Pharmaceutical Quality (Industry)
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Analytical Procedures

Details about test methods used to analyze substances and products, including compendial and non-compendial testing.

Product

Resources

MedicinalProductDefinitionThe drug product (Stelbat tablets, 20mg)
SubstanceDefinitionSubstances used during the analysis process
PlanDefinitionDescribes the analysis process
SpecimenDefinitionDescribes the storage conditions and duration for each test
Observation DefinitionEach individual analysis test and acceptance criteria; also used to group tests

Examples

CTD section synthetic source data samples (PDF):

XML and JSON examples of synthetic quality data:

HTML presentation examples of synthetic quality data:

Substance

Resources

SubstanceDefinitionSubstances to be analyzed and also ones used during the analysis process
PlanDefinitionDescribes the analysis process
DeviceDefinitionDevices/equipment used during testing
SpecimenDefinitionDescribes the storage conditions and duration for each test
Observation DefinitionEach individual analysis test and acceptance criteria; also used to group tests

Examples

CTD section samples (PDF):

XML and JSON examples of synthetic quality data:

HTML rendering of synthetic quality data:

Profiles

See Artifacts Index: Domain Bundle Profiles