Supplier Qualification

Supplier qualification is a requirement of the regulations, as set out by 21 CFR Part 111.75, which states that you must first qualify your supplier by establishing the reliability of the supplier’s certificate of analysis (COA) through confirmation of the results of the supplier’s tests or examinations.

Setting up a proper supplier qualification program is an essential step in maintaining dietary ingredient quality and integrity. An established vendor/supplier qualification program can help to identify reliable suppliers and justify reduced testing of incoming components.

This is can normally be done in three steps

  1. Confirmation of test results against COA
  2. Completion of vendor questionnaire and Audit of supplier
  3. Re-qualification of vendors as scheduled intervals

Our Services supplier qualification include:

  • Review of supplier technical documentation and specifications to ensure compliance with requirements of 21 CFR part 111
  • Perform preliminary COA verification testing
  • Risk assessment of supplier
  • Establish supplier qualification program
  • Supplier qualification questionnaire
  • Audit and Gap analysis of supplier facility
  • Develop identity testing procedures and establish microbiological and heavy metal testing specifications

At dicentra we have a team of experts qualified to assess your Suppliers and ensure they meet cGMP requirements, offering you peace of mind so that you can focus on your day to day business activities.