepare and update “Approved Vendor List”, Vendor Audit plan/schedule.

3.5.5 Conduct audit of vendors/suppliers as per schedule.

3.5.6 Follow up and the verification of vendor audit response.

3.5.7 Communicate with departments for the data discrepancies.

3.6 Head Quality Assurance:

3.6.1 Approval of vendors list.

3.6.2 To escalate to senior management in case of any delay against the planned schedule in advance with an action plan.

3.6.3 Approve list of auditors.

3.6.4 Approval of vendor audit response

3.6.5 Decision on continue / discontinue of existing vendors.

4.0 DEFINITION:

4.1 Vendor / Supplier:

Vendor is person or company selling something to the customer like items, services etc. Vendor can also manufacturer or supplier (distributor).

4.2 Vendor/Supplier Qualification:

Vendor/Supplier qualification is documented evidence that provides a high degree of assurance that vendor/supplier supplying materials consistently produce a result with predetermined rate.

5.0 PROCEDURE:

5.1 New vendors/supplier qualification procedure:

5.1.1 Manufacturing /F&D/ADL department send the details of the required material to purchase department.

5.1.2 Purchase the department should identify the vendors/suppliers.

5.1.3 Evaluate the vendor details, manufacturing capability, quality details, technical information by vendor questionnaire.

5.1.4 Following documents should require for the qualification of vendors but not limited:

5.1.4.1 Filled Vendor questionnaire

5.1.4.2 Sample of 3 consecutive batches with COA.

5.1.4.3 Brief manufacturing process

5.1.4.4 Manufacturing process chart

5.1.4.5 Specification / Method of Analysis (MOA)

5.1.4.6 TSE/BSE free declaration

5.1.4.7 Genetically Modified Organism (GMO) free declaration

5.1.4.8 Melamine/Gluten free declaration

5.1.4.9 Residual solvent declaration

5.1.4.10 Food grade certificate in case of packing material

5.1.4.11 Stability data

5.1.4.12 Elemental impurity profile

5.1.4.13 Latex free declaration

5.1.4.14 Organogram / Organization Chart

5.1.4.15 Accreditation (USFDA, WHO, ANVISA, EU, TGA, MHRA etc)

5.1.4.16 Declaration for no manufacturing of herbicides, pesticides, hormones, beta-lactam, steroids, cephalosporins, penicillins, cytotoxin.

5.1.4.17 Tamper evident seal declaration

5.1.4.18 Container closure system

5.1.4.19 Declaration for following GMP system

5.1.5 For Raw material, Purchase department communicates with the vendors or supplier for samples of 3 different batches with a certificate of analysis (COA), material specification, method of analysis (MOA), Certificate of suitability (CEP).

5.1.6 Quality Assurance (QA) receives the samples to develop the vendors.

5.1.7 Check and enter the details of the samples int0 the register like Name of material, Quantity of sample, Date of receiving, Address of manufacturer etc.

5.1.8 Vendor address on label and manufacturing site should be the same.

5.1.9 Quality Assurance (QA) check the availability of the other required documents by the vendors like TSE/BSE, Melamine, GMO-free certificates etc.

5.1.10 QA person should divide the sample into two equal parts in the store dept. and enter the details of the activity in store logbook.

5.1.11 One sample send to F & D / PD lab and another sample send to ADL / QC lab.

5.1.12 Provide the sample COA and specification / MOA to F & D / PD lab / ADL /QC for reference.

5.1.13 After completion of trial or analysis F & D /PD lab and ADL/ QC submit their evaluation report.

5.1.14 QA person should review the report and based on the review Head QA decide for provision approval of vendors/ supplier.

5.1.15 Inform the supplier/vendor if any additional recommendation required regarding sample analysis.

5.1.16 QA person inform to purchase department about approval or rejection of sample.

5.1.17 If any abnormality observed during trial or testing of the sample initiate the non-conformance/deviation or OOS.

5.2 Provisional/Temporary Approval of Vendor:

5.2.1 After satisfactory evaluation of the data, Head QA temporarily approved the vendors.

5.2.2 QA person should fill the details of the vendor in “Provisional Approved Vendor”.

5.2.3 Take the photocopies of “Provisional Approved Vendor” and stamp by “Photocopy for reference only”.

5.2.4 Send these photocopies to the Store, QC, and Purchase department.

5.2.5 QA should provisionally approve vendor for 9 months.

5.2.6 Within 9 months QA should plan for the vendor audit.

5.2.7 After successful audit QA should approve the vendor for the next 5 years.

5.3 Vendor / supplier audit:

5.3.1 QA person should communicate with the purchase department and plan for the audit.

5.3.2 QA person should prepare audit team member and QA person must be a part of an audit team.

5.3.3 Audit schedule details and audit agenda send to the vendor/supplier via email.

5.3.4 QA person should issue the audit checklist or checkpoints to the audit team.

5.3.5 Vendor/supplier site should be audited as per the checklist by the audit team.

5.3.6 Audit finding should be categorized as critical, major, minor.

5.3.7 After audit QA person should send the audit findings to the purchase department.

5.3.8 Purchase department sends the audit findings to the vendor/ supplier.

5.3.9 Vendor /supplier should respond to the audit findings in 30 working days.

5.3.10 After receiving the compliance report from the vendor. QA person should verify the compliance report.

5.3.11 Re-audit required to ensure compliance with the critical findings.

5.3.12 Head QA approved the vendor based on the evaluation of the compliance report.

5.3.13 QA should update the approved vendor list once in 6 months.

5.3.14 In case of API and primary packing material (PPM) audit is carried once in 3 years or major change in process or testing which may impact on product quality.

