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SOP for Supplier Qualification

This SOP describes how a supplier of a given raw materials or primary packaging materials shall be assessed and approved.

Applies to the approval of suppliers of raw and primary packaging materials that are used in manufacturing process inside XYZ Ltd.

  • Supply Chain Manager/designee: Qualifying the supplier according to the price and delivery rate & time.
  • R&D Specialist: Performing all checks trials and test runs to measure, and evaluate the performance characteristics of the materials.
  • Quality Control Analyst: Performing all physical, chemical, and biological tests (if appropriate) on supplier samples.

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  • Quality Assurance Responsible Personnel:
  1. Submitting a supplier Evaluation Questionnaire to the supplier for reply.
  2. Organizing an auditing team from other departments (according to need) to perform site inspection of the supplier.
  • Quality Assurance Manager/designee: Final decision of approval or disapproval of the supplier depending on the support results performed by purchasing, QC, Production & QA in the final QA report.


The criteria of supplier selection are:
  • Price comparison.
  • Fast delivery time.
  • Long-term delivery contracts.
  • Quality.
  • Good correspond with the monograph.
  • Manufacturer is specified in the registration dossier.
  • Experiences.
Qualification of the suppliers:
  • Addition of a new supplier shall be done through change control system according to SOP.
  • The required company specifications shall be sent to the supplier and necessary 3 samples of material “3 different batches” shall be requested for testing at XYZ Ltd., Quality Control department.
  • A trial batch of the finished product shall be prepared and evaluated by R&D department and full testing of the three samples by Quality Control department shall be done to measure the material performance.
  • Results of all the three samples shall be compared with the results on manufacturer’s certificate of analysis.
  • If the test results generated by XYZ Ltd., Quality Control and R&D departments are found to be satisfactory, a supplier questionnaire shall be sent to the supplier to ensure that adequate process controls are in place and cGMP requirements are in compliance as per Annexure.
  • Complete testing of the first consecutive 10 supplier’s batches shall be conducted.
  • The first production batch(es) of the finished product manufactured using the new raw material shall be considered as a validation batch(es).
  • The supplier shall be categorizes as a provisional supplier till the results of first 10 supplier batches complete.

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  • If the questionnaire shows acceptable reply and the first 10 batches of the supplier show compatible results with the results in supplier’s certificate, then the supplier shall be as approved supplier.
  • The supplier’s facility shall be audited (if applicable) or XYZ Ltd., may ask the supplier to support them with the certificate(s) of inspection whether from the regulatory authority or independent quality certification organization.
  • If the supplier’s site auditing shows that supplier meets cGMP requirements as established by XYZ Ltd., Quality Assurance auditor, or depending on the certificate(s) of inspection, the supplier shall be as a certified supplier.
Reduced Testing:
  • Quality Assurance and Quality Control Managers shall decide for reduced testing of incoming material received from the supplier according to the supplier status (Approved / certified).
  • Once starting reduced testing, Quality control Manager shall determine the selection of appropriate tests required to accept material from supplier under the reduced testing program - depending on the sampling skipping plan -. Selection shall be based on test criteria which can detect potential quality changes of material during handling and transportation from the supplier to XYZ Ltd., warehouse.
  • If any quality issues arise “Deviation, Out Of Specification, Change request, etc.”, impact assessment on the approved status shall be evaluated. Increase testing or full testing shall be considered till issues resolved.
  • If one or more lot / batch are rejected by QC for an approved supplier, an investigation needs to be conducted by quality assurance to determine cause and to establish the required CAPA.
  • When changes are notified by the supplier, impact assessment on the approved status shall be evaluated and any necessary action(s) taken. This may include a period of increase or full testing after the changes have been implemented.
  • Any amendment of the testing program, as a result of this factor, shall be considered.
  • Once changes have been satisfactory implemented and / or quality issues resolved, the material could be returned to its reduced testing program.
  • A periodic re-qualification of suppliers shall be done based on review of correspondence with the supplier about facilities, process, or control method changes, and review of inspectional history of supplier by XYZ Ltd.

Disqualification of suppliers:
  • Any supplier can be disqualified under following circumstances:
  • Inconsistent quality which may affect drug product stability.
  • Irregular supply including extreme delays in supplying the material as per time commitment provided by suppliers.
  • Changing the manufacturing process, cross contamination, improper labeling information, or shelf life of API without proper notification to XYZ Ltd.
  • QA shall issue a written communication to Supply Chain Manager for disqualifying any supplier with proper justification.
  • Disqualified supplier should be reassessment after implementation the needed CAPA for disqualification reasons.

Supplier Questionnaire

CAPA: Corrective Actions, Preventive Actions.
cGMP: Current Good Manufacturing Practice.
R&D: Research and development.


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