药品临床前安全评价过程中供试品的GLP管理

Management of test articles for drugs pre-clinical safety evaluation complying with GLP

药品临床前安全评价过程中供试品的管理必须符合GLP规范要求。规范的GLP管理需要设立符合条件的专职管理人员;在规定的专用保存场所对供试品进行接收、保存和分发;保存条件要确保供试品的性状稳定和安全保存;其管理原则是控制保存场所的环境条件,对接收、保存和分发过程中供试品的数量和状态进行记录,做到进出平衡,确保其性状稳定。

Management of test article for drugs pre-clinical safety evaluation should ensure that the principles of Good Laboratory Practices （GLP） are complied with in the test facility. There should be a qualified person nominated by testing facility manger what fulfils the responsibility for the test article handling. Suitable and separate rooms or areas should be available for receipt, storage and distribution of the test articles. The rooms or areas with appropriate conditions should be adequate to preserve identify, concentration, purity and stability, and ensure safe storage for hazardous substance. The raw data, receipt and used quantity should be recorded to keep the balance of test article. To control the quantity balance, storage condition, distribution and using procedure should be the key principles for handling test articles complying with GLP.