ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Intermediate

(ICH Q7) A material produced during steps of the processing of an API that undergoes further molecular change or purification before it becomes an API. Intermediates may or may not be isolated.

(NOTE: ICH Q7 only addresses those intermediates produced after the point that the company has defined as the point at which the production of the API begins.)

Publication Source: ISPE Baseline® Guide, Vol. 6: Biopharmaceutical Manufacturing Facilities

Publication Date: 2004

Intermediate

(ICH Q3A (R2))A material produced during steps of the synthesis of a new drug substance that undergoes further chemical transformation before it becomes a new drug substance.

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Intermediate

(ICH Q5C) For biotechnological/biological products, a material produced during a manufacturing process which is not the drug substance or the drug product but whose manufacture is critical to the successful production of the drug substance or the drug product. Generally, an intermediate will be quantifiable and specifications will be established to determine the successful completion of the manufacturing step prior to continuation of the manufacturing process. This includes material which may undergo further molecular modification or be held for an extended period of time prior to further processing.

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