Supplier Assessment Questionnaire

Pharmaceutical manufacturers and industry suppliers recognize the inefficiency and waste of resources when each individual pharmaceutical company creates its own supplier assessment questionnaire. Suppliers routinely exhaust valuable resources continuously completing slightly different forms of substantially similar questionnaires. In order to create the Rx-360 Supplier Assessment Questionnaire (SAQ), the Working Group analyzed numerous sample questionnaires submitted by Rx-360 members.

The Rx-360 SAQ covers standard information that would be included in most supplier assessment questionnaires. The 6-part questionnaire is more detailed than most but will decrease the number of times that questionnaires will need to be filled out by the supplier, while significantly decreasing the turn-around time back to manufacturers.

Watch the SAQ Tutorial

download saq support documents

information to share when requesting completion of the saq from a supplier

manufacturer user guide

supplier user guide

module descriptions

SAQ  Instructions

Manufacturer Instructions

1.The manufacturer directs the supplier to the SAQ online at Rx-360.org/SAQ.

2.Indicate the modules you request and/or require to be completed.

  • Refer to SAQ Module Descriptions and specify which modules you need completed by the supplier:
    • ·Module 1 – Company Information
    • ·Module 2 – Site-Specific Information
    • ·Module 3 – Product Information
    • ·Module 4 – Service Supplier
    • ·Module 5 – Pre-Audit Questionnaire
    • ·Module 6 – Single Use Bioprocessing Products

3.Receive completed SAQs.

  • Expect the supplier to send you their completed SAQ in a PDF (for human review) and a JSON (for computer use).

4.Incorporate the completed SAQ into your supplier qualification process.

  • Note anything from the completed SAQ that require further review and/or documentation and proceed according to your organization’s process (e.g., requesting additional documents).

5.Use completed SAQ files to compare responses across time and/or across suppliers, according to the needs of your organization.

Supplier Instructions

Access the SAQ online at Rx-360.org/SAQ.

  • Complete the module(s) relevant to your company, sites, products, services, or as requested/required by the requestor (e.g., manufacturer). You may complete and maintain your SAQ response proactively, instead of or in addition to replying to a request.

2. Complete the questionnaire.

  • Fill out the forms with accurate and current information. Modules are structured to cover Company, Site, Product, Services, Pre-Audit, and Single-Use Bioprocessing topics.
  • You may need to fill out a given module multiple times in case of multiple sites or products.

3. Sign your submission.

  • You will electronically sign your completed SAQ and attest that the information is accurate.

4. Review and send.

  • You will receive two files via email for each module that you fill out.
    • The PDF document will contain all of the information in a human readable form.
    • The JSON file contains all of the same information in a computer readable format. This can be used to import answers to the form to make updates, share with colleagues or maintain multiple answer sets (e.g. one for each product), and enable migration to newer versions of the SAQ.
  • Once you review the PDF and are happy with it, please share both the PDF and JSON files with the requestor. Information is not shared directly with requestors and is never stored on Rx-360 servers.

5. Keep your information current.

  • Review and update your SAQ response regularly to ensure your customers have the most accurate information.

Disclaimer

This document is for informational purposes only. Users are responsible for ensuring that the document meets their individual needs and adjusting it accordingly. RX-360 MAKES NO WARRANTIES, EXPRESS, IMPLIED, OR STATUTORY, AS TO THE INFORMATION IN THIS DOCUMENT. Complying with all applicable laws is the responsibility of the user.