PLAZMACENTRUM Korlátolt Felelősségű Társaság / PLAZMACENTRUM Kft. — EU GMP NCR (EudraGMDP) Findings

During the inspection performed on 1-2 June 2021 at Plazmacentrum Budapest 3 critical (n=3) deficiencies were identified in total and several other deficiencies as major. Plazmacentrum showed lack of ability to adhere to the principles of Good Manufacturing Practice. Plazmacentrum did not sufficiently ensured the safety and traceability of the product as summarized by the 3 critical deficiencies: 1. Handling of rejected plasma units assigned for disposal due to biohazard risk was not safe. There was no physical segregation of rejected plasma units (for instance units from infected donors) in the freezer, the labelling was misleading, there was no clearly written instruction for the disposal. 2. The IT software used for plasma management was not validated according to the complexity of the system. The incorrect categorization and validation led to inadequate data governance, eg. the migration of data from previous software did not happen in a controlled way, the audit trail could not be accessed by the company, therefore the data integrity was compromised. 3. The paper based records - that contain raw data - were not archived in a controlled dedicated place. There was no inventory indicating the location of the records, the long term (30 years) traceability of the donor and donation via the blood establishment through to the batch of medicinal product and vice versa was not ensured. Major deficiencies were identified in connection with: - vendor management (eg., vendor selection and approval, very poor technical aspects of contracts) - inappropriate identification and storage of GMP materials - insufficient documentation practice Action taken/proposed by the NCA: Suspension of the manufacturing authorisation No. HU-M-PLCT in Full Withdrawal, of current valid GMP certificate No. 17294-8/2018 GMP certificates invalidated Prohibition of supply No recall is necessary. Plasma units currently stored in the manufacturer’s freezer should be placed in quarantine until further notice.