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This article discuss about a risk-based approach to qualifying, managing and auditing third party providers.

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.

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.

Supplier qualification is just one component of a larger supplier quality management system. 

You can download, The Complete Guide to FDA-Regulated Supplier Qualification & Quality Management, to learn more about protecting yourself from supplier-related compliance issues.



1. Outsourcing under greater scrutiny

2. Regulatory requirements for supplier management

3. Qualifying suppliers, vendors & other contractors

4. Writing an effective quality agreement

5. Managing supplier quality: a risk-based approach

6. Maintaining quality and improving supplier performance through auditing

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