Purpose

Pharmaceuticals and medical device manufacturers must have a procedure for qualification and approval of new suppliers and the maintenance of approved and inactive suppliers. The procedure should be applicable to all medical devices (including testing and calibration) and drug products Contractors and contract services related to the services provided for medical devices and drug products. Services that may affect the quality or integrity of medical devices and drug products i.e. warehouse cleaning, temperature monitoring, etc.

Selection of the Supplier

Under the Supplier qualification procedure, Potential suppliers shall be identified by the quality department based on the needs of the company regarding the necessary product attributes or service requirements. They can be identified in a number of ways:

  • Request for Tender and evaluation process against specified requirements and specifications 
  • Existing suppliers with proven ability to meet the criteria. 
  • Recommendations from other affiliated groups or other suppliers whose products or services are acceptable to the service provided

Each potential supplier shall be sent a supplier evaluation checklist and requested to complete the document, returning to the quality department for approval.

If the supplier does not return the evaluation checklist a follow-up shall be initiated, by phone, fax, or e-mail. Alternate Suppliers (where available) may be contacted if no response is received. 

The returned checklist shall be reviewed by quality to assess the suitability and /or criticality of the supplier. The suitability and criticality shall be related to the products and services provided.

If the supplier does not meet the scope of this procedure mentioned above, this supplier does not require approval

Suppliers used prior to the implementation of the first issue of this procedure shall be grandfathered and will not be required to go through the initial supplier approval process.

Approval of the Supplier

The approval for a supplier shall be made by quality who will also maintain the supplier lists. The process of evaluating, selecting and controlling can include (where applicable):

  • Review of third-party evaluating reports

Review of historical data, such as records of past performance kept on accounting file. Certification by a third-party of the supplier’s quality management system. 

  • Auditing of the supplier’s quality management system by the organization.
  • Independently testing and trailing of successive lots of samples of raw materials to be procured

The results of material testing and the vendor questionnaire (evaluation checklist) are to be assessed and a decision made as to whether the vendor has the capability to produce the material in question and whether to proceed with the assessment process.  If the results are unacceptable then the selection process starts again.

For the supply of critical raw materials, the GMP Quality Assurance Procedure team will decide if a supplier site audit would be required. The frequency of supplier audits depends on the needs in the individual case and is to be determined by the auditor at the completion of the audit process and documented on the audit report. Audits shall be planned scheduled and conducted in line with company’s supplier / contractor audit program.

 After approval the appropriate lists shall be updated to include new suppliers and a file shall be created by the quality and supply chain for each supplier. If quality team does not approve the supplier, the supplier will be recorded on the unapproved supplier list and the unapproved checklist shall be filed.

If an approved supplier is no longer used, the supplier shall be removed from the approved suppliers List and added to the Inactive supplier’s List.  

Ongoing Assessment of Approved Supplier

Routine performance review should be conducted regularly by the quality assurance department. All critical suppliers shall be reviewed annually. A new supplier evaluation checklist shall be sent as a part of the routine review. 

All non-critical suppliers do not require an annual review and shall be reviewed as needed.

If the supplier does not return the supplier evaluation checklist, a follow up shall be initiated. A review of the suppliers shall be reported by the quality or commercial operations during monthly and annual review meetings. Any issues raised shall be followed up and clarified. If conditions of the supplier have changed, Regulatory shall be notified and shall make the necessary decision whether to approve the supplier, under the supplier Pharmaceutical validation procedures.