Glossary
Sterility Assurance Level (SAL)
A quantitative expression of the probability that a single viable microorganism is present on a product unit after sterilisation.
Source · MFDS, 「알기 쉬운 GMP 용어집」, Sterility assurance level; EU GMP Annex 1 Korean original
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Your firm is a manufacturer of over-the-counter (OTC) drugs for oral, nasal, rectal, and topical use.
FDA · FDA Warning Letter · 2025-10-07 -
Under section 582(c)(4)(A) & (B) of the FD&C Act, wholesale drug distributors must have systems in place to enable the wholesale distributor to comply with the verification requirements of the DSCSA.
FDA · FDA Warning Letter · 2023-06-27 -
Your firm failed to perform an investigation into the microbial contamination of (b)(4) Nasal Spray batch (b)(4) .
FDA · FDA Warning Letter · 2023-05-09
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
MFDS, 「알기 쉬운 GMP 용어집」, Sterility assurance level; EU GMP Annex 1 Korean originalGRM Regulatory Glossary
243 GMP terms in one place
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