Thursday, 9 February 2023 9 .00 - 17.00 h
Following the delayed 2019 Annual Report of the Good Clinical Practice Inspectors’ Working Group (GCP IWG) published earlier this year, the EMA released the 2020 and 2021 annual reports. The delay in the publication of the 2020 report is due to the Agency’s Business Continuity Plan and prioritisation of activities for the COVID-19 pandemic.
In 2020, seven CHMP requested GCP inspections were conducted remotely, and three inspections were conducted in a hybrid setting (part on-site, part remotely). A total of 363 deficiencies, comprising 16 critical, 200 major and 147 minor findings were recorded for the 34 CHMP requested inspections conducted in 2020. The majority of findings was related to "Trial Management" (e. g. Monitoring, Data Management, Document Control, CSR, Audit) followed by "General" (e. g. Source Documentation, Qualification/Training, SOPs, Contracts/Agreements) and "IMPs" (e. g. Manufacturing/ Packaging/ Labelling). In addition, the GCP IWG published the following Q&As:
In 2021, three CHMP requested GCP inspections were conducted entirely remotely, and three inspections were conducted in a hybrid setting. A total of 286 deficiencies, comprising 24 critical, 152 major and 110 minor findings were recorded for the 27 CHMP requested inspections conducted in 2021. This represents an average of 10-11 findings per site inspected. The three top categories were: "General", "Trial Management" and "Computer System". An increase in findings related to computer systems (e. g. Audit Trail and Authorized Access, Computer Validation, Physical Security System and Backup) is noted compared to the last reports.
In addition, the GCP IWG published the following Q&As:
More information is available at EMA´s Good Clinical Practice Inspectors Working Group website.