*NOTE: Level of non-compliance to be shown as: CRITICAL, MAJOR, or MINOR # NOTE: Where the same non-conformance was identified at the previous audit, or not adequately addressed. of Non-conformance Score and Audit Rating: # Auditor’s calculation Please refer to the for full information on the calculation of audit ratings and NC scores. Step 1: Number of Non-conformances Non-conformance unit value Calculated Non-conformance Score Critical Audit Level 4 (see below) N/A ► ► Major 4 Minor 1 Total NC Score ► Step 2: Audit Result Audit Rating # Manufacturer (please select one) eligible for closure Number of Major NC Score by plan? NCs 0 0 to 4 Audit Level 1 Yes No more than 5 5 to 20 Audit Level 2 Yes No more than 10 21 to 40 Audit Level 3 No More than 10 Greater than 40 Audit Level 4 No
*NOTE: Level of non-compliance to be shown as: CRITICAL, MAJOR, or MINOR # NOTE: Where the same non-conformance was identified at the previous audit, or not adequately addressed. Auditor’s calculation of Non-conformance Score and Audit Rating: # Please refer to the for full information on the calculation of audit ratings and NC scores. Step 1: Number of Non-conformances Non-conformance unit value Calculated Non-conformance Score Critical N/A ► ► Audit Level 4 (see below) Major 4 Minor 1 Total NC Score ► Step 2: Audit Result Audit Rating # (please select one) Manufacturer eligible for closure by plan? Number of Major NCs NC Score 0 0 to 4 Audit Level 1 Yes No more than 5 5 to 20 Audit Level 2 Yes No more than 10 21 to 40 Audit Level 3 No More than 10 Greater than 40 Audit Level 4 No
fm-mql05-gmp-audit-report.docx