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External References

Type Reference Content
web github.com Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions
web en.wikipedia.org Both Bundle.link and Bundle.entry.link are defined to support providing additional context when Bundles are used (e.g. HATEOAS ).
web github.com 3.2.P.5.2 Analytical Procedures
web github.com 3.2.S.4.2 Analytical Procedures
web github.com 3.2.P.5.4 Batch Analyses
web github.com 3.2.S.4.4 Batch Analyses
web github.com 3.2.P.3.2 Batch Formula
web github.com 3.2.P.2.6 Compatibility
web github.com 3.2.P.1 Description and Composition of the Drug Product
web github.com 3.2.S.5 Reference Standards or Materials (3.2.P.6 Reference Standards or Materials is similar.)
web github.com 3.2.P.7 Container Closure System
web github.com 3.2.S.6 Container Closure System
web database.ich.org The Quality sections of regulatory applications are organized into a table of contents that includes sections and sub-sections under the titles “Drug Substance” and “Drug Product”. The structure is defined in the ICH Common Technical Document for the Registration of Pharmaceuticals for Human Use . This Common Technical Document (CTD) structure is designed for unstructured PDF and Word documents.
web github.com 3.2.P.5.1 Specification(s)
web github.com 3.2.S.4.1 Specification
web github.com 3.2.P.2.2 Drug Product
web github.com 3.2.P.2.5 Microbiological Attributes
web github.com 3.2.P.4.5 Excipients of Human or Animal Origin
web github.com 3.2.P.4.6 Novel Excipients
web github.com 3.2.S.1.3 General Properties
web github.com 3.2.S.3.1 Elucidation of Structure and Other Characteristics
web github.com 3.2.P.5.5 Characterisation of Impurities
web github.com 3.2.S.3.2 Impurities
web github.com 3.2.P.3.3 Description of Manufacturing Process and Process Controls
web github.com 3.2.S.2.2 Description of Manufacturing Process and Process Controls
web www.accumulus.org https://www.accumulus.org/wp-content/uploads/2022/05/Accumulus_Logo_horizontal.png
web github.com 3.2.P.3.1 Manufacturer(s)
web github.com 3.2.S.2.1 Manufacturer(s)
web github.com 3.2.P.3.5 Process Validation and/or Evaluation
web github.com 3.2.P.3.5 Process Validation and/or Evaluation - Biologic Example
web github.com 3.2.S.2.5 Process Validation and/or Evaluation
web github.com
Source Data (CTD PDF)
📄 3.2.P.8.1 Summary & Conclusions 📄 3.2.P.8.3 Stability Data
web github.com
Source Data (CTD PDF)
📄 3.2.P.8.1 Summary & Conclusions 📄 3.2.P.8.3 Stability Data
web github.com
Source Data (CTD PDF)
📄 3.2.S.7.1 Summary & Conclusions 📄 3.2.S.7.3 Stability Data
web github.com
Source Data (CTD PDF)
📄 3.2.S.7.1 Summary & Conclusions 📄 3.2.S.7.3 Stability Data

Internal Images

../assets/images/001.svg
../assets/images/001.svg
FHIR_Data_Pipeline_PQ_Industry_840.png
FHIR_Data_Pipeline_PQ_Industry_840.png
all-domains-dx-PQ.png
all-domains-dx-PQ.png
analytical procedures.png
analytical procedures.png
batch_analysis_FHIR_resources.png
batch_analysis_FHIR_resources.png
compatibility_FHIR_resources.png
compatibility_FHIR_resources.png
container_closure_substance.png
container_closure_substance.png
container_closure_system.png
container_closure_system.png
general_properties_substance.png
general_properties_substance.png
identification_FHIR_resources.png
identification_FHIR_resources.png
impurities_FHIR_resources.png
impurities_FHIR_resources.png
impurities_substance_resources.png
impurities_substance_resources.png
manufacturing_process_FHIR_resources.png
manufacturing_process_FHIR_resources.png
microbial_attributes_resources.png
microbial_attributes_resources.png
organizations_FHIR_resources.png
organizations_FHIR_resources.png
pharm_industry_timeline.png
pharm_industry_timeline.png
process_validation_FHIR_resources.png
process_validation_FHIR_resources.png
product_batch_formula.png
product_batch_formula.png
product_batch_info.png
product_batch_info.png
product_description_and_composition.png
product_description_and_composition.png
product_excipients.png
product_excipients.png
reference_standards_substance_resources.png
reference_standards_substance_resources.png
resources overview (complete).png
resources overview (complete).png
specification_FHIR_resources.png
specification_FHIR_resources.png
stability-pipeline-overview.png
stability-pipeline-overview.png
stability_FHIR_resources.png
stability_FHIR_resources.png
stability_substance_FHIR_resources.png
stability_substance_FHIR_resources.png
substance_analytical_procedures.png
substance_analytical_procedures.png
substance_batch_analysis_resources.png
substance_batch_analysis_resources.png
substance_batch_info_resources.png
substance_batch_info_resources.png
substance_characterization_resources.png
substance_characterization_resources.png
substance_manufacturing_process_resources.png
substance_manufacturing_process_resources.png
substance_process_validation_resources.png
substance_process_validation_resources.png
substance_specification_resources.png
substance_specification_resources.png
tree-filter.png
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