HTA License Conformance Analysis for Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA

The content of this page is being developed with the HTA committee, and is subject to further change. Editors are welcome to use this page to pick up errors in their definitions, but should not regard the analysis as final.

http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl (NCI Thesaurus)

Uses28
Expected Copyright(copyright expectations unknown)
Approved:To be resolved

URL Name Copyright Notes
capsule-classification-category Capsule Shell Classification Terminology
cmc-product-name-types-vs Product Name Types Terminology
pqcmc-batch-utilization-terminology Batch utilization Terminology
pqcmc-chemical-structure-datafile-type-terminology Chemical Structure Data File Type Terminology
pqcmc-closure-type-terminology Closure Type Terminology
pqcmc-coating-purpose Coating Purpose Terminology
pqcmc-container-type-terminology Container Type Terminology
pqcmc-drug-product-component-function-category-terminology Drug Product Component Function Category Terminology
pqcmc-excipient-function-terminology Excipient Function Terminology
pqcmc-impurity-classification-terminology Impurity Classification Terminology
pqcmc-manufactured-dose-form-terminology Manufactured Dose Form Terminology
pqcmc-product-part-ingredient-physical-location Ingredient Location Terminology
pqcmc-product-part-type Product Part Type Terminology
pqcmc-quality-benchmark-terminology Quality Benchmark Terminology
pqcmc-release-mechanism Release Mechanism Terminology
pqcmc-release-profile Release Profile Terminology
pqcmc-representation-types Representation Types
pqcmc-source-type-terminology Source Type Terminology
pqcmc-specification-status-terminology Specification Status Terminology
pqcmc-specification-type-terminology Specification Type Terminology
pqcmc-strength-type-terminology Strength Type Terminology
pqcmc-substance-name-type Substance Name Type
pqcmc-test-category-terminology Test Category Terminology
pqcmc-test-method-origin-terminology Test Method Origin Terminology
pqcmc-test-usage-terminology Test Usage Terminology
spl-drug-route-of-administration-terminology Drug Route Of Administration Terminology
spl-pharmaceutical-dosage-form-terminology Pharmaceutical Dosage Form Terminology
substance-classification Substance Classification

urn:ietf:bcp:13
Uses3
Expected Copyright(copyright expectations unknown)
Approved:To be resolved

URL Name Copyright Notes
pqcmc-analytical-instrument-data-types Analytical Instrument Data File Types
pqcmc-graphical-file-types Graphical File Types
pqcmc-structure-data-types Structure Data Types

http://unitsofmeasure.org (Unified Code for Units of Measure (UCUM))
Uses2
Expected Copyright(copyright expectations unknown)
Approved:To be resolved

URL Name Copyright Notes
pqcmc-percentage-units Percentage Units
pqcmc-units-of-measure Units Of Measure