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 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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