Pharmaceutical Quality (Industry)
1.0.0 - STU1

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

## CodeSystem: Example Local Codes - Drug

Official URL: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example | Version: 1.0.0
Active as of 2024-05-08 | Computable Name: CsLocalCodesDrugPQ
Other Identifiers: OID:2.16.840.1.113883.4.642.40.41.16.6

This example code system contains temporary example codes used in pharmaceutical quality industry.

This Code system is referenced in the content logical definition of the following value sets:

- MedicinalProductCharacteristicType
- VsProcessValidationProcedurePQ
- VsTestMethodPQ

This case-sensitive code system `http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example` defines the following codes:

Code | Display
ionic-strength | Ionic Strength
physicochemical | Physicochemical properties
SE-UHPLCHMW-15 | SE-UHPLC HMW - 15
SE-UHPLCHMW-25 | SE-UHPLC HMW - 25
SE-UHPLCMainPeak-15 | SE-UHPLC Main Peak - 15
SE-UHPLCMainPeak-25 | SE-UHPLC Main Peak - 25
SIZE | Particle Size
SOL | Residual solvents
SOLV | Solvent
SSE | Statistically significant effects
TEMP | Temperature
UCL | Upper one-sided 95% confidence limit of Max Difference
uniformity-dosage | uniformity of dosage units (by weight)
WWWH | Water Content Homogeneity
SAMP | Number of Samples
DGP | Degradation Products
DGP-s | Drug Substance Related Organic impurities
IMP | Impurity
Impurities | Impurities
WWW | Water Content
Microbiological Quality | Microbiological Quality
ASSAY | Assay
CEX-HPLCAcidicPeak | CEX-HPLC Acidic Peak
CEX-HPLCMainPeak | CEX-HPLC Main Peak
PART | Particle size distribution
ASSH | Assay Content Homogeneity
DESC | Description
Dissolution | Dissolution
Dissolution Quantity | Dissolution Quantity
ELE | Elemental impurities
enantiomeric-purity | Enantiomeric purity
IDT | Identification
MUT | Mutagenic impurities
NMR | NMR
NMR-C | NMR-C
NMR-H | NMR-H
CEX-HPLCAcidicPeak-15 | CEX-HPLC Acidic Peak - 15
CEX-HPLCAcidicPeak-25 | CEX-HPLC Acidic Peak - 25
CEX-HPLCMainPeak-15 | CEX-HPLC Main Peak - 15
CEX-HPLCMainPeak-25 | CEX-HPLC Main Peak - 25
Homogeneity | Homogeneity demonstrated
LCL | Lower one-sided 95% confidence limit of Max Difference
LOC | Number of Locations
PARTS | Particle size
POS | Structure Position
particle-size-distribution | Particle size distribution
Lyophilization Water Homogeneity | Lyophilization Water Homogeneity
Lyophilization Assay Homogeneity | Lyophilization Assay Homogeneity
Particle Size RSD | Particle Size RSD
Obscuration | Obscuration
Refractive index | Refractive index
ElementalAnalysisCarbon | Elemental Analysis Carbon (%)
IonAnalysisCarbonMass | Ion Analysis Carbon - Mass
IonAnalysisCarbonMassAccuracy | Ion Analysis Carbon - Mass Accuracy
IonAnalysisCarbon | Ion Analysis Carbon (%)
ElementalAnalysisHydrogen | Elemental Analysis Hydrogen (%)
IonAnalysisHydrogenMass | Ion Analysis Hydrogen - Mass
IonAnalysisHydrogenMassAccuracy | Ion Analysis Hydrogen - Mass Accuracy
IonAnalysisHydrogen | Ion Analysis Hydrogen (%)
ElementalAnalysisNitrogen | Elemental Analysis Nitrogen (%)
IonAnalysisNitrogen | Ion Analysis Nitrogen (%)
IonAnalysisNitrogenMass | Ion Analysis Nitrogen - Mass
IonAnalysisNitrogenMassAccuracy | Ion Analysis Nitrogen - Mass Accuracy
