书面报告的基本要求.ppt

Written Reporting: The Establishment Inspection Report (EIR) Mock Inspection:Written Report Each Team will prepare a written inspection report Team Leader is responsible for assignments to Team Members, for coordinating the writing of the report, for editing the report, and for ensuring that the written report is completed and submitted by the due date: Monday 14 March Following faculty review of the written reports, a teleconference will be arranged between faculty (FDA and SFDA) and Team Leaders at a subsequent date to discuss the written mock inspection reports Objectives of the Written Report -1- Supply necessary background for the reader Especially background on the inspected party/site Document what the inspector/Team examined during the inspection (extent of inspection) Document what was observed during the inspection Listing and evidence (exhibits) of any GCP/regulatory violations Objectives of the Written Report -2- Document any response(s) from the inspected party Provide preliminary conclusions/ recommendations about GCP compliance and any proposed follow-up actions For review and concurrence (or alternate opinion) by inspector’s/Team’s supervisor(s) and, as applicable, application review officials How Lengthy a Report ? Long enough to address the objectives No longer than necessary to adequately cover the objectives Even when there are no GCP violations, certain information should always be documented More/More Serious Violations = Longer/More Detailed Report General Approach to Report Writing The EIR is generally prepared after the inspection, but parts of the report can be written as the inspection proceeds Be sure to review the reporting format before and during the inspection to avoid “forgetting something” while on inspection Write the report in the first person (“I”; “me”) Keep the report factual, objective, and free of unsupportable conclusions What Should be Covered in Every Written Report Administrative information Reason for the inspecti