Glossary

Raw Material

A general starting material intended for use in producing an intermediate or an API.

Related sections

ICH Q7 Glossary ICH Q7 §§7–11

Related terms

Starting Material15 casesAPI Starting Material1 casesIntermediate109 cases

Real inspection findings

Findings from regulators' inspection documents in which this term appears.

  1. 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
  2. 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
  3. 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
See 435 findings that mention this term

Source

ICH Q7, §20 Glossary, Raw Material
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