5.3.15 In case of excipients, secondary packing material, garments, gloves etc. evaluation carried out based on the vendor questionnaire. Audit should be carried out based on the requirement and the decision of Head QA.

5.4 Existing / Periodic vendor qualification or requalification procedure:

5.4.1 Vendor / Supplier should be approved for the 5 years after expiration or due date vendor/supplier requalification is required.

5.4.2 All documents should require for the requalification of the vendor/supplier as per point no. 5.1.4 but a material sample is not required for the requalification of vendor/supplier.

5.4.3 If any major changes have done related process, testing during previous 5 years then the details of that changes are required during the requalification of vendors/suppliers.

5.4.4 QA head should decide on the requirement of the audit based on the rejection criteria and the impact of major changes of vendor/supplier on manufacturing process or testing.

5.4.5 Vendor requalification frequency is 5 years ± 30 days.

5.5 Rejection trend:

5.5.1 Collect data from QC prepare monthly rejection consignment trend on monthly basis.

5.5.2 If the monthly rejection trend is beyond the specified limit, take further action as per below:

5.5.2.1 If 5% of consignment rejected then CAPA is required from the vendor/supplier.

5.5.2.2 If 10% of consignment rejected then issue caution letter and CAPA required.

5.5.2.3 If 15% or more of consignment rejected then issue the warning letter and block temporary, if CAPA is not satisfactory then reject vendor permanently. Remove the vendor form the vendor list.

5.5.3 Vendors/suppliers details should be included in the Annual Product Review (APR)

5.5.4 Vendor quality assessment and audit of vendors/ suppliers should be carried out if the rejection rate is more than 15%.

5.6 Vendor disqualification:

5.6.1 Vendors/suppliers disqualification based on the following criteria but not limited:

5.6.1.1 Failing to meet GMP requirements

5.6.1.2 Consistently 3 lots are failed to meet quality

5.6.1.3 15% or more consignments are failed to meet the quality

5.6.1.4 Critical failure in a testing (potency, microbial testing, etc)

5.6.1.5 Audit failure or compliance failure after warning letter issued

5.6.2 If any vendor disqualified or discontinued then QA person filled the “Vendor Disqualification / Discontinuation form”.

Take the photocopies of “Vendor Disqualification /Discontinuation form” and stamp by “Photocopy for reference only”.

5.2.4 Send these photocopies to the Store, QC, and Purchase department.

5.3 Preparation of approved vendor list and updation of vendor list:

5.3.1 Approved vendor list should be prepared by the QA person.

5.3.2 Vendor list number should be s per below:

RM/YYYY/ZZZ     &     PM/YYYY/ZZZ

RM – Raw Material

PM – Packing Material

YYYY – Year of vendor list preparation e.g. 2021

ZZZ – serial number of vendor list e.g. 001 after updation 002

5.3.3 Take photocopies of the approved vendor list stamped as “Controlled Copy” and issue to QC and store department.

5.3.4 Maintain the details of issuance in the vendor list issuance logbook. QC and store department person sign and date on the logbook after receiving the copy.

5.3.5 During issuance of the new vendor list old copy of the approved list and the copies of “Provisional Approved Vendor”, “Vendor Disqualification /Discontinuation form” should be collected by the QA person.

5.3.6 Approved vendor list history should be maintained into the “Approved vendor list change history

5.3.7 Received an old copy of vendor list is stamped as “Obsolete” by QA person.

5.3.8 Vendor list should be updated once in 6 months.

5.3.9 During updation of the vendor list consider the following points:

5.3.9.1 Addition of new vendors/suppliers or provisionally approved.

5.3.9.2 Name changes of vendor/supplier

5.3.9.3 Deletion of vendor/supplier (Disqualified or discontinued)

5.3.10 An obsolete copy of the approved vendor list should be store lifetime.

6.0 ABBREVIATIONS:

SOP – Standard Operating Procedure

F & D – Formulation and development

OOS – Out of Specification

COA – Certificate of Analysis

API - Active Pharmaceutical Ingredient

FDA - Food and Drug Administration

GMP - Good Manufacturing Practices

% - Percentage

EU - European Union

USFDA - United States Food and Drug Administration (USA)

TGA – Therapeutic Goods Administration (Australia)

ANVISA – Agencia Nacional de Vigilancia Sanitaria (Brazil)

MHRA - Medicines and Healthcare products Regulatory Agency (UK)

TSE – Transmissible Spongiform Encephalopathy

BSE – Bovine Spongiform Encephalopathy

CAPA – Corrective Preventive Action Plan

7.0 REFERENCES

7.1 ICH Q7, Good Manufacturing Practice guide for Active Pharmaceutical Ingredients

7.2 21 CFR 211.84 Testing and approval or rejection of components, drug product containers, closures. Parts211Subpart-211.60,211.165,211.167

7.3 Drug and Cosmetic Act 1940 and Rules1945, Schedule M, Good Manufacturing Practices and requirements of premises

7.4 ISO 15378: Primary packaging materials for medicinal products

7.5 ISO 15747: Plastic containers for intravenous injections

8.0 HISTORY

NA

9.0 ANNEXURE

9.1 Approved vendor list issuance logbook

9.2 Provisional vendor approval form

9.3 Approved vendor list (API & Excipients)

9.4 Approved vendor list (Packing Material)

9.5 Vendor disqualification /discontinuation form

9.6 Approved vendor list change history

9.7 Vendor qualification flow chart

 

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