FDA Pharmaceutical Quality/CMC Terminology

Preferred Label : FDA Pharmaceutical Quality/CMC Terminology;

NCIt synonyms : FDA Pharmaceutical Quality/Chemistry, Manufacturing, and Controls Terminology;

NCIt related terms : PQ/CMC Terminology;

NCIt definition : A category of terminology used to qualify the information pertaining to Pharmaceutical Quality/Chemistry, Manufacturing and Controls.;

NCI Metathesaurus CUI : CL537791;

Details

Origin ID

C133805;

UMLS CUI

C4524899;

Semantic type(s)
- Intellectual Product [UMLS semantic type]
concept_is_in_subset
- FDA Terminology [NCIt concept]
subset_includes_concept
- Abbreviated New Animal Drug Application [NCIt concept]
- Abbreviated New Drug Application [NCIt concept]
- Absorption Modifying Excipient [NCIt concept]
- Active Ingredient [NCIt concept]
- Actuation Dosing Unit [NCIt concept]
- Adequate Substance Process Understanding [NCIt concept]
- Adhesive Device [NCIt concept]
- Adjuvant [NCIt concept]
- Adsorbent [NCIt concept]
- Air Displacement Agent [NCIt concept]
- Ambient Delayed Testing [NCIt concept]
- Ampule [NCIt concept]
- Animal [NCIt concept]
- Animal Sources [NCIt concept]
- Annual Report [NCIt concept]
- Antioxidant [NCIt concept]
- Applicator [NCIt concept]
- Applicator Bottle [NCIt concept]
- Applicator Tube [NCIt concept]
- Approval [NCIt concept]
- Approved Application Supplement [NCIt concept]
- Assay [NCIt concept]
- Atomic Mass Unit [NCIt concept]
- Bag [NCIt concept]
- Binder Excipient [NCIt concept]
- Biochemical Activity [NCIt concept]
- Bioequivalence Batch [NCIt concept]
- Biological Property [NCIt concept]
- Biologics License Application [NCIt concept]
- Blister Pack [NCIt concept]
- Bottle [NCIt concept]
- Box [NCIt concept]
- British Pharmacopeia [NCIt concept]
- British Thermal Unit [NCIt concept]
- Buffer [NCIt concept]
- Bulking Excipient [NCIt concept]
- CAS Number [NCIt concept]
- Can [NCIt concept]
- Can Dosing Unit [NCIt concept]
- Canister [NCIt concept]
- Capsule [NCIt concept]
- Carrier Excipient [NCIt concept]
- Carton [NCIt concept]
- Cartridge [NCIt concept]
- Cello Pack [NCIt concept]
- Centimeter [NCIt concept]
- Central File Number [NCIt concept]
- Chelating Agent [NCIt concept]
- Chemical [NCIt concept]
- Chemical Impurity [NCIt concept]
- Chemical Systematic Name [NCIt concept]
- Child Resistant Metal Container Closure [NCIt concept]
- Child Resistant Plastic Container Closure [NCIt concept]
- Clinical Batch [NCIt concept]
- Code of Federal Regulations Method [NCIt concept]
- Colony Forming Unit [NCIt concept]
- Color Excipient [NCIt concept]
- Combination Package [NCIt concept]
- Commercial Batch [NCIt concept]
- Company Identifier [NCIt concept]
- Company Standard [NCIt concept]
- Compendial Method [NCIt concept]
- Complex Environmental Condition [NCIt concept]
- Complexing Excipient [NCIt concept]
- Conformance [NCIt concept]
- Container [NCIt concept]
- Continuous Thread Metal Container Closure [NCIt concept]
- Continuous Thread Plastic Container Closure [NCIt concept]
- Crown Metal Container Closure [NCIt concept]
- Cryoprotective Agent [NCIt concept]
- Cubic Meter [NCIt concept]
- Cup [NCIt concept]
