GMP/GDP Inspections: Challenges and Opportunities from COVID-19

ABSTRACT

Notably, pre-approval inspection (PAI) includes the added evaluation of authenticity of submitted data and link to dossier (1). Since 2003, EFPIA has conducted and reported an annual survey of good manufacturing practice (GMP) and good distribution practice (GDP) inspections and related International Organization for Standardization (ISO) audits to monitor inspection activity and trends in research-based industry (2-4). [...]the number of manufacturing sites without an inspection (domestic or foreign) was in the same range as in previous years (36% in 2020;26% in 2019;31% in 2018 [4]). [...]the regulatory oversight of manufacturing sites is consistent. Some key company responses from the survey questions include the fact that there was no change in the number and severity of observations reported;no significant differences in the outcome of GMP/GDP inspections or ISO-audits were reported;more than 90% of companies stated that there was no change in the number or type of observations;some shifts in observations were described by individual companies;and no challenges regarding drug shortage prevention measures were reported. [...]with paper-based inspections, some companies reported the start and end date of a paper-based inspection, even if the days in between were not used. [...]the duration of paper-based inspections was