Including the selection and preparation of main raw materials, product production technology, product analysis performance, positive judgment value or reference interval, product stability, etc.
Quality management standards for drug non-clinical research (for Trial Implementation)
The terms used in this specification are defined as follows:
1. Non-clinical research: refers to various toxicity tests conducted by the experimental system under laboratory conditions to evaluate drug safety, including single-dose toxicity test, repeated-dose toxicity test, reproductive toxicity test, mutagenic test, carcinogenic test, various stimulation tests, dependence test and other toxicity tests related to drug safety evaluation.
2. Non-clinical research institutions: refers to units engaged in non-clinical research of drugs, including safety research centers, safety research institutes, safety research laboratories or research groups.
3. Experimental system: refers to animals, plants, microorganisms and cells used for toxicity test.
4. Quality assurance department: refers to the department in the non-clinical research institution that is responsible for ensuring that all the work of the institution meets the requirements of this specification.
5. Project leader: refers to the person responsible for organizing and implementing a certain research work.
6. Test article: refers to drugs that have not been clinically studied or substances to be developed into drugs.
7. Reference substance: refers to drugs and other products used in non-clinical research to establish the basis for comparison with the test article.
8. Original data: refers to the original observation records and related documents and materials that record the research work, including work records, notebooks, various photos, microfilms, microforms, computer printed materials, magnetic carriers, and automatic instrument records.
9. Specimen: refers to any material collected from the experimental system for analysis, observation and determination.
10. Entrusting unit: refers to the unit that entrusts non-clinical research institutions to conduct non-clinical research on drugs developed by them.
1 1. Batch number: refers to a set of numbers or letters plus numbers used to identify the batch, and is used to trace back and review the history of the batch of test products or reference substances.