![]() All determinations of relative antigen content using parallel line immunoassays or equivalent methods shall be conducted with an unexpired reference. ![]() (d ) Extending the dating of a reference. The evaluation of such products shall be made in accordance with the following criteria: On the basis of the results of such test procedures, each serial that meets the required minimum potency shall be released to the firm for marketing each serial not meeting the required minimum potency shall be withheld from the market. Firms currently using immunoassays which do not satisfy this requirement shall have 2 years from the effective date of the final rule to update their filed Outlines of Production to be in compliance with this requirement unless granted an extension by the Administrator based on a showing by the firm seeking the extension that they have made a good faith effort with due diligence to achieve compliance. (c ) In the case of inactivated products, bulk or final container samples of completed product from each serial derived from an approved Master Seed, shall be evaluated for relative antigen content (potency) as compared with an unexpired reference by a parallel line immunoassay or other procedure acceptable to APHIS. When the initial sample is not representative of final packaging by the licensee of permittee, e.g., does not consist of all the microtiter test plates or strips, the second sample is not eligible to be returned to serial inventory after the serial is released. In the case of diagnostic test kits in which final packaging consists of multiple microtiter test plates or strips, the licensee or permittee may submit a specified number of test plates or strips along with all other test reagents as prescribed in a filed Outline of Production and retain a similar amount as a second sample for submission upon request. If submission is not requested by the Animal and Plant Health Inspection Service, the additional sample may be returned to the serial inventory after the serial is released. The licensee or permittee will hold one of these selected samples at the storage temperature recommended on the label while awaiting a request by the animal and Plant Health Inspection Service to submit the additional sample. ![]() (7 ) Diagnostic test kits: Two samples of diagnostic test kits. Products for treatment of failure of passive transfer. General requirements for antibody products.Ĭlostridium Perfringens Type C Antitoxin.Ĭlostridium Perfringens Type D Antitoxin. General requirements for live virus vaccines.Ĭanine Hepatitis and Canine Adenovirus Type 2 Vaccine. General requirements for killed virus vaccines.Įncephalomyelitis Vaccine, Eastern, Western, and Venezuelan, Killed Virus.Īvian Encephalomyelitis Vaccine, Killed Virus.įeline Calicivirus Vaccine, Killed Virus.īovine Virus Diarrhea Vaccine, Killed Virus.īovine Rhinotracheitis Vaccine, Killed Virus. Pasteurella Multocida Bacterin, Avian Isolate, Type 3. Pasteurella Multocida Bacterin, Avian Isolate, Type 1. Pasteurella Multocida Bacterin, Avian Isolate, Type 4. General requirements for inactivated bacterial products.Ĭlostridium Botulinum Type C Bacterin-Toxoid.Ĭlostridium Perfringens Type C Toxoid and Bacterin-Toxoid.Ĭlostridium Perfringens Type D Toxoid and Bacterin-Toxoid. Pasteurella Multocida Vaccine, Avian Isolate.Ĭhlamydia Psittaci Vaccine (Feline Pneumonitis), Live Chlamydia. General requirements for live bacterial vaccines. Requirements for ingredients of animal origin used for production of biologics.ĭetection of extraneous agents in Master Seed Virus. Requirements for cell lines used for production of biologics. Requirements for primary cells used for production of biologics. Testing of bulk material for export or for further manufacture.Ĭulture media for detection of bacteria and fungi.ĭetection of viable bacteria and fungi except in live vaccine.ĭetection of extraneous viable bacteria and fungi in live vaccines.ĭetermination of moisture content in desiccated biological products.ĭetection of pathogens by the chicken inoculation test.ĭetection of pathogens by the chicken embryo inoculation test.ĭetection of lymphocytic choriomeningitis contamination.ĭetection of cytopathogenic and/or hemadsorbing agents.ĭetection of extraneous viruses by the fluorescent antibody technique. Animal and Plant Health Inspection Service testing.
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