Glossary
Bulk Product
Product that has completed every processing stage except final packaging.
Source · MFDS, 「알기 쉬운 GMP 용어집」, Bulk Product Korean original
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Your response is inadequate because your firm did not provide a procedure describing how you will ensure your finished drug products, not only the bulk products, meet the appropriate quality standards prior to release.
FDA · FDA Warning Letter · 2026-09-29 -
The company manufactures exclusively non-sterile bulk products.
EMA · EU GMP NCR (EudraGMDP) · 2025-10-23 -
You have not established written procedures that describe the manufacture of ActivePro™, which was described to FDA investigators during the inspection as being manufactured from ActiveShot™ and ActiveFlow™ final bulk products.
FDA · FDA Warning Letter · 2022-06-28
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」, Bulk Product Korean originalGRM Regulatory Glossary
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