General Safety Tests/Abnormal Toxicity Tests

The General Safety Tests, also known as Abnormal Toxicity Tests, are primarily utilized in the testing of biological products intended for direct administration to humans or animals. These tests are conducted for the detection of non-specific, extraneous toxic contaminants that may be present in the final filling of each lot of licensed product, such as antitoxins, antivenins, blood, blood derivatives, immune serums, immunologic diagnostic aids, toxoids, or vaccines.

Different organizations published standards for various General Safety Tests. In Europe the test was specified in EP 2.6.9, Abnormal Toxicity. In the United States, this test had previously been prescribed for biologics by 21 CFR 610.11 – General safety but since 2016 that section has been put on reserve and the section is not available in the CFR. USP contains general safety tests for in USP <88>, Biological Reactivity Tests, In Vivo. Lot release programs for certain biologics may require this test and PBL offers these tests for those programs.

Generally, these tests are short duration, single application tests to evaluate overt toxicity.  A defined amount of material is introduced into the test system and subsequently evaluated over a few days for gross evidence of toxicity, such as survival and/or body weight loss.

General Safety Testing Services

  • CFR Safety Test (for Biologics)
  • USP <88> Systemic Injection Tests
  • EP Abnormal Toxicity Tests
  • Vaccines and Immunosera Abnormal Toxicity Tests
  • USP Iron Dextran

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