General requirements for live virus vaccines.

CFR · 2024-01-01 · US · Title 9

When prescribed in an applicable Standard Requirement or in the filed Outline of Production, a live virus vaccine shall meet the applicable requirements in this section. (a) (2) (3) (i) Salmonella contamination as prescribed in § 113.30; and (ii) Lymphoid leukosis virus contamination as prescribed in § 113.31; and (iii) Hemagglutinating viruses as prescribed in § 113.34. (4) (b) (c) (1) (2) (d) (e) (2) Final container samples of completed product from each serial or subserial must be tested for moisture content in accordance with the test prescribed in § 113.29.

official document · source cfr-2024 · id 9:§ 113.300