Qualified Person Bardi

Qualified Person
Bardi
Emilia Romagna, Bardi

Acting as liaison between the Plant and the National Public Health Authorities (AIFA, UCS), National Public Safety Authority (Police, National Exercise and tax crimes authority, ASL) in regard of drugs and controlled drugs. Assure that each batch of drug is produced and controlled in compliance with current laws and with conditions defined in the product marketing authorization. Assure that each batch of drug coming from a country not belonging to the European Union is properly analyzed, that a quantitative analysis of all active principles is made and that any other test necessary to assure the quality of products is made, in compliance with what indicated in the product marketing authorization, reserved the right of what defined by mutual agreements. Certify and attest on specific documentation that each batch is produced in compliance with the provisions indicated in the product marketing authorization. Release the finished products for the market(Batch Release). Authorize the unpacked products release for the delivery to clients. Guarantee that all documentation required by law and by GMP is properly compiled and filed for the right period of time. Communicate immediately to AIFA and to the Company any substantial irregularity in the products already launched in the market. Collaborate actively in occasion of each inspection by Health Autorithies and guarantee that any action requested by the Authorities during the inspection is made. To monitor the Plants hygiene conditions. Certify that the pharmacologically active substances used within the plant have been produced in compliance with GMP. The QP, in order to carry out his role, avails himself of the staff settled in the legislative decree 219/06 and in the EU GMP Vol.

4 (specifically:

Experience in Quality Control in a Pharmaceutical production site (according to article 52 of 219/06 legislative decree). Proven Track Record in the pharmaceutical production fieldPrevious experience in Vaccines