- Cycled-Simple Environmental Condition [NCIt concept]
- Data Universal Numbering System [NCIt concept]
- Day [NCIt concept]
- Degradant [NCIt concept]
- Degree Celsius [NCIt concept]
- Degree Fahrenheit [NCIt concept]
- Degree Unit of Plane Angle [NCIt concept]
- Delayed Testing [NCIt concept]
- Denaturant [NCIt concept]
- Development Batch [NCIt concept]
- Dewar [NCIt concept]
- Dialpack [NCIt concept]
- Disintegrant Excipient [NCIt concept]
- Dispensing Bottle [NCIt concept]
- Dispensing Vial [NCIt concept]
- Dispersing Excipient [NCIt concept]
- Does Not Conform [NCIt concept]
- Dose Pack [NCIt concept]
- Dropper Bottle [NCIt concept]
- Drug Component Mass [NCIt concept]
- Drug Kit [NCIt concept]
- Drug Package [NCIt concept]
- Drug Product Specification [NCIt concept]
- Drug Substance Specification [NCIt concept]
- Drug Vehicle [NCIt concept]
- Effervescent Excipient [NCIt concept]
- Ehrlich Unit [NCIt concept]
- Elemental Impurity [NCIt concept]
- Emollient Excipient [NCIt concept]
- Emulsifying Excipient [NCIt concept]
- Emulsion Stabilizing Excipient [NCIt concept]
- Enzyme Unit [NCIt concept]
- Equivalent [NCIt concept]
- European Pharmacopeia [NCIt concept]
- Facility FDA Establishment Identifier [NCIt concept]
- Filler Excipient [NCIt concept]
- Film Coating Excipient [NCIt concept]
- Flask [NCIt concept]
- Flexible Intermediate Bulk Container [NCIt concept]
- Flip-Top Dispensing Plastic Container Closure [NCIt concept]
- Foam Stabilizing Excipient [NCIt concept]
- Free Radical Scavenging Excipient [NCIt concept]
- Frozen Delayed Testing [NCIt concept]
- GSRS Preferred Term [NCIt concept]
- Gallon US [NCIt concept]
- Gas Cylinder [NCIt concept]
- Gelling Excipient [NCIt concept]
- Generic Investigational New Animal Drug File [NCIt concept]
- Generic Name [NCIt concept]
- Geopolitical Entities, Names, and Codes Terminology [NCIt concept]
- Glass Bottle [NCIt concept]
- Glass Syringe [NCIt concept]
- Glass Vial [NCIt concept]
- Glidant Excipient [NCIt concept]
- Gram [NCIt concept]
- Greater Than [NCIt concept]
- Greater Than or Equal To [NCIt concept]
- Hard Gelatin Capsule Shell [NCIt concept]
- Hard HPMC Capsule Shell [NCIt concept]
- Hard PVA Capsule Shell [NCIt concept]
- Hard Pullulan Capsule Shell [NCIt concept]
- Hard Starch Capsule Shell [NCIt concept]
- Hinged Dispensing Plastic Container Closure [NCIt concept]
- Horizontal [NCIt concept]
- Hour [NCIt concept]
- Human [NCIt concept]
- Humanitarian Device Exemption [NCIt concept]
- Humectant Excipient [NCIt concept]
- ISBT-128 Donation Identification Number [NCIt concept]
- IUPAC Name [NCIt concept]
- Immediate Testing [NCIt concept]
- Inch [NCIt concept]
- Inhaler [NCIt concept]
- Inhaler Refill [NCIt concept]
- Inorganic Impurity [NCIt concept]
- Insect [NCIt concept]
- International Chemical Identifier [NCIt concept]
- International Nonproprietary Name [NCIt concept]
- International Unit [NCIt concept]
- Inverted [NCIt concept]
- Investigational Device Exemption [NCIt concept]
- Investigational New Animal Drug File [NCIt concept]
- Investigational New Drug Application [NCIt concept]
- Japanese Pharmacopeia [NCIt concept]
- Jar [NCIt concept]
- Jug [NCIt concept]
- Kelvin [NCIt concept]
- Kilodalton [NCIt concept]
- Kilogram [NCIt concept]
- Kilogram-Force [NCIt concept]
- Leachable Material [NCIt concept]
- Less Than [NCIt concept]
- Less Than or Equal To [NCIt concept]
- Linear Foot Pound [NCIt concept]
- Lined Canister [NCIt concept]
- Linerless Plastic Container Closure [NCIt concept]
- Liter [NCIt concept]
- Lubricant Excipient [NCIt concept]
- Lug Metal Container Closure [NCIt concept]
- Lyophilization Excipient [NCIt concept]
- MDL Molfile Format [NCIt concept]
- MDL Structure-data File Format [NCIt concept]
- Macromolecular CIF [NCIt concept]
- Master File or Application Approved Indicator [NCIt concept]
- Material Identification [NCIt concept]
- Matrix Drug Release [NCIt concept]
- Matrix Forming Excipient [NCIt concept]
- Meter [NCIt concept]
- Microbial Contamination [NCIt concept]
- Microencapsulating Excipient [NCIt concept]
- Microgram [NCIt concept]
- Microliter [NCIt concept]
- Micromole [NCIt concept]
- Micron [NCIt concept]
- Microorganism [NCIt concept]
- Microsiemens [NCIt concept]
- Microwell Plate [NCIt concept]
- Milligram [NCIt concept]
- Milligram per Deciliter [NCIt concept]
- Milliliter [NCIt concept]
- Millimeter [NCIt concept]
- Millimole [NCIt concept]
- Milliosmole [NCIt concept]
- Millisiemens [NCIt concept]
- Minute [NCIt concept]
- Mole [NCIt concept]
- Month [NCIt concept]
- Multi Dose Vial [NCIt concept]
- Nanogram [NCIt concept]
- Nanometer [NCIt concept]
- Nanomole [NCIt concept]
- New Active Ingredient [NCIt concept]
- New Animal Drug Application [NCIt concept]
- New Drug Application [NCIt concept]
- Newton [NCIt concept]
- Not Applicable [NCIt concept]
- Not Approved [NCIt concept]
- Ointment Base [NCIt concept]
- Opacifying Excipient [NCIt concept]
- Ophthalmic Polymer [NCIt concept]
- Organoleptic Excipient [NCIt concept]
- Osmotic Excipient [NCIt concept]
- Osmotic Pump Drug Release [NCIt concept]
- Ounce [NCIt concept]
- PQ/CMC Batch Utilization Terminology [NCIt concept]
- PQ/CMC Capsule Shell Classification Terminology [NCIt concept]
- PQ/CMC Chemical Structure Data File Type Terminology [NCIt concept]
- PQ/CMC Closure Type Terminology [NCIt concept]
- PQ/CMC Conformance to Criteria Terminology [NCIt concept]
- PQ/CMC Container Orientation Terminology [NCIt concept]
- PQ/CMC Container Type Terminology [NCIt concept]
- PQ/CMC Drug Product Component Function Category Terminology [NCIt concept]
- PQ/CMC Excipient Function Terminology [NCIt concept]
- PQ/CMC Expiration Date Classification Terminology [NCIt concept]
- PQ/CMC Impurity Classification Terminology [NCIt concept]
- PQ/CMC Interpretation Code (numeric) Terminology [NCIt concept]
- PQ/CMC Interval Description Code Terminology [NCIt concept]
- PQ/CMC Manufacturing Site Unique Identifier Type Terminology [NCIt concept]
- PQ/CMC Quality Benchmark Terminology [NCIt concept]
- PQ/CMC Release Mechanism Terminology [NCIt concept]
- PQ/CMC Retest Date Classification Terminology [NCIt concept]
- PQ/CMC Source Type Terminology [NCIt concept]
- PQ/CMC Specification Status Terminology [NCIt concept]
- PQ/CMC Specification Type Terminology [NCIt concept]
- PQ/CMC Sponsor Identifier Type Terminology [NCIt concept]
