Pharmaceutical Quality (Industry)
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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:

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

CodeDisplay
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