GroundRules
21 CFR 111.320: What requirements apply to laboratory methods for testing and examination?
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION
- 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
(a) You must verify that the laboratory examination and testing methodologies are appropriate for their intended use.
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON