eCFR Reference Browser

---

title: "21 CFR §111.315"

source: "https://www.ecfr.gov/current/title-21/section-111.315"

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: "111.315"

section_subject: "What are the requirements for laboratory control processes?"

cfr_reference: "21 CFR 111.315"

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"

---

You must establish and follow laboratory control processes that are reviewed and approved by quality control personnel, including the following:

(a)Use of criteria for establishing appropriate specifications;

(b)Use of sampling plans for obtaining representative samples, in accordance with subpart E of this part, of:

(1)Components, packaging, and labels;

(2)In-process materials;

(3)Finished batches of dietary supplements;

(4)Product that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier); and

(5)Packaged and labeled dietary supplements.

(c)Use of criteria for selecting appropriate examination and testing methods;

(d)Use of criteria for selecting standard reference materials used in performing tests and examinations; and

(e)Use of test methods and examinations in accordance with established criteria.

§111.315 - What are the requirements for laboratory control processes?