ElementalAnalysisFlourine | Elemental Analysis Flourine (%)
IonAnalysisFlourine | Ion Analysis Flourine (%)
IonAnalysisFlourineMass | Ion Analysis Flourine - Mass
IonAnalysisFlourineMassAccuracy | Ion Analysis Flourine - Mass Accuracy
Chemical Structure | Chemical Structure
Diffractogram | Diffractogram
MolecularStructure | Molecular Structure
Absorption | Absorption
X-Ray Powder Diffractogram | X-Ray Powder Diffractogram
pH (post-dilution bulk solution) | pH (post-dilution bulk solution)
Appearance (Product Container, visual) | Appearance (Product Container, visual)
Appearance (Lyophilized, Visual) | Appearance (Lyophilized, Visual)
Appearance (Reconstituted, Visual) | Appearance (Reconstituted, Visual)
Appearance | Appearance
pH (reconstituted) | pH (reconstituted)
TAMC | TAMC
Fill Weight Average | Fill Weight Average
Fill Weight Target (g) | Fill Weight Target (g)
Actual Avg. Weight from Target | Actual Avg. Weight from Target
Hold Time (filtration To filling) | Hold Time (filtration To filling)
Hold Time (start filling to end filling) | Hold Time (start filling to end filling)
Filter Integrity Test | Filter Integrity Test
Lyophilizer Number | Lyophilizer Number
pH (adjustment of pre-clarification bulk solution) | pH (adjustment of pre-clarification bulk solution)
Assay (pre-clarification filtration) (mg/mL) | Assay (pre-clarification filtration) (mg/mL)
Assay (Post dilution bulk solution) (mg/mL) | Assay (Post dilution bulk solution) (mg/mL)
Test Date | Test Date
Identification (NMR) | Identification (NMR)
Identification (FT-IR) | Identification (FT-IR)
VisualInspection | VisualInspection
InfraredSpectroscopy | InfraredSpectroscopy
SupplierCertificateofAnalysis | SupplierCertificateofAnalysis
Elemental | Elemental
Uniformity of Dosage Units, Weight Variation | Uniformity of Dosage Units, Weight Variation
Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV) | Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV)
Yield (%) | Yield (%)
ResidualWaterContent | Residual Water Content (w/w%)
Reaction conversion: Residual Starting Material 1 by HPLC | Reaction conversion: Residual Starting Material 1 by HPLC
Bacterial Endotoxins (EU/mL) | Bacterial Endotoxins (EU/mL)
Bioburden - Beginning | Bioburden - Beginning
Bioburden - End | Bioburden - End
Bioburden (CFU/ 100 mL) | Bioburden (CFU/ 100 mL)
Buffer vessel mixing speed (rpm) | Buffer vessel mixing speed (rpm)
Buffer vessel mixing time (min) | Buffer vessel mixing time (min)
CONC | Conclusion
Conductivity (μS/cm) | Conductivity (μS/cm)
Fill Weight | Fill Weight
Fill Weight - Maximum | Fill Weight - Maximum
Fill Weight - Mean | Fill Weight - Mean
Fill Weight - Minimum | Fill Weight - Minimum
FiltrationPressure (psig) | FiltrationPressure (psig)
Formulation vessel mixing speed (rpm) | Formulation vessel mixing speed (rpm)
Formulation vessel mixing time (min) | Formulation vessel mixing time (min)
Growth Promotion - Beginning | Growth Promotion - Beginning
Growth Promotion - End | Growth Promotion - End
GrowthPromotion | Growth Promotion
Hold Time | Hold Time
LyophilizationHomogeneneity | Lyophilization Homogeneneity
Media Challenge Hold Times | Media Challenge Hold Times
MediaChallengeRun | Media Challenge Run
Osmolality | Osmolality
OVERALLSAMP | Number of Samples
