Glossary

Reworking

Out of specification Established process Different steps Acceptable
Illustration

Subjecting material that does not conform to specification to one or more processing steps different from the established process, in order to make it acceptable.

Source · ICH Q7, §20 Glossary, Reworking

Related sections

ICH Q7 §§10, 14–15 EU GMP Part I Chapter 4 EU GMP Part I Chapter 8

Related terms

Reprocessing37 casesDeviation952 casesChange Control523 cases

Real inspection findings

See 22 findings whose text contains this term

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

Source

ICH Q7, §20 Glossary, Reworking

GRM Regulatory Glossary

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