FDA检查评分标准.pdfVIP

Accredited Person Inspection Program Rating Criteria Cover Sheet Background Each of the 8 elements was assigned a weight agreed upon by the Food and Drug Administrations (FDA’s) Third Party Recognition Board (TPRB) in conjunction with the Center for Devices and Radiological Health (CDRH) Senior Staff. Each applicants package will be assessed by the TPRB. After assessment by the TPRB each of the 8 elements will be voted a quality level” score from 0-4; 0 = Unsatisfactory, 2= Satisfactory, and 4= Exceeds. Each element has been assigned a weight of 5, 15 or 20. The weight of the element is based on how essential the information in the element is, in determining if the applicant is suitable to perform Quality System/Good Manufacturing Practices (QS/GMP) inspections on behalf of FDA. Quality Level Score x Weight = Element Score. The 8 element scores will be totaled to yield an Application Rating (maximum rating attainable is 400). TPRB will rank the applications (highest application rating first). MDUFMA requires that no more then 15 persons be accredited during the 12 months that follows the publication of this guidance. Definition of Acceptance Level Score Exceeds = (4) A rating of Exceeds is determined for an element when all items within an element are Satisfactory and at least 50% are substantially above the standard. Satisfactory = (2) A rating of Satisfactory is determined for an element when processes for adequately accomplishing the requirements are fully explained and supporting documentation confirms the process. Unsatisfactory = (0) A rating of unsatisfactory is determined for an element when the process for accomplishing the requirement is inadequate, not clearly and fully explained or supporting documentation is missing/incomplete. Quality Level Score x Weight= Element Score Shaded Areas to be Completed by TPRB ACCREDITED PERSON INSPECTION PROGRAM RATING CRITE