Relevant where product reaches the US market, and useful comparatively: the FDA guidance on investigating out-of-specification results is the most detailed public treatment of that subject.
FDA regulates medicinal products for the US market. Its requirements apply to EU sites exporting there, in addition to EU GMP.
Official sitePublished by FDA. Verify current status at the source.
21 CFR Parts 210 and 211. Structurally different from EU GMP but converging in substance on most quality-system expectations.
Read the full articlePublished by FDA. Verify current status at the source.
Includes the guidance on investigating out-of-specification test results, which sets out the two-phase investigation more explicitly than the EU text.
Read the full articleGMPConsultant.nl is an independent advisory. It is not a regulator, a notified body or a certification body. Explanations on these pages are our interpretation, published separately from the official text so the two are never confused. Always verify against the primary source before acting — guidance is revised, and a page here may not reflect the most recent position.
Knowing what a source says is the start. The Health Index turns it into a scored position across seven domains, and the knowledge base explains where each requirement goes wrong in practice.