CFR section
21 CFR 111.320(b): What requirements apply to laboratory methods for testing and examination?
PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS · Subpart J-Production and Process Control System: Requirements for Laboratory Operations
Key facts
| Citation | 21 CFR 111.320(b) |
|---|---|
| Section | What requirements apply to laboratory methods for testing and examination? |
| Part | PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS |
| Subpart | Subpart J-Production and Process Control System: Requirements for Laboratory Operations |
| Subchapter | 21 CFR B Food |
| Product types cited | Drugs, Food/Cosmetics |
| Regulation text (excerpt) | (b) You must identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required to determine whether the specification is met. |
At a glance
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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.