Glossary
Validation Protocol
A document fixing in advance the critical systems, attributes, and parameters to be tested in a validation, together with the methods and acceptance criteria.
Source · EU GMP Annex 15, §2.4 Validation protocols; MFDS, 「알기 쉬운 GMP 용어집」 Korean original
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Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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However, details of your plan, such as the names of the other product families and how you plan to implement these validation protocols were not provided.
FDA · FDA Warning Letter · 2025-03-11 -
We acknowledge that your firm has completed the first process validation (PV) study for Buffered Lidocaine HCI 2%, 20 mg/ml 50 ml vial and provided the protocol, also, that you initiated CAPA/PD/009/24 on 09/20/2024, provided Master Process Validation Protocol and Record of Observations.
FDA · FDA Warning Letter · 2025-07-01 -
For example, the process validation protocol for your (b)(4) drug product lacked microbiological testing and the active ingredient…
FDA · FDA Warning Letter · 2024-03-05
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
EU GMP Annex 15, §2.4 Validation protocols; MFDS, 「알기 쉬운 GMP 용어집」 Korean originalGRM Regulatory Glossary
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