ArtesunateAmodiaquineQualityChecker
Artesunate/Amodiaquine Quality Checker
Antimalarial CSV→JSON FDC Malaria MissingAPI P2 QC URS & FS
Open selectionArtesunate/Amodiaquine Quality Checker — Antimalarial Product Quality Control
ℹ️ Utility checks critical parameters of artesunate and amodiaquine combination:
• Artesunate Assay: 90.0–110.0%
• Amodiaquine Assay: 90.0–110.0%
• Dihydroartemisinin (Impurity): ≤2.0%
• Desethylamodiaquine (Impurity): ≤1.0%
• Total Impurities: ≤3.0%
• Dissolution of each component: ≥85% (Q)
• Moisture Content: ≤5.0%
• Heavy Metals: ≤20 ppm
⚠️ CRITICAL: Artesunate is highly unstable in humid environments and rapidly hydrolyzes to dihydroartemisinin.
Increased moisture (>5%) is unacceptable and leads to loss of efficacy.
Usage:
ArtesunateAmodiaquineQualityChecker.exe → demo mode
ArtesunateAmodiaquineQualityChecker.exe input.csv output.json → evaluate data
Input format:
BatchNumber,ArtesunateAssayPercent,AmodiaquineAssayPercent,DihydroartemisininPercent,DesethylamodiaquinePercent,TotalImpuritiesPercent,DissolutionArtesunatePercent,DissolutionAmodiaquinePercent,MoistureContentPercent,HeavyMetalsPPM
Example:
ART-AMQ-2026-001,100.5,99.2,1.2,0.4,2.1,91.0,93.5,3.8,6.0
— WHY IS THIS NEEDED?
Artesunate and amodiaquine combination is one of the WHO-recommended ACT regimens for malaria:
• Artesunate — artemisinin derivative, fast-acting schizontocide
• Amodiaquine — long-acting schizontocide, prevents recrudescence
• Artesunate is chemically unstable, especially in the presence of moisture
• Hydrolysis of artesunate leads to formation of dihydroartemisinin (DHA)
⚠️ CRITICAL:
• Assay 90.0–110.0% for each component — ensures parasite destruction
• Dihydroartemisinin ≤2.0% — main degradation product of artesunate
• Desethylamodiaquine ≤1.0% — degradation/metabolite product of amodiaquine
• Total Impurities ≤3.0% — overall purity indicator
• Dissolution ≥85% for each component — ensures bioavailability
• Moisture Content ≤5.0% — CRITICAL! Artesunate degrades at high humidity
• Heavy Metals ≤20 ppm — drug safety
Key features:
• Specific control of dihydroartemisinin as a marker of artesunate hydrolysis
• Control of desethylamodiaquine as a marker of amodiaquine stability
• Strict moisture limit to prevent active substance decomposition
• Compliance with WHO guidelines for antimalarial product quality
Critical parameters:
• Artesunate Assay: 90.0–110.0%
• Amodiaquine Assay: 90.0–110.0%
• Dihydroartemisinin Impurity: ≤2.0%
• Desethylamodiaquine Impurity: ≤1.0%
• Total Impurities: ≤3.0%
• Dissolution (each): ≥85% (Q)
• Moisture Content: ≤5.0%
• Heavy Metals: ≤20 ppm
💡 Usage tips:
1. Artesunate analyzed by HPLC with UV detection or ELSD
2. Dihydroartemisinin controlled by specific HPLC method
3. Moisture determined by Karl Fischer method (most accurate for low values)
4. Store in airtight packaging with desiccant
5. Perform analysis as soon as possible after opening packaging
6. If high DHA levels detected, check storage and transportation conditions
⚠️ Note: Artesunate is the hemisuccinate of artemisinin and is easily subject to hydrolysis even at room temperature in humid air. This makes moisture control the most important stability parameter for this combination. Decomposition of artesunate reduces therapy efficacy and may contribute to the development of Plasmodium resistance.
ℹ️ Utility checks critical parameters of artesunate and amodiaquine combination:
• Artesunate Assay: 90.0–110.0%
• Amodiaquine Assay: 90.0–110.0%
• Dihydroartemisinin (Impurity): ≤2.0%
• Desethylamodiaquine (Impurity): ≤1.0%
• Total Impurities: ≤3.0%
• Dissolution of each component: ≥85% (Q)
• Moisture Content: ≤5.0%
• Heavy Metals: ≤20 ppm
⚠️ CRITICAL: Artesunate is highly unstable in humid environments and rapidly hydrolyzes to dihydroartemisinin.
