A 5-Step Guide to Qualifying FDA-Regulated Suppliers

Supplier qualification processes aren't just recommended precautions to guard against compliance issues, they're a regulatory requirement for most FDA-regulated manufacturers.

"Qualifying" a supplier, in this case, should be thought of as a kind of quality system within a quality system.

Candidate suppliers and vendors should be thoroughly evaluated against your own quality requirements, compared with other options, physically evaluated, and reevaluated on a regular basis to ensure compliance both now and in the future.

Although most drug and device manufacturers have a supplier qualification process in place already, one company's approach can look much different than another's.

We’ve laid out a clear and concise five-step supplier qualification process that can be integrated and expanded upon to meet your organization's unique needs.

1. Define Requirements and Develop Questions for Potential Candidates

Before you can assess a supplier’s ability to address your needs, you need to define and document those requirements thoroughly. Although each situation is unique, consider the following areas when putting together your list:

  • Manufacturing/production capabilities
  • Quality standards and certifications
  • Regulatory and compliance requirements
  • Technological capabilities
  • Customer service standards
  • Delivery and cycle times
  • Product lifecycle management

In most cases, the change control system is the appropriate place to document this information. Avoid relegating this duty to just one person or a small team. Experts from each of these areas should be engaged in creating questions.

2. Compile Candidates and Assess Capabilities

Once you’ve fully defined and documented your requirements, begin engaging potential candidates to gauge their level of interest in partnering with you. Present your requirements to those open to a potential relationship.

In return, you should receive not only an explanation of how the supplier can satisfy your requirements but full documentation to support these claims.

If a particular product is involved, request a sample to evaluate it yourself. If your list of potential candidates is lengthy, narrow it down to no more than five companies. Evaluate each of your top candidates to ensure their documentation provides everything needed to perform a thorough assessment.

3. Evaluate Candidates and Identify a Top Pick

With a shortlist of top candidates, a more thorough evaluation of each of them can begin. Start by comparing each candidate’s relative ability to meet your requirements compared to the others.

A simple table like the one shown below can be used as a comparison tool. Devise a numeric rating system to apply to each requirement depending on a candidate’s capabilities. This allows for easier comparison between candidates.

Try to keep the comparison system as simple and practical as possible.


Requirement #1

Requirement #2

Requirement #3

Supplier A




Supplier B




Supplier C




Supplier D




4. Perform a Comprehensive Supplier/Vendor Audit

Once a top candidate is identified, a thorough audit should be planned and executed either on or off-site, depending on the nature of the product or service provided.

Both critical and noncritical supplier and vendor roles deserve thorough auditing, but critical roles, in particular, should be subjected to an on-site audit with predetermined items requiring verification.

Acceptance or rejection of a supplier candidate should ultimately be determined after reviewing the results of the audit.

Grab our free white paper for a step-by-step guide to planning and running a thorough supplier audit.

5. Re-qualify Suppliers On a Routine Basis

After qualifying a supplier, performance should be monitored regularly to identify and address any issues related to the products or services provided.

Create a schedule for performing periodic audits to address both pre-approved audit verification steps as well as potentially problematic areas observed during previous audits.

How frequently you conduct these audits should be determined based on how critical the supplier's products and/or services are to the final product, as well as their track record for regulatory compliance. Those with a history of issues should be monitored closely.

📄 Supplier qualification is just one component of a larger supplier quality management system. Grab our free white paper, The Complete Guide to FDA-Regulated Supplier Qualification & Quality Management, to learn more about protecting yourself from supplier-related compliance issues.

Supplier Qualification

The Complete Guide to FDA-Regulated Supplier Qualification & Quality Management

This guide offers manufacturers of actionable summaries and expert analyses of common CGMP compliance and QMS problems, along with key questions for assessing supplier compliance accordingly.

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Topics: Process, Quality Standards, FDA Auditing, GxP, FDA Compliance