- PQ/CMC Stability Study Reason Terminology [NCIt concept]
- PQ/CMC Storage Conditions Terminology [NCIt concept]
- PQ/CMC Strength Operator Terminology [NCIt concept]
- PQ/CMC Strength Type Terminology [NCIt concept]
- PQ/CMC Study Type Terminology [NCIt concept]
- PQ/CMC Substance Name Type Terminology [NCIt concept]
- PQ/CMC Test Category Terminology [NCIt concept]
- PQ/CMC Test Method Origin Terminology [NCIt concept]
- PQ/CMC Test Usage Terminology [NCIt concept]
- PQ/CMC Testing Site Unique Identifier Type Terminology [NCIt concept]
- PQ/CMC Units of Measure Terminology [NCIt concept]
- Package Type Not Stated [NCIt concept]
- Packaging Case [NCIt concept]
- Packaging Drum [NCIt concept]
- Packaging Tank [NCIt concept]
- Packaging Tube [NCIt concept]
- Packet [NCIt concept]
- Pail [NCIt concept]
- Parenteral Vial [NCIt concept]
- Part Per Billion [NCIt concept]
- Part Per Million [NCIt concept]
- Part Per Trillion [NCIt concept]
- Part per Thousand [NCIt concept]
- Particle Total Count [NCIt concept]
- Patch [NCIt concept]
- Patent Delivery System Vial [NCIt concept]
- Percent Mass per Mass [NCIt concept]
- Percent Mass per Volume [NCIt concept]
- Percent Unit [NCIt concept]
- Percent Volume per Volume [NCIt concept]
- Petri Dish [NCIt concept]
- Pharmaceutical Excipient [NCIt concept]
- Pharmacy Bulk Vial [NCIt concept]
- Photostability Drug Study [NCIt concept]
- Picogram [NCIt concept]
- Picomole [NCIt concept]
- Piggyback Vial [NCIt concept]
- Pint [NCIt concept]
- Plant [NCIt concept]
- Plastic Bottle [NCIt concept]
- Plastic Syringe [NCIt concept]
- Plastic Vial [NCIt concept]
- Plasticizer [NCIt concept]
- Polishing Excipient [NCIt concept]
- Pouch [NCIt concept]
- Pound [NCIt concept]
- Pound per Square Inch [NCIt concept]
- Pre-market Approval Application [NCIt concept]
- Premarket Device Notification [NCIt concept]
- Preservative Excipient [NCIt concept]
- Press-On Composite Container Closure [NCIt concept]
- Press-On/Twist-Off Metal Container Closure [NCIt concept]
- Printing Ink Excipient [NCIt concept]
- Product Description/Appearance [NCIt concept]
- Product Related Impurity [NCIt concept]
- Propellant [NCIt concept]
- Proposed Substance Date Change [NCIt concept]
- Proprietary Method [NCIt concept]
- Proprietary Name [NCIt concept]
- Proprietary Storage Condition [NCIt concept]
- Protein Data Bank [NCIt concept]
- Pump Bottle [NCIt concept]
- Pump Dispensing Plastic Container Closure [NCIt concept]
- Push-Pull Dispensing Plastic Container Closure [NCIt concept]
- Quart Dry US [NCIt concept]
- Radian [NCIt concept]
- Raw Materials/Excipients/Intermediates/Reagents Specification [NCIt concept]
- Reducing Excipient [NCIt concept]
- Refrigerated Delayed Testing [NCIt concept]
- Release Determination [NCIt concept]
- Release Modifying Excipient [NCIt concept]
- Reported in a CBE or AR [NCIt concept]
- Reservoir Drug Release [NCIt concept]
- Residual Solvent [NCIt concept]
- Roll On Metal Container Closure [NCIt concept]
- SPL Drug Route of Administration Terminology [NCIt concept]
- SPL Pharmaceutical Dosage Form Terminology [NCIt concept]
- Second [NCIt concept]