Increased moisture (>5%) is unacceptable and leads to loss of efficacy.
Usage:
ArtesunateAmodiaquineQualityChecker.exe → demo mode
ArtesunateAmodiaquineQualityChecker.exe input.csv output.json → evaluate data
Input format:
BatchNumber,ArtesunateAssayPercent,AmodiaquineAssayPercent,DihydroartemisininPercent,DesethylamodiaquinePercent,TotalImpuritiesPercent,DissolutionArtesunatePercent,DissolutionAmodiaquinePercent,MoistureContentPercent,HeavyMetalsPPM
Example:
ART-AMQ-2026-001,100.5,99.2,1.2,0.4,2.1,91.0,93.5,3.8,6.0
— WHY IS THIS NEEDED?
Artesunate and amodiaquine combination is one of the WHO-recommended ACT regimens for malaria:
• Artesunate — artemisinin derivative, fast-acting schizontocide
• Amodiaquine — long-acting schizontocide, prevents recrudescence
• Artesunate is chemically unstable, especially in the presence of moisture
• Hydrolysis of artesunate leads to formation of dihydroartemisinin (DHA)
⚠️ CRITICAL:
• Assay 90.0–110.0% for each component — ensures parasite destruction
• Dihydroartemisinin ≤2.0% — main degradation product of artesunate
• Desethylamodiaquine ≤1.0% — degradation/metabolite product of amodiaquine
• Total Impurities ≤3.0% — overall purity indicator
• Dissolution ≥85% for each component — ensures bioavailability
• Moisture Content ≤5.0% — CRITICAL! Artesunate degrades at high humidity
• Heavy Metals ≤20 ppm — drug safety
Key features:
• Specific control of dihydroartemisinin as a marker of artesunate hydrolysis
• Control of desethylamodiaquine as a marker of amodiaquine stability
• Strict moisture limit to prevent active substance decomposition
• Compliance with WHO guidelines for antimalarial product quality
Critical parameters:
• Artesunate Assay: 90.0–110.0%
• Amodiaquine Assay: 90.0–110.0%
• Dihydroartemisinin Impurity: ≤2.0%
• Desethylamodiaquine Impurity: ≤1.0%
• Total Impurities: ≤3.0%
• Dissolution (each): ≥85% (Q)
• Moisture Content: ≤5.0%
• Heavy Metals: ≤20 ppm
💡 Usage tips:
1. Artesunate analyzed by HPLC with UV detection or ELSD
2. Dihydroartemisinin controlled by specific HPLC method
3. Moisture determined by Karl Fischer method (most accurate for low values)
4. Store in airtight packaging with desiccant
5. Perform analysis as soon as possible after opening packaging
6. If high DHA levels detected, check storage and transportation conditions
⚠️ Note: Artesunate is the hemisuccinate of artemisinin and is easily subject to hydrolysis even at room temperature in humid air. This makes moisture control the most important stability parameter for this combination. Decomposition of artesunate reduces therapy efficacy and may contribute to the development of Plasmodium resistance.
input.csv
BatchNumber,ArtesunateAssayPercent,AmodiaquineAssayPercent,DihydroartemisininPercent,DesethylamodiaquinePercent,TotalImpuritiesPercent,DissolutionArtesunatePercent,DissolutionAmodiaquinePercent,MoistureContentPercent,HeavyMetalsPPM ART-AMQ-2026-001,100.5,99.2,1.2,0.4,2.1,91.0,93.5,3.8,6.0 ART-AMQ-2026-002,98.0,101.5,1.8,0.6,2.8,89.0,92.0,4.5,10.0
ArtesunateAmodiaquineQualityChecker — Documentation
Bilingual RU/EN URS & FS. Source:
input.csv and *.description.txt. Package folder: Global/API coverage extension.Utility
ArtesunateAmodiaquineQualityChecker
Package
Global/API coverage extension
CSV fields
10
Interface
CSV → JSON
Utility description
Artesunate/Amodiaquine Quality Checker — Antimalarial Product Quality Control
ℹ️ Utility checks critical parameters of artesunate and amodiaquine combination:
• Artesunate Assay: 90.0–110.0%
• Amodiaquine Assay: 90.0–110.0%
• Dihydroartemisinin (Impurity): ≤2.0%
• Desethylamodiaquine (Impurity): ≤1.0%
• Total Impurities: ≤3.0%
• Dissolution of each component: ≥85% (Q)
• Moisture Content: ≤5.0%
• Heavy Metals: ≤20 ppm
⚠️ CRITICAL: Artesunate is highly unstable in humid environments and rapidly hydrolyzes to dihydroartemisinin.
