EFPIA Report on Current Inspections

The EFPIA has published its "Annual Regulatory GMP/GDP Inspection Survey 2024 Data", containing some interesting results that not everyone may have expected.

Since 2003, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has conducted member surveys on inspections. These surveys aim to provide an up-to-date overview of the type and scope of GMP inspections carried out at member companies' manufacturing sites. In recent years, the survey has also included GDP inspections. The latest edition, the "Annual Regulatory GMP/GDP Inspection Survey 2024 Data", has now been published and offers valuable insights-particularly regarding post-pandemic developments.

For example, the total number of inspections has increased, primarily due to a larger number of regulatory authorities conducting inspections. While the USA, EU, and Japan still carry out the majority of foreign inspections, other regions are increasing their inspection activities abroad. The number of foreign inspections at manufacturing sites has even slightly declined post-pandemic and is approaching pre-pandemic levels again. However, individual sites have been inspected more frequently.

The number of inspections conducted by the US FDA has decreased, even compared to 2023. Interestingly, Japan carried out the highest number of inspections within the EU/EEA.

Remote assessments continue to decline, while on-site inspections are on the rise-though they have not yet returned to pre-pandemic levels.

Experience with Expiring GMP Certificates

67% of the surveyed companies applied to their health authorities for an extension of an expired GMP/GDP certificate, which did not result in a new inspection. This was partly due to reliance on inspections by other regulatory authorities and extensions of GMP certificate validity periods (e.g., to five years).

But see for yourself: Annual Regulatory GMP/GDP Inspection Survey 2024 Data