particle-size | Particle Size
pH | pH
Polysorbate 80 (% w/v) | Polysorbate 80 (% w/v)
Polysorbate 80 concentration - Beginning - Max | Polysorbate 80 concentration - Beginning - Max
Polysorbate 80 concentration - Beginning - Min | Polysorbate 80 concentration - Beginning - Min
Polysorbate 80 concentration - End - Max | Polysorbate 80 concentration - End - Max
Polysorbate 80 concentration - End - Min | Polysorbate 80 concentration - End - Min
Polysorbate 80 concentration - Middle - Max | Polysorbate 80 concentration - Middle - Max
Polysorbate 80 concentration - Middle - Min | Polysorbate 80 concentration - Middle - Min
Polysorbate 80 concentration (% w/v) | Polysorbate 80 concentration (% w/v)
Post-filtration Filter Integrity (psig) | Post-filtration Filter Integrity (psig)
Pre-filtration Bioburden (CFU/ 100 mL) | Pre-filtration Bioburden (CFU/ 100 mL)
Protein Concentration (mg/mL) | Protein Concentration (mg/mL)
Protein Concentration - Beginning - End - Higher | Protein Concentration - Beginning - End - Higher
Protein Concentration - Beginning - End - Lower | Protein Concentration - Beginning - End - Lower
Protein Concentration - Beginning - End - Mean | Protein Concentration - Beginning - End - Mean
Protein Concentration - Beginning - Max | Protein Concentration - Beginning - Max
Protein Concentration - Beginning - Middle - Higher | Protein Concentration - Beginning - Middle - Higher
Protein Concentration - Beginning - Middle - Lower | Protein Concentration - Beginning - Middle - Lower
Protein Concentration - Beginning - Middle - Mean | Protein Concentration - Beginning - Middle - Mean
Protein Concentration - Beginning - Min | Protein Concentration - Beginning - Min
Protein Concentration - Conclusion | Protein Concentration - Conclusion
Protein Concentration - End - Max | Protein Concentration - End - Max
Protein Concentration - End - Min | Protein Concentration - End - Min
Protein Concentration - Middle - End - Higher | Protein Concentration - Middle - End - Higher
Protein Concentration - Middle - End - Lower | Protein Concentration - Middle - End - Lower
Protein Concentration - Middle - End - Mean | Protein Concentration - Middle - End - Mean
Protein Concentration - Middle - Max | Protein Concentration - Middle - Max
Protein Concentration - Middle - Min | Protein Concentration - Middle - Min
Protein Concentration Statistics | Protein Concentration Statistics
Residual Moisture - Max | Residual Moisture - Max
Residual Moisture - Min | Residual Moisture - Min
Residual Moisture | Residual Moisture
SE-UHPLC Main Peak - Beginning | SE-UHPLC Main Peak - Beginning
SE-UHPLC HMW - Conclusion | SE-UHPLC HMW - Conclusion
SE-UHPLC Main Peak - Conclusion | SE-UHPLC Main Peak - Conclusion
SE-UHPLC Main Peak - End | SE-UHPLC Main Peak - End
SE-UHPLCHMW - Beginning | SE-UHPLC HMW - Beginning
SE-UHPLCHMW - End | SE-UHPLC HMW - End
SE-UHPLCHMWPeak - Conclusion | SE-UHPLC HMW Peak - Conclusion
SE-UHPLCHMW | SE-UHPLC HMW
SE-UHPLCMainPeak - Conclusion | SE-UHPLC Main Peak - Conclusion
SE-UHPLCMainPeak | SE-UHPLC Main Peak
test-success | Test Success
Thaw Time | Thaw Time
Thawing Temp | Thawing Temp
WaterContent | Water content
AssignedPurity | Assigned Purity
1d2344 | Tape
200000003208 | Plastic
112344ss | PVC