820.50 Purchasing controls.

Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.

(a) Evaluation of suppliers, contractors, and consultants. Each manufacturer shall establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Each manufacturer shall:

(1) Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented.

(2) Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results.

(3) Establish and maintain records of acceptable suppliers, contractors, and consultants.

Interpretation:

It is difficult to imagine an organization not depending somewhere in their supply chain on another organization to provide for supplies or services.  When these supplies and services cross into the critical realm (can affect safety and efficacy) then a supplier should be evaluated.  There are instances where it is difficult or next to impossible to evaluate a supply or service.  In this situation the FDA asks that you conduct 100% inspection on incoming goods and services.

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Reference: www.FDA.gov

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