KQP is a multi-step program developed by Kedrion to monitor and guarantee the safety of its products and processes.
It consists of eight steps:

1. Regular, qualified donors. Plasma is obtained from regular, qualified donors who go to transfusion centres approved and inspected by the Health Authorities.

2. Donation control. Only donated plasma which has tested negative for viruses is processed, after undergoing validated test methods, which are sensitive and specific to the pathogens listed in the reference regulations.

3. Inventory Hold. Kedrion’s Quality System allows plasma to be processed after a quarantine of at least 60 days.

4. NAT Test. To further reduce the risk of biological contamination, Kedrion has validated the nucleic acid amplification technique (NAT) for the most pathogenic viral agents: HCV, HIV, HBV, Parvovirus B19, HAV. By implementing this test procedure, small nucleotide sequences of genetic material from the aforesaid viruses can be searched for and located in the donated plasma as well as in the plasma pool to be fractionated.

5. cGMP. The production process is conducted in accordance with Good Manufacturing Practices (cGMPs - current Good Manufacturing Practices) and steadily checked, monitored and upgraded by Kedrion’s Quality System, besides undergoing regular inspections by the Authorities concerned.

6. Double viral inactivation/removal treatment. Kedrion has added to its productive process at least two viral inactivation/removal steps for each product, in order to further reduce the risk of transmission of known  (whether or not coated with a lipidic capsule) and/or unknown pathogens. These physical and chemical processes are approved by the international health authorities, as they do not alter the beneficial properties of the product. The viral inactivation/removal processes that have been adopted and validated as effective are listed below:

• solvent/detergent treatment,
• heat treatment,
• nanofiltration,
• alcoholic fractioning according to  Cohn’s method,
• acid pH treatment.

7. Batch Release . All of its plasma-derived products can only be marketed after having obtained a Certificate of Approval from Health Authorities.

8. Post-marketing surveillance. The products are further checked after they are put on the market in order to define their safety and tolerability profiles.