Requirements for ingredients of animal origin used for production of biologics.

CFR · 2024-01-01 · US · Title 9

Each lot of ingredient of animal origin which is not subjected to heat sterilization or other sterilization methods acceptable to Animal and Plant Health Inspection Service (APHIS), such as, but not limited to serum and albumin, used to prepare a biological product shall be tested as prescribed in this section by the licensee or a laboratory acceptable to VS. Results of all tests shall be recorded by the testing laboratory and made a part of the licensee's records. A lot of ingredient found unsatisfactory by any prescribed test shall not be used to prepare a biological product. A serial of biological product shall not be released if produced using an ingredient that is found unsatisfactory by any prescribed test. (a) Samples of each lot of ingredient of animal origin which is not subjected to heat sterilization, used to prepare a biological product shall be shown free of mycoplasma by the method prescribed in § 113.28. (b) Samples of each lot of ingredient or animal origin which is not subjected to heat sterilization of other sterilization methods acceptable to APHIS used to prepare a biological product shall be shown free of bacteria and fungi as prescribed in § 113.26. (c) Samples of each lot of ingredient of animal origin, except porcine trypsin, which is not subjected to heat sterilization or other viricidal procedure acceptable to APHIS used in the preparation of biological products shall be tested as prescribed in this paragraph; (1) Monolayers at least 75 cm (2) At lea

official document · source cfr-2024 · id 9:§ 113.53