Recommendations for an Effective Vendor Qualification Program - Part 2 of 2

Written by Teresa Jaworski – Subject Matter Expert, QPharma


In last week’s post, I shared with you some preliminary guidelines for qualifying a vendor. Here is Part 2 of that post:

Pre-Audit Questionnaire

If it is determined that a new vendor is needed, you should select a minimum of three (3) vendors, if possible, which can supply the product or services needed ( raw materials, components, manufacturing equipment, testing equipment, consulting services, etc.). The approved procedure should provide guidance for selecting these vendors. Once the potential vendors are selected, a pre-audit questionnaire should be provided to and completed by each of the potential vendors. The results from the completed questionnaire should be used to determine if the vendor will continue in the qualification process.


Onsite Vendor Audit


If it is determined that the potential vendor meets the criteria for continuing the qualification process per review of the completed questionnaire, schedule an initial, onsite audit as defined in the approved procedures.


When conducting the audit, the appropriate audit checklist should be used according to whether the vendor is defined as a critical or non-critical vendor. In addition, the onsite audit should include verification that the established requirements and specifications can be met by the vendor. Then based on the overall results, the potential vendor can be either accepted or rejected. If accepted, the vendor is considered qualified. If rejected, the company can either work with the vendor to resolve discrepancies and qualify the vendor or select another potential vendor. All auditing activities and results should be documented and maintained.


Quality Agreement


If it is determined that the vendor is qualified, a written Quality Agreement should be developed and approved between the company and the vendor. According to Hasselbalch, “a GMP guidance detailing expectations for quality agreements is in the works as well, and the regulations may be further upgraded to support the guidance in this area. The guidance will explain the expectation that the agreement be in writing and specify clearly what each party commits to do.”


Development and approval of the Quality Agreement should include members from all relevant areas within the company’s organization, including but not limited to quality, procurement, manufacturing, product development, process development, regulatory, and legal. This agreement should define required quality standards; products or services provided; quality requirements and specifications including but not limited to training, qualifications, and monitoring expectations; key contacts; quality roles and responsibilities; locations; and necessary communications regarding quality-related activities.