FUZKK Pharma Utilities Portal

A catalogue of pharmacopoeial utilities for Quality Control: calculations, CSV input checks, JSON outputs and software validation preparation.

152
Packages
1975
Utilities
209
Categories
617
Tags

Summary

CSV / LIMS / ELN / MES

The portal consolidates utility packages for pharmacopoeial quality control, radiopharma, medical gases, liquids, API monographs and specialist product groups.

Instrument / LIMS / ELN / MES → input.csv → FUZKK Utility → output.json → QA review / batch record

Audit readiness

Audit readiness (IQ/OQ). Each utility is supplied with URS and FS templates. This significantly accelerates software validation for FDA/EMA/Roszdravnadzor inspections.

Packages

All

RPH: combined radiopharmaceutical QC package

107

RPH combines PetRad, PetRad2 and PetRad3 into one umbrella package for PET/SPECT, therapeutic radionuclides, generators, labelled compounds, decay calculations, sterility, endotoxins and radiochemical/radionuclidic purity.

RPH PetRad PetRad2 PetRad3
Open

Rph Hyperpolarized Xenon Lifecycle QC Suite

29

29 utilities for the hyperpolarized xenon lifecycle: isotope composition and gas purity, SEOP and polarization, T1/storage/transport, safe blending and delivery, MRI/SPECT QC, dosimetry, scavenging, recovery and recycling.

RPH Hyperpolarized Xenon Xe-129 Xe-133
Open

RPH Tc-99m Renal Radiopharmaceutical and Imaging QC Suite

16

16 utilities covering the Tc-99m renal workflow: generator eluate and Mo-99 breakthrough, Sn(II), labeling stoichiometry and pH, radiochemical purity and stability of MAG3, DTPA, DMSA(III) and glucoheptonate, gamma-camera uniformity, renal uptake and plasma clearance, bladder voiding efficiency, patient dosimetry and decay-in-storage waste management.

RPH Tc-99m renal imaging renal scintigraphy
Open

Radiopharmaceutical Diagnostics and Therapy QC Suite

36

36 utilities for clinically oriented radiopharmaceutical and workflow quality control: PET/SPECT tracers, the Tc-99m renal workflow, PRRT, PSMA therapy, targeted alpha therapy, radioembolization, bone-pain palliation, immuno-PET and generator-based radionuclide control.

radiopharmaceuticals nuclear-medicine pet spect
Open

PET Scanner State QC Suite

14

14 utilities for PET/PET-CT scanner state control: Ge-68/Ga-68 source activity, blank sinogram, detector efficiency, normalization acquisition and factor distribution, normalization-file assignment, trending, energy window, TOF, attenuation-correction map, PET/CT cross-calibration and the daily operational decision.

RPH PET PET/CT scanner state
Open

LabEx QC Suite

60

LabEx package for laboratory QC methods: chromatography, spectroscopy, microbiology, sterility, endotoxins, particles, dissolution, water, cleanrooms and sample preparation.

LabEx laboratory QC instrumental methods microbiology
Open

Categories

AAS / elemental impurities API QC API impurities / assay BP monographs Biologics / complex molecules Biologics QC Capillary electrophoresis Capillary electrophoresis / CE QC Complex molecules Content uniformity Contraceptives Core QC utility packages Country essential medicines Dermal fillers Dissolution Dissolution and comparative profiles Dosage unit uniformity EAEU pharmacopoeia Elemental impurities Excipient QC Excipients Excipients / preservatives Excipients QC Fluorat / fluorimetry Fluorescence Fluorescence / Fluorat methods Fluorimetry General QC General pharmaceutical QC Global API Global API expansion Herbal pharmacopoeia Huvac Huvac — Human Vaccine QC Utilities IR identification Impurities Impurities / ICH M7 Impurities / assay Infrared identification Instrumental analysis Laboratory QC / instrumental methods Liquid Biopsy LiquidBiopsy Lumex Medical gases Mercury analysis Mercury analysis / elemental impurities Method validation Method validation / documentation Molecular diagnostics QC packages NIR / PAT NIR / PAT and spectroscopic QC NIR / PAT checks PET/Radiotherapy expansion Packaging materials Packaging polymer identification PetRad3 Pharmaceutical QC Pharmacopoeial methods Polymer identification Radiation physics Radiopharmaceutical QC Radiopharmaceuticals Risk assessment Stability Stability and shelf-life modelling Statistical QC / outlier detection Statistics Sterile liquids System suitability System suitability / chromatography QC Therapeutic and product-area packages Vaccine and biologics QC packages Validation Vet Vet — Veterinary QC Utilities Vitamins / nutritional QC Vitamins and excipients Vitamins and minerals Therapeutic / Biopharma Therapeutic / Dental / Medical devices adjacency Therapeutic / Infectious diseases Therapeutic / Immunology / Biologics Risk / Toxicology / Impurities Therapeutic / Addiction medicine / Controlled substances Ayurveda / Herbal QC Ayurveda Herbal/BHP Biopharmaceuticals / Immunology Biopharmaceuticals Immunology mAb Traditional Chinese Medicine / Herbal QC TCM Botanical QC Herbal / Ayurveda Herbal / Traditional Chinese Medicine Infectious diseases / HIV FDC QC FDC / Combination products Missing API backlog Respiratory / inhaler FDC QC Plasma-derived product QC Diabetes / endocrinology combination QC Infectious diseases / malaria FDC QC Cardiology / fixed-dose combination QC Gastroenterology / FDC QC Biopharma / oncology advanced modality QC Analgesic / OTC FDC QC Vaccine combination product QC Infectious diseases / TB QC Radiopharma / commercial radioligand QC Ophthalmology / glaucoma FDC QC Advanced Pharma / CellGeneTherapyViralVector Suite pharma FUZKK backlog 2026 Advanced Pharma / InhaledProducts Suite Advanced Pharma / FermentationAntibioticIntermediates Suite Advanced Pharma / OphthalmicIntravitreal Suite Advanced Pharma / PlasmaDerivedProducts Suite Advanced Pharma / HerbalTCMAyurvedaFingerprinting Suite Advanced Pharma / RadioligandTheranosticsExpansion Suite Advanced Pharma / ADCConjugatedBiologics Suite Advanced Pharma / PeptidesGLP1Obesity Suite Advanced Pharma / MRNALNPQuality Suite Medical Devices / FDAMedicalDeviceCompliance Suite medical-device Medical Devices / CybersecurityForMedicalDevices Suite Medical Devices / UsabilityEngineering Suite Medical Devices / Biocompatibility Suite Medical Devices / SterileMedicalDevices Suite Medical Devices / ElectricalSafetyEMC Suite Medical Devices / UDILabeling Suite Medical Devices / MedicalDeviceRiskManagement Suite Medical Devices / MedicalDeviceQMS Suite Medical Devices / MedicalDeviceSoftware Suite FUZKK utility packages Hyperpolarized xenon equipment, safety and lifecycle QC Radiopharmaceuticals / hyperpolarized gas MRI RPH Xenon lifecycle Hyperpolarized xenon instrumental, dosimetry and imaging QC Hyperpolarized xenon / medical gas product QC Radiopharmaceuticals / Hyperpolarized gas MRI / Lifecycle QC Renal nuclear medicine clinical calculation support Radiopharmaceuticals / Tc-99m renal imaging RPH Tc-99m Renal Radiopharmaceutical and Imaging QC Suite Gamma camera and renal imaging system QC Tc-99m kit formulation and reducing-agent control Renal uptake and quantitative scintigraphy support Renal plasma clearance calculation support Tc-99m kit reagent stability QC Tc-99m kit reducing-agent concentration QC Tc-99m renal radiopharmaceutical release QC Tc-99m renal radiopharmaceutical stability QC Tc-99m generator eluate and radionuclidic QC Tc-99m kit labeling-process optimization Renal nuclear medicine dosimetry support Tc-99m radiation-safety and waste lifecycle control Radiopharmaceuticals / Tc-99m renal imaging / Lifecycle QC PET source activity and decay control PET scanner QC PET Scanner State QC Suite PET detector state and sinogram QC PET scanner daily state decision PET detector efficiency QC PET normalization factor QC PET normalization acquisition QC PET normalization statistical QC PET normalization configuration control PET detector normalization trending PET QC source lifecycle control PET/CT attenuation correction QC PET quantitative cross-calibration QC PET energy calibration QC PET TOF timing QC PET scanner QC / detector state / normalization Gastroenterology / API QC Gastroenterology Chiral API QC Radiopharmaceuticals / Radionuclide therapy Nuclear medicine Radionuclide therapy Radiopharmaceuticals / Diagnostic radiopharmaceuticals Diagnostic radiopharmaceuticals Radiopharmaceuticals / Clinical nuclear medicine Radiopharmaceuticals / RPH Tc-99m MAA Lung Perfusion and Radioembolization Planning QC Suite RPH Tc-99m MAA Lung Perfusion and Radioembolization Planning QC Suite Radiopharmaceuticals / RPH Tc-99m Hepatobiliary and HIDA QC Suite RPH Tc-99m Hepatobiliary and HIDA QC Suite Radiopharmaceuticals / RPH Labelled Leukocyte Preparation and Release QC Suite RPH Labelled Leukocyte Preparation and Release QC Suite Radiopharmaceuticals / RPH Tc-99m Pertechnetate Functional Imaging QC Suite RPH Tc-99m Pertechnetate Functional Imaging QC Suite Radiopharmaceuticals / RPH Cr-51 Labelled Red Blood Cells QC Suite RPH Cr-51 Labelled Red Blood Cells QC Suite Radiopharmaceuticals / RPH Gastrointestinal Nuclear Medicine QC Suite RPH Gastrointestinal Nuclear Medicine QC Suite Radiopharmaceuticals / RPH Pulmonary Ventilation and Perfusion QC Suite RPH Pulmonary Ventilation and Perfusion QC Suite Radiopharmaceuticals / RPH Lymphoscintigraphy and Sentinel Node QC Suite RPH Lymphoscintigraphy and Sentinel Node QC Suite Radiopharmaceuticals / RPH Labelled Blood Cells QC Suite RPH Labelled Blood Cells QC Suite Radiopharmaceuticals / RPH Infection and Inflammation Imaging QC Suite RPH Infection and Inflammation Imaging QC Suite Radiopharmaceuticals / Nuclear medicine workflow Radiopharmaceuticals / Navigation / UseCase Radiopharmaceuticals / Navigation / Isotope Radiopharmaceuticals / Navigation / OrganSystem Radiopharmaceuticals / Navigation / Workflow