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

21 C.F.R. § 111.315

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.

Notes, amendments, and revision history

Authority: 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264.

Source: 72 FR 34942, June 25, 2007, unless otherwise noted.