(2003; 148 pages)
2.6 Report and outcome of evaluation
The evaluators and inspection team(s) will finalize a report according to the established WHO format describing the findings and including recommendations to the manufacturers. This will be communicated to the manufacturers.
If any additional information is required, or corrective action has to be taken by the manufacturer, WHO will postpone its final recommendations until such information has been evaluated, or the corrective action has been taken and found satisfactory in light of the specified standards.
In the event of any disagreement between a manufacturer and WHO, an SOP established by WHO for the handling of appeals and complaints will be followed to discuss and resolve the issue.
As WHO is responsible for the quality assessment, the ownership of the reports lies with WHO (without prejudice, however, to any confidential and proprietary information of the manufacturer contained in this report).