EMA: Latest Report on the International GMP Inspection Programme for API Manufacturers
EMA has published a new report on the International Active Pharmaceutical Ingredient Inspection Programme, covering the period 2017–2024. During this time, the number of participating authorities increased from ten to 13. Information was shared on 936 inspected sites and 1,684 inspections. Overall, 69% of the sites were of shared interest to at least two authorities. The 644 sites of common interest were in 18 countries: 35% in China and 50% in India, 14% in the remaining 16 countries.
Inspection reliance was reported for 107 sites, for example through the review of GMP certificates or inspection reports from other authorities. In addition, 91 remote inspections were conducted. However, room for improvement remains: 32% of sites of shared interest underwent duplicate inspections within a twelve-month period. Legal requirements, confidentiality restrictions and language barriers continue to hamper the sharing and use of inspection reports.
EMA therefore recommends expanding reliance practices, improving the usability of inspection reports and establishing a secure central platform for information exchange. The report confirms that international cooperation can strengthen GMP oversight while making better use of inspection resources and reducing unnecessary duplication.
Source:
EMA: Report on the International Active Pharmaceutical Ingredient Inspection Programme 2017 – 2024
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