Who has to write the QOS? Can the expert be a person from the manufacturing company?

The experts must have the necessary technical or professional qualifications. According to the requirements of CTD, the experts have to sign and add a brief information on their educational background and specific expertise. The professional relationship of experts to the applicant should be declared; no restrictions to personal from the parties involved are made.

Please note that there is no list of experts accredited by the EDQM; the list published for information in the Certification section concerns only assessors involved in the Certification Procedure for the evaluation of the dossiers.