PART 610.12 — CBER GENERAL BIOLOGICAL PRODUCTS STANDARDS PROPOSED
Enclosed is the summary of the proposed requirements for the revised CBER 610.12 Sterility Test. For additional information, please see below for a summary or visit the enclosed web site for the full release http://www.gpo.gov/fdsys/pkg/FR-2011-06-21/pdf/2011-15346.pdf
The authority citation for 21 CFR part 610 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 264.
Section 610.12 is revised to read as follows:
§ 610.12 Sterility.
(a) The test.
Except as provided in paragraph (h) of this section, manufacturers of biological products must perform sterility testing of each lot of each biological product’s final container material or other material, as appropriate and as approved in the biologics license application or supplement for that product.
(b) Test requirements.
(1) The sterility test must be appropriate to the material being tested such that the material does not interfere with or otherwise hinder the test.
(2) The sterility test must be validated to demonstrate that the test is capable of reliably and consistently detecting the presence of viable contaminating microorganisms.
(3) The sterility test and test components must be verified to demonstrate that the test method can consistently detect the presence of viable contaminating microorganisms.