GLP与SOP.pptVIP

标准操作规范 STANDARD OPERATING PROCEDURES Sec. 160.81 Standard operating procedures. (a) A testing facility shall have standard operating procedures in writing setting forth study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study. All deviations in a study from standard operating procedures shall be authorized by the study director and shall be documented in the raw data. Significant changes in established standard operating procedures shall be properly authorized in writing by management. (b) Standard operat