Assessment of the adequacy and adaptation of a local network document management system to gmp annex 11

Abstract

Background & Aim Current Good Manufacture Practices (cGMP) specific for Advanced Therapy Medicinal Products (ATMPs) must be still in compliance with Annex 11 of the traditional GMP guidelines. The Quality Management System, in academic and research institutions, is not commonly supported on specially designed computerised systems in compliance with the mentioned guidelines, data integrity and traceability for appropriate Good Documentation Practice. ATMP manufacturers must figure out effective measures to overcome this situation. The aim of this study was to analyze the adequacy status of the local network consisting of a virtual shared folder for the handling of the document management system in the Cell Manufacturing Unit of the Regional University Hospital of Malaga (Spain), pointing out vulnerable features and establishing risk mitigation measures that would help to be in compliance with Annex 11. Methods, Results & Conclusion Quality Risk Management (QRM) process based on Failure Mode Effects Analysis (FMEA) was performed to the local network document management system for identification, analysis and characterization of potential risks, in terms of data integrity and traceability, in order to provide rational risk control measures that would ultimately result in overall risk reduction. An initial risk assessment was done by checking relevant features derived from Annex 11. Each non-compliant statement was individually assessed and a score based on Risk Priority Numbers (RPN) was provided. Finally, risk mitigation measures were implemented and subsequently evaluated to verify the risk reduction efficacy. Detected potential risks and implemented corrective measures are showed in Table 1. Adopted corrective measures led to a significant reduction of the RPN values after their implementation and re-assessment. A notorious improvement in the local network document management system regarding quality and data integrity has been achieved.Traditional local networks consisting of virtual shared folders can be used in the context of Good Documentation Practices in compliance with Annex 11, as long as effective measures are established and reported to assure data integrity. Data traceability still remains a problem unless a specific software solution is acquired.