Increased moisture (>5%) is unacceptable and leads to loss of efficacy.
Usage:
ArtesunateAmodiaquineQualityChecker.exe → demo mode
ArtesunateAmodiaquineQualityChecker.exe input.csv output.json → evaluate data
Input format:
BatchNumber,ArtesunateAssayPercent,AmodiaquineAssayPercent,DihydroartemisininPercent,DesethylamodiaquinePercent,TotalImpuritiesPercent,DissolutionArtesunatePercent,DissolutionAmodiaquinePercent,MoistureContentPercent,HeavyMetalsPPM
Example:
ART-AMQ-2026-001,100.5,99.2,1.2,0.4,2.1,91.0,93.5,3.8,6.0
— WHY IS THIS NEEDED?
Artesunate and amodiaquine combination is one of the WHO-recommended ACT regimens for malaria:
• Artesunate — artemisinin derivative, fast-acting schizontocide
• Amodiaquine — long-acting schizontocide, prevents recrudescence
• Artesunate is chemically unstable, especially in the presence of moisture
• Hydrolysis of artesunate leads to formation of dihydroartemisinin (DHA)
⚠️ CRITICAL:
• Assay 90.0–110.0% for each component — ensures parasite destruction
• Dihydroartemisinin ≤2.0% — main degradation product of artesunate
• Desethylamodiaquine ≤1.0% — degradation/metabolite product of amodiaquine
• Total Impurities ≤3.0% — overall purity indicator
• Dissolution ≥85% for each component — ensures bioavailability
• Moisture Content ≤5.0% — CRITICAL! Artesunate degrades at high humidity
• Heavy Metals ≤20 ppm — drug safety
Key features:
• Specific control of dihydroartemisinin as a marker of artesunate hydrolysis
• Control of desethylamodiaquine as a marker of amodiaquine stability
• Strict moisture limit to prevent active substance decomposition
• Compliance with WHO guidelines for antimalarial product quality
Critical parameters:
• Artesunate Assay: 90.0–110.0%
• Amodiaquine Assay: 90.0–110.0%
• Dihydroartemisinin Impurity: ≤2.0%
• Desethylamodiaquine Impurity: ≤1.0%
• Total Impurities: ≤3.0%
• Dissolution (each): ≥85% (Q)
• Moisture Content: ≤5.0%
• Heavy Metals: ≤20 ppm
💡 Usage tips:
1. Artesunate analyzed by HPLC with UV detection or ELSD
2. Dihydroartemisinin controlled by specific HPLC method
3. Moisture determined by Karl Fischer method (most accurate for low values)
4. Store in airtight packaging with desiccant
5. Perform analysis as soon as possible after opening packaging
6. If high DHA levels detected, check storage and transportation conditions
⚠️ Note: Artesunate is the hemisuccinate of artemisinin and is easily subject to hydrolysis even at room temperature in humid air. This makes moisture control the most important stability parameter for this combination. Decomposition of artesunate reduces therapy efficacy and may contribute to the development of Plasmodium resistance.URS & FS — User Requirements and Functional Specification
This document describes the controlled interface and behaviour of ArtesunateAmodiaquineQualityChecker for Artesunate/Amodiaquine Quality Checker.
Portal packages
Global/API coverage extension, Infectious Diseases QC Suite, LabEx QC laboratory utilities, Lumex QC instrument utilities, World API/FDC extension
AntimalarialCSV→JSONFDCMalariaMissingAPIQCURS & FSP2Domain limits and critical parameters
Key fragments from the source description are shown below. Before production use, limits must be verified against the approved specification, registration dossier and local SOPs.
- ℹ️ Utility checks critical parameters of artesunate and amodiaquine combination:
- • Artesunate Assay: 90.0–110.0%
- • Amodiaquine Assay: 90.0–110.0%
- • Dihydroartemisinin (Impurity): ≤2.0%
- • Desethylamodiaquine (Impurity): ≤1.0%
- • Total Impurities: ≤3.0%
- • Dissolution of each component: ≥85% (Q)
- • Moisture Content: ≤5.0%
- • Heavy Metals: ≤20 ppm
- ⚠️ CRITICAL: Artesunate is highly unstable in humid environments and rapidly hydrolyzes to dihydroartemisinin.
- BatchNumber,ArtesunateAssayPercent,AmodiaquineAssayPercent,DihydroartemisininPercent,DesethylamodiaquinePercent,TotalImpuritiesPercent,DissolutionArtesunatePercent,DissolutionAmodiaquinePercent,MoistureContentPercent,HeavyMetalsPPM
- ⚠️ CRITICAL:
- • Assay 90.0–110.0% for each component — ensures parasite destruction
- • Dihydroartemisinin ≤2.0% — main degradation product of artesunate
- • Desethylamodiaquine ≤1.0% — degradation/metabolite product of amodiaquine
- • Total Impurities ≤3.0% — overall purity indicator
- • Dissolution ≥85% for each component — ensures bioavailability
- • Moisture Content ≤5.0% — CRITICAL! Artesunate degrades at high humidity
URS — User Requirements Specification
| ID | Requirement | Criticality | Acceptance criterion |
|---|---|---|---|
| URS-001 | The utility shall accept an input.csv file for Artesunate/Amodiaquine Quality Checker with headers defined in the data contract. | High | The file is processed without manual header editing. |
| URS-002 | The utility shall perform deterministic QC evaluation without machine learning and without probabilistic conformance decisions. | High | Identical input data, rule version and configuration produce reproducible results. |
| URS-003 | The utility shall validate mandatory fields, data types, ranges, units and domain plausibility. | High | Schema, conversion and range errors are explicitly reported. |
| URS-004 | The utility shall apply domain limits and rules from the description, approved specification, registration dossier and local SOPs. | High | Each check has PASS/WARNING/FAIL and a clear message. |
| URS-005 | The utility shall generate output.json with machine-readable results, source values, warnings, failures and critical findings. | High | JSON is suitable for LIMS/ELN/MES integration and QA/QC review. |
| URS-006 | The utility shall preserve traceability between batch/sample, input file, applied rules and final status. | High | Output contains identifiers, checked parameters and audit metadata. |
| URS-007 | The documentation shall support IQ/OQ/PQ, CSV/CSA and review by internal QA or inspectors. | Medium | URS, FS, input/output contract and test scenarios are supplied with the utility. |
| URS-008 | The utility shall be used as a QC decision-support tool and not as a substitute for approved specifications and QA/QP release decision. | Medium | Documentation states change control and limit-verification expectations. |
input.csv contract
| # | Field | Type | Sample | Purpose |
|---|---|---|---|---|
| 1 | BatchNumber | string / controlled vocabulary | ART-AMQ-2026-001 | Batch or lot identifier used for traceability. |
| 2 | ArtesunateAssayPercent | decimal | 100.5 | Quantitative content/potency; critical release parameter. |
| 3 | AmodiaquineAssayPercent | decimal | 99.2 | Quantitative content/potency; critical release parameter. |
| 4 | DihydroartemisininPercent | decimal | 1.2 | Controlled input parameter for deterministic QC rules. |
| 5 | DesethylamodiaquinePercent | decimal | 0.4 | Controlled input parameter for deterministic QC rules. |
| 6 | TotalImpuritiesPercent | decimal | 2.1 | Impurity/related-substance parameter; purity and degradation control. |
| 7 | DissolutionArtesunatePercent | decimal | 91.0 | Dissolution/release parameter relevant to bioavailability and batch quality. |
| 8 | DissolutionAmodiaquinePercent | decimal | 93.5 | Dissolution/release parameter relevant to bioavailability and batch quality. |
| 9 | MoistureContentPercent | decimal | 3.8 | Quantitative content/potency; critical release parameter. |
| 10 | HeavyMetalsPPM | decimal | 6.0 | Elemental impurity/metal parameter relevant to safety. |
BatchNumber,ArtesunateAssayPercent,AmodiaquineAssayPercent,DihydroartemisininPercent,DesethylamodiaquinePercