Non-conformance

Details

ICH Q10 places nonconformance alongside complaints, product rejections, recalls, deviations, audits, and regulatory inspection findings, and requires all of them to be treated as inputs to CAPA. A nonconformance is therefore not an event that ends in itself but a signal that has to be put onto an investigation path. The corpus includes investigations of nonconformances that were not adequate, nonconformance report forms found together with pre-signed blank forms, and a corrective plan submitted to computerise nonconformance and CAPA management. EU GMP Part I 4.29 lists records of deviation and nonconformance investigations among the documents that must be held.

Related sections

Related terms

Real inspection findings

Findings from regulators' inspection documents in which this term appears.

1. Furthermore, an updated QA-0003 non-conformance procedure that prevents a batch from being released with an open nonconformance was not provided.

   FDA · FDA Warning Letter · 2023-08-08

2. For example, your QU failed to ensure: Adequate investigations into non-conformances are…

   FDA · FDA Warning Letter · 2024-09-10

3. For example, you did not review, approve, or implement procedures for critical quality operations such as handling non-conformances, change control, training management, and handling out-of-specification…

   FDA · FDA Warning Letter · 2026-04-28

Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.