13/14 December 2023
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has been conducting member surveys on inspections since 2003. These are intended to provide an up-to-date overview of the type and scope of GMP inspections carried out at the production sites of member companies. The surveys now also include GDP inspection and ISO certifications. Now the EFPIA has published the "Annual Regulatory GMP/GDP Inspection Survey 2021 Data". Especially with regard to the pandemic, this contains interesting data.
For example, the number of inspections at production sites in 2021 was similar to the number before the pandemic. The trends also triggered by the pandemic continue. Thus, the number of domestic inspections is rising again, while foreign inspections are still low. All types of inspections were carried out (PAI, routine, for cause, etc.) and different inspection tools were used (from purely virtual, to combinations, to completely on-site).
The data suggests that virtual tools such as remote assessments and on-site inspections require a similar inspection duration. However, little consideration was given to the actual time required for preparation on both sides.
But see for yourself: Annual Regulatory GMP/GDP Inspection Survey 2021 Data