CFR section
21 CFR 820.50(a): Purchasing controls
PART 820-QUALITY SYSTEM REGULATION · Subpart E-Purchasing Controls
Key facts
| Citation | 21 CFR 820.50(a) |
|---|---|
| Section | Purchasing controls |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart E-Purchasing Controls |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Biologics, Devices, Drugs, Food/Cosmetics, General, Other_Regulations |
| Regulation text (excerpt) | (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… |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.