Glossary

Batch Release

The process of reviewing a batch's manufacturing and testing records and its compliance with requirements, and then approving it for sale.

Related sections

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

Related terms

Authorized Person105 casesBatch Records77 casesFinished Product411 cases

Real inspection findings

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

  1. Critical finding #2: The extent to which SPL communicates significant product quality-related issues with the EU batch release site and EU authorities is not sufficient.
    EMA · EU GMP NCR (EudraGMDP) · 2026-03-30
  2. In addition, your firm failed to establish adequate written responsibilities and procedures for: • Batch release •…
    FDA · FDA Warning Letter · 2022-03-22
  3. Your firm failed to adequately test hand sanitizer drug products for potential microbial contamination prior to batch release.
    FDA · FDA Warning Letter · 2024-07-16
See 25 findings that mention this term

Source

PIC/S PE 009-17, Annex 16, Authorised Person and Batch Release
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