Leptospira Hardjo Bacterin shall be produced from a culture of Leptospira hardjo which has been inactivated and is nontoxic. Each serial of biological product containing Leptospira hardjo fraction shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.
Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.
Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.
Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency using the test written into the filed Outline of Production.
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