药品研究中GLP实验室实验原始记录审核技术要求龚兆龙.ppt

Major issues of data auditWhat do we look for while auditing a GLP lab Study Director Facility Management Quality Assurance Chemistry Pathology (Clinical and anatomical) Technical Staff Report writing Sponsor Accounting Subcontractors 第六十三页，共一百一十页。 非临床实验室常见错误 Study director Failure to follow protocol Most common because everything is driven by protocol. Examples: TA Stability determination Environmental conditions Exposure to test article (dosing) 第六十四页，共一百一十页。 非临床实验室常见错误 Study director (cont’d) Final Report Commonly see failures to address issues that occurred during study that could affect outcomes 第六十五页，共一百一十页。 非临床实验室常见错误 Study director (cont’d) Failure to record all data and verify Formulation Dosing 第六十六页，共一百一十页。 非临床实验室常见错误 Study director (cont’d) Documentation issues Best way, protocol amendment. Must be done before action (signed by SD and also QA, management and sponsor). Second best, deviation report (deviation from protocol or SOP). Completed after-the-fact by person making the observation (signed by SD and also QA and management). Deviation is noted in study report along with description of the impact the deviation has on study integrity. 第六十七页，共一百一十页。 非临床实验室常见错误 Inconsistencies within a protocol or between protocol and SOP Omission of necessary information from protocol Late entries in study books Non GLP corrections Failure to sign and date entries Expired reagents 第六十八页，共一百一十页。 非临床实验室常见错误 Failure to issue timely protocol amendments and deviation reports Paperwork missing from study book Inconsistencies between protocol and report or raw data and report. 第六十九页，共一百一十页。 非临床实验室常见错误 QAU fails to authorize deviation Deviations not detected by the QAU, but should have been 第七十页，共一百一十页。 非临床实验室常见错误 Transfer of data, specimens, records to archives At completion of study Not all records transferred 第七十一页，共一百一十页。 非临床实验室常见错误 Did not follow SOPs for required auditing Inappropriate training record keeping Equipment calibration issues Sanit