- Simplified Molecular Input Line Entry Specification [NCIt concept]
- Single Dose Vial [NCIt concept]
- Single Use Vial [NCIt concept]
- Snap-On Cap Plastic Container Closure [NCIt concept]
- Snip-Tip Dispensing Plastic Container Closure [NCIt concept]
- Soft Gelatin Capsule Shell [NCIt concept]
- Solubilizing Excipient [NCIt concept]
- Solvent [NCIt concept]
- Spray Bottle [NCIt concept]
- Square Meter [NCIt concept]
- Stability Determination [NCIt concept]
- Stability Study Batch [NCIt concept]
- Stabilizing Excipient [NCIt concept]
- Standard Environmental Condition [NCIt concept]
- Stopper Container Closure [NCIt concept]
- Supersack [NCIt concept]
- Suppository Base [NCIt concept]
- Surfactant Excipient [NCIt concept]
- Suspending Excipient [NCIt concept]
- Syringe [NCIt concept]
- Tablet Dosing Unit [NCIt concept]
- Tabminder [NCIt concept]
- Tamper Evident Composite Container Closure [NCIt concept]
- Tamper Evident Metal Container Closure [NCIt concept]
- Tamper Evident Plastic Container Closure [NCIt concept]
- Temperature -20 (+/-) 5 Degrees C [NCIt concept]
- Temperature 25 (+/-) 2 Degrees C and Relative Humidity 40% (+/-) 5% [NCIt concept]
- Temperature 25 (+/-) 2 Degrees C and Relative Humidity 60% (+/-) 5% [NCIt concept]
- Temperature 30 (+/-) 2 Degrees C and Relative Humidity 35% (+/-) 5% [NCIt concept]
- Temperature 30 (+/-) 2 Degrees C and Relative Humidity 65% (+/-) 5% [NCIt concept]
- Temperature 30 (+/-) 2 Degrees C and Relative Humidity 75% (+/-) 5% [NCIt concept]
- Temperature 40 (+/-) 2 Degrees C and Relative Humidity 75% (+/-) 5% [NCIt concept]
- Temperature 40 (+/-) 2 Degrees C and Relative Humidity Not More Than 25% [NCIt concept]
- Temperature 5 (+/-) 3 Degrees C [NCIt concept]
- Tentative Approval [NCIt concept]
- Tie Container Closure [NCIt concept]
- Toggle-Swing Dispensing Plastic Container Closure [NCIt concept]
- Tonicity Excipient [NCIt concept]
- Transdermal Delivery Excipient [NCIt concept]
- Transfer Ligand Excipient [NCIt concept]
- Tray [NCIt concept]
- Trigger Spray Dispensing Plastic Container Closure [NCIt concept]
- Twist Open/Close Dispensing Plastic Container Closure [NCIt concept]
- USP-NF Established Name [NCIt concept]
- Unified Atomic Mass Unit [NCIt concept]
- Unit Dose Bottle [NCIt concept]
- Unit Dose Box [NCIt concept]
- Unit Dose Cup [NCIt concept]
- Unit per Square Meter per Day [NCIt concept]
- United States Adopted Name [NCIt concept]
- United States Pharmacopeia-National Formulary [NCIt concept]
- Unknown [NCIt concept]
- Upright [NCIt concept]
- Vacuum Sealed Composite Container Closure [NCIt concept]
- Vacuum Sealed Metal Container Closure [NCIt concept]
- Vacuum Sealed Plastic Container Closure [NCIt concept]
- Validation Batch [NCIt concept]
- Valve-down [NCIt concept]
- Valve-up [NCIt concept]
- Valved Dispensing Plastic Container Closure [NCIt concept]
- Vial Dosing Unit [NCIt concept]
- Viscosity Modifying Excipient [NCIt concept]
- Water Repelling Excipient [NCIt concept]
- Week [NCIt concept]
- Wetting Excipient [NCIt concept]
- Year [NCIt concept]
- pH Modifying Excipient [NCIt concept]

Keyword's position in hierarchy(ies) :

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