§111.110. What quality control operations are required for laboratory operations associated with the production and process control system?

21 C.F.R. § 111.110

Quality control operations for laboratory operations associated with the production and process control system must include:

(a)

Reviewing and approving all laboratory control processes associated with the production and process control system;

(b)

Ensuring that all tests and examinations required under § 111.75 are conducted; and

(c)

Reviewing and approving the results of all tests and examinations required under § 111.75.

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.