Audits ensure the quality of operations
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Audits carried out between the authorities in the Joint Audit Programme (JAP) are used to ensure the appropriate supervision of the industrial manufacturing of medicines in the European Economic Area (EEA). Fimea’s Good Manufacturing Practice (GMP) monitoring was audited in the JAP programme in November 2024.
Before the audit, the auditors were provided with an extensive report on Finnish regulations and Fimea’s GMP monitoring, quality defects and laboratory practices. The on-site audit took five days, during which the auditors followed one GMP inspection performed by Fimea.
The results of Fimea’s audit are also used to maintain the Mutual Recognition Agreement (MRA) between the EU and third countries. During the audit, Fimea received a few observations to improve its GMP monitoring. The final audit report will be submitted in early 2025.
In November 2024, the national accreditation body FINAS carried out a periodic audit of the Fimea Laboratory, which included evaluating the management system, documentation and quality of operations. The deviations observed during the audit were minor, and after being corrected, the Fimea Laboratory meets the requirements set for accreditation.
The validity of the Fimea Laboratory was also audited in a Mutual Joint Audit carried out by the medicines control laboratory network in September 2024. The audit highlighted the management of operational risks and the measures ensuring impartial operation as key strengths. In addition, Fimea’s new premises were praised for their functionality.