Table 1: Application of this Guidance to API Manufacturing : Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: ICH Topic Q7A
Type of Manufacturing | Application of this Guidance to stepsTable 1 Footnote 1 used in this type of manufacturing | ||||
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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.
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