Glossary
Batch (or Lot)
A defined quantity produced in a process or series of processes and expected to be homogeneous within specified limits.
Source · ICH Q7, §20 Glossary, Batch (or Lot); MFDS, 「알기 쉬운 GMP 용어집」, Batch Korean original
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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You failed to perform analytical and microbiological release testing for each batch of your over-the-counter (OTC) topical drug products prior to distribution, including Xpasmo Manteca de Ubre (Cow’s Udder…
FDA · FDA Warning Letter · 2023-02-28 -
Without testing each batch prior to release, you did not have scientific evidence that all oral drug product batches…
FDA · FDA Warning Letter · 2025-11-18 -
In response to our request for a list all batches in stability and a list of all stability studies, you did not provide adequate stability data to demonstrate that the chemical properties of your drug products…
FDA · FDA Warning Letter · 2021-03-16
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, Batch (or Lot); MFDS, 「알기 쉬운 GMP 용어집」, Batch Korean originalGRM Regulatory Glossary
243 GMP terms in one place
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