SOP on Vendor Qualification/Approval in Pharmaceutical Industry
To lay down a procedure for vendor approval.
This procedure is applicable for vendors supplying raw materials and packaging materials.
Quality assurance, Purchase, Quality Control and Warehouse
4.1 Procedure for raw material vendor approval
4.1.1 Purchase department shall identify vendor and shall communicate with QA department.
4.1.2 Communicate with vendor for 3 initial samples of material of different batches along with COA, specification, method of analysis along with CEP/DMF. Request for regulatory agency GMP certificate e.g. MHRA, USFDA, TGA etc. and manufacturing license and approval from the local authority.
4.1.3 Enter the details of received samples in log and verify availability of requested documents.
4.1.4 Verify the manufacturing site address mentioned in COA and labels matching with the address mentioned in the DMF/CEP or equivalent document.
4.1.5 Check the test parameter and results in COA against the specification.
4.1.6 Send the sample to QC for analysis.
4.1.7 Reject the vendor if any of the batch fails to meet the specification.
4.1.8 If all 3 batches pass in QC, arrange for site inspection for API and critical excipients.
4.1.9 Send the self-assessment questionnaire to vendor for non-critical excipient and approve if filled self-assessment questionnaire found satisfactory upon review. Request further iformation if required.
4.1.10 Conduct the site audit as per pre-defined checklist.
4.1.11 Prepare the audit report and classify the findings as critical, major, minor and recommendation.
4.1.12 Send the audit report along with findings to vendor for Corrective And Preventive Actions (CAPA).
4.1.13 Based on findings approve, conditionally approve or reject the vendor.
4.1.14 Ask the vendor to send the CAPA within 30 days of the receipt of audit report.
4.1.15 Verify the CAPA received from vendor and take final decision on approval or rejection.
4.1.16 Update the vendor as approved in vendor database and mention the next audit/assessment due date (due date maximum 3 years from last audit).
4.1.17 After vendor approval, monitor first 3 API batches by QC analysis, in case any batch fail due to OOS (Out Of Specifications), reject the vendor.
4.1.18 If API is used from any vendor for exhibit batch (stability batch) or pilot scale batch, approve the vendor based on self-assessment questionnaire, however audit the site before release of the first commercial batch.
4.2 Primary and secondary packaging material vendor approval:
4.2.1 Purchase department shall identify suitable vendor.
4.2.2 Conduct the site audit of the vendor and if not possible send the self-assessment Questionnaire. Justify the reason for not performing site audit.
4.2.3 Conduct the site audit as per pre-defined checklist.
4.2.4 Prepare the audit report and classify the findings as critical, major, minor and recommendation.
4.2.5 Send the audit report along with findings to vendor for corrective and preventive actions.
4.2.6 Based on findings approve, conditionally approve or reject the vendor.
4.2.7 Ask the vendor to send the CAPA within 30 days of the receipt of audit report.
4.2.8 Verify the CAPA received from vendor and take final decision on approval or rejection.
4.2.9 Update the vendor as approved in vendor database and mention the next audit/assessment due date (due date maximum 3 years from last audit).
4.3 Generate the code for raw material and packaging material in ERP/SAP after vendor approval.
4.4 Maintain the technical agreement with the vendor of API and critical excipient.
4.5 Conduct the re-audit within 3 years from the date of last audit as per procedure mentioned in previous section. QC samples shall be requested for initial vendor approval only. Vendor can be audited prior to scheduled due date in case of regulatory failure, repeated OOS, complaint, deviation etc.
4.6 Delay in re-audit shall be rooted through deviation. Procurement and use of material from the site shall be based on risk assessment. Vendor may be blocked temporarily until site audit or assessment is performed.
4.7 Finding classification:
Critical: A critical finding is one in which there is a clear GMP failure and which could affect the quality of the product and which could, or would, be harmful to the patient. Data falsification and fraud shall be classified as critical. A combination of major deficiencies, which indicates a serious system failure, may also be classified as a critical deficiency.
Major: A major finding is one which may have risk for the patient health (but not serious) or a direct non-compliance to GMP but measures are in place to mitigate the risk.
Minor: Any observation which can not be classified as critical or major and not having direct impact on product quality, efficacy and patient safety.
Recommendation: Any existing practice, process that could cause GMP issue in future if left unnoticed.
Approved: Vendor found satisfactory after site audit or by questionnaire-based assessment and procurement of material can be started/continued.
Conditionally approved: New business or continuity of existing business shall depend on satisfactory compliance of audit findings. Vendor may be approved or rejected based on compliance.
Rejected: Vendor shall not be used for new business or existing business shall be discontinued.
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