21 CFR 111.320: What requirements apply to laboratory methods for testing and examination?
Requires dietary supplement manufacturers to verify that laboratory testing and examination methods are appropriate for their intended use, and to use a scientifically valid method for each specification that must be tested.
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
Recent 483s citing 111.320
- Aspire Pharmaceuticals Inc. · Somerset, New JerseyYou did not ensure that the tests or examinations that you used to determine… Feb 3, 2022
- Tower Laboratories Ltd · Montague, MichiganYou did not verify that the laboratory examination and testing methodologies are… May 2, 2019
- Wyeth Pharmaceutical,Div Wyeth Holding Corp · Pearl River, New YorkLaboratory exam and test methodologies do not appear to be appropriate for their… Oct 8, 2008
The regulation text
§ 111.320 What requirements apply to laboratory methods for testing and examination?.
(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.
Questions
What does 21 CFR 111.320 require?
Requires dietary supplement manufacturers to verify that laboratory testing and examination methods are appropriate for their intended use, and to use a scientifically valid method for each specification that must be tested.
Which sections are cited alongside 111.320?
In the same 483s, investigators most often also cite 111.75 (What must you do to determine whether specifications are met?), 111.105 (What must quality control personnel do?), 111.113 (What quality control operations are required for a material review and disposition decision?), 111.123 (What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations?).