Glossary

Reprocessing

Returning an intermediate or API that does not conform to standards or specifications to a defined process step and repeating the established process.

Source · ICH Q7, §20 Glossary, Reprocessing

Related sections

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

Related terms

Reworking22 casesDeviation952 casesCorrective and Preventive Action (CAPA)52 cases

Real inspection findings

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

  1. Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics are not written.
    FDA · FDA 483 · 2019-09-30
  2. Reprocessing procedures lack the steps to be taken to ensure that reprocessed batches will conform with all established standards, specifications, and characteristics.
    FDA · FDA 483 · 2025-09-04
  3. Reprocessing was performed without the review and approval of the quality control unit.
    FDA · FDA 483 · 2026-10-19
See 37 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, Reprocessing

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