Table 1: Application of this Guidance to API Manufacturing : Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: ICH Topic Q7A

Table 1: Application of this Guidance to API Manufacturing
Type of Manufacturing Application of this Guidance to steps (shown in grey) used in this type of manufacturing
Chemical Manufacturing Production of the API Starting Material Introduction of the API Starting Material into process Production of Intermediate(s) Isolation and purification Physical processing, and packaging
API derived from animal sources Collection of organ, fluid, or tissue Cutting, mixing, and/or initial processing Introduction of the API Starting Material into process Isolation and purification Physical processing, and packaging
API extracted from plant sources Collection of plants Cutting and initial extraction(s) Introduction of the API Starting Material into process Isolation and purification Physical processing, and packaging
Herbal extracts used as API Collection of plants Cutting and initial extraction Further extraction Physical processing, and packaging
API consisting of comminuted or powdered herbs Collection of plants and/or cultivation and harvesting Cutting/ comminuting Physical processing, and packaging
Biotechnology:
fermentation/
cell culture
Establishment of master cell bank and working cell bank Maintenance of working cell bank Cell culture and/or fermentation Isolation and purification Physical processing, and packaging
"Classical" Fermentation to produce an API Establishment of cell bank Maintenance of the cell bank Introduction of the cells into fermentation Isolation and purification Physical processing, and packaging

Increasing GMP requirements

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