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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