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Manufacturing process description and details about unit operations, process parameters, and in-process controls.
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| MedicinalProductDefinition | The drug product (Stelbat tablets, 20mg) |
| Ingredient | The active ingredient (stelbatalol) or the ingredients that make up the drug substance or product |
| Substance Definition | Details about the substance associated with the product ingredients, or those that participate in the steps of the manufacturing process |
| Plan Definition | Describes the manufacturing process protocol. Includes "action" steps, parameters, and output criteria |
| DeviceDefinition | Information about devices/equipment used in the manufacturing |
| DocumentReference | (not shown) Link to images, about process steps for example |
CTD section synthetic source data samples (PDF):
XML and JSON examples of synthetic quality data:
HTML presentation example of synthetic quality data:
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| SubstanceDefinition | Details about the substance being manufactured, or those that participate in the steps of the manufacturing process |
| PlanDefinition | Describes the manufacturing process protocol. Includes "action" steps, parameters, and output criteria |
CTD section samples (PDF):
XML and JSON examples of synthetic CTD data:
HTML presentation example of synthetic CTD data: