The ICH quality series underpins much of what EU GMP expects. Q9 and Q10 are reproduced in EudraLex Volume 4 Part III, which makes them directly relevant rather than merely informative.
ICH produces harmonised guidelines adopted by regulators. It is not itself a regulator and does not inspect or authorise.
Official sitePublished by ICH. Verify current status at the source.
The basis for EU GMP Part II. Applying Part I requirements to an API operation is a common and confusing scoping error.
Read the full articlePublished by ICH. Verify current status at the source.
Q8 on pharmaceutical development, Q9 on quality risk management, Q10 on the pharmaceutical quality system and Q12 on lifecycle management are the ones that appear most often in GMP discussions.
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.