EMA · Programme report
EMA reports on international API inspection cooperation
Official source date: · Source checked
The report covers 2017–2024 and describes how information sharing helps coordinate GMP oversight and reduce duplicate inspections. The programme grew from 10 to 13 participating authorities.
Who should review this?
API manufacturers, supplier-quality teams and regulatory affairs professionals.
What it means for pharmaceutical teams
Inspection cooperation concerns how authorities share oversight information. A programme-level report does not establish the compliance status of an individual supplier or replace a site-specific qualification decision.
Practical review checklist
PharmaEdges reading prompts for your own applicability review:
- Identify which authorities oversee your API supply chain.
- Read the report alongside the current inspection and qualification records for your suppliers.
- Keep programme findings separate from evidence about any individual manufacturing site.
Official source and verification
Read the EMA source (opens in a new tab)
This article summarises the linked official material. The context and checklist are PharmaEdges explanatory commentary, not additional regulatory requirements. The source publication date is separate from this article’s publication date.
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