eCFR Reference Browser

---

title: "21 CFR §111.320"

source: "https://www.ecfr.gov/current/title-21/section-111.320"

title_number: "21"

volume_number: "2"

chapter_number: "Unknown"

subchapter_code: "B"

subchapter_subject: "FOOD FOR HUMAN CONSUMPTION"

part_code: "111"

part_subject: "CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS"

subpart_code: "J"

subpart_subject: "Production and Process Control System: Requirements for Laboratory Operations"

section_number: "111.320"

section_subject: "What requirements apply to laboratory methods for testing and examination?"

cfr_reference: "21 CFR 111.320"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 100 to 169"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

§111.320 - What requirements apply to laboratory methods for testing and examination?