Glossary
Starting Material
Any substance used in the production of a medicine, excluding packaging materials.
Source · MFDS, 「알기 쉬운 GMP 용어집」, Starting Material Korean original
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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- Lack of consistency and reliability of the entry in the “Batch Processing Records” for the calculation of the quantities of starting materials (including active substance) used in the manufacture of a batch of the veterinary medicinal product Strepto 37.5; powder for solution for pigs.
EMA · EU GMP NCR (EudraGMDP) · 2024-09-23 -
Your firm failed to validate or adequately verify multiple test methods used for testing key starting materials and finished APIs.
FDA · FDA Warning Letter · 2026-07-21 -
Inadequate Process Validation Your firm failed to establish adequate process validation for clomiphene citrate USP and its key starting materials.
FDA · FDA Warning Letter · 2026-07-21
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」, Starting Material Korean originalGRM Regulatory Glossary
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