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^{Table 1 Footnote 1} used in this type of manufacturing
Chemical Manufacturing	Production of the API Starting Material	Introduction of the API Starting Material into process^{Table 1 Footnote 1}	Production of Intermediate(s)^{Table 1 Footnote 1}	Isolation and purification^{Table 1 Footnote 1}	Physical processing, and packaging^{Table 1 Footnote 1}
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^{Table 1 Footnote 1}	Isolation and purification^{Table 1 Footnote 1}	Physical processing, and packaging^{Table 1 Footnote 1}
API extracted from plant sources	Collection of plants	Cutting and initial extraction(s)	Introduction of the API Starting Material into process^{Table 1 Footnote 1}	Isolation and purification^{Table 1 Footnote 1}	Physical processing, and packaging^{Table 1 Footnote 1}
Herbal extracts used as API	Collection of plants	Cutting and initial extraction	N/A	Further extraction^{Table 1 Footnote 1}	Physical processing, and packaging^{Table 1 Footnote 1}
API consisting of comminuted or powdered herbs	Collection of plants and/or cultivation and harvesting	Cutting/ comminuting	N/A	N/A	Physical processing, and packaging^{Table 1 Footnote 1}
Biotechnology: fermentation/ cell culture	Establishment of master cell bank and working cell bank	Maintenance of working cell bank^{Table 1 Footnote 1}	Cell culture and/or fermentation^{Table 1 Footnote 1}	Isolation and purification^{Table 1 Footnote 1}	Physical processing, and packaging^{Table 1 Footnote 1}
"Classical" Fermentation to produce an API	Establishment of cell bank	Maintenance of the cell bank	Introduction of the cells into fermentation^{Table 1 Footnote 1}	Isolation and purification^{Table 1 Footnote 1}	Physical processing, and packaging^{Table 1 Footnote 1}
The stringency of GMP in API manufacturing should increase as the process proceeds from early API steps to final steps. Table 1 Footnote 1 This guide applies to the noted manufacturing step. Table 1 Return to footnote 1 referrer

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Date modified:: 2025-06-26