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 stepsTable 1 Footnote 1 used in this type of manufacturing
Chemical Manufacturing Production of the API Starting Material Introduction of the API Starting Material into processTable 1 Footnote 1 Production of Intermediate(s)Table 1 Footnote 1 Isolation and purificationTable 1 Footnote 1 Physical processing, and packagingTable 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 processTable 1 Footnote 1 Isolation and purificationTable 1 Footnote 1 Physical processing, and packagingTable 1 Footnote 1
API extracted from plant sources Collection of plants Cutting and initial extraction(s) Introduction of the API Starting Material into processTable 1 Footnote 1 Isolation and purificationTable 1 Footnote 1 Physical processing, and packagingTable 1 Footnote 1
Herbal extracts used as API Collection of plants Cutting and initial extraction N/A Further extractionTable 1 Footnote 1 Physical processing, and packagingTable 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 packagingTable 1 Footnote 1
Biotechnology:
fermentation/
cell culture
Establishment of master cell bank and working cell bank Maintenance of working cell bankTable 1 Footnote 1 Cell culture and/or fermentationTable 1 Footnote 1 Isolation and purificationTable 1 Footnote 1 Physical processing, and packagingTable 1 Footnote 1
"Classical" Fermentation to produce an API Establishment of cell bank Maintenance of the cell bank Introduction of the cells into fermentationTable 1 Footnote 1 Isolation and purificationTable 1 Footnote 1 Physical processing, and packagingTable 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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