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

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

Use of criteria for establishing appropriate specifications;

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

Components, packaging, and labels;

In-process materials;

Finished batches of dietary supplements;

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

Packaged and labeled dietary supplements.

Use of criteria for selecting appropriate examination and testing methods;

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

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

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§ 111.310 - What are the requirements for the laboratory facilities that you use?
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§ 111.320 - What requirements apply to laboratory methods for testing and examination?