Glossary
Raw Material
A general starting material intended for use in producing an intermediate or an API.
Source · ICH Q7, §20 Glossary, Raw Material
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Your firm failed to perform adequate testing of incoming raw materials including active pharmaceutical ingredients and high-risk components such as glycerin.
FDA · FDA Warning Letter · 2024-08-06 -
For example, when we requested whether you perform raw material identity testing, you replied that the testing is done by your supplier.
FDA · FDA Warning Letter · 2021-01-26 -
Specifically, when we requested whether you perform raw material identity testing, you stated that you identify the raw material by checking the certificate of…
FDA · FDA Warning Letter · 2023-11-21
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, Raw MaterialGRM Regulatory Glossary
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