Glossary
Batch Release
Also writtenlot release
The process of reviewing a batch's manufacturing and testing records and its compliance with requirements, and then approving it for sale.
Source · PIC/S PE 009-17, Annex 16, Authorised Person and Batch Release
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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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 -
In addition, your firm failed to establish adequate written responsibilities and procedures for: • Batch release •…
FDA · FDA Warning Letter · 2022-03-22 -
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
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
PIC/S PE 009-17, Annex 16, Authorised Person and Batch ReleaseGRM Regulatory Glossary
243 GMP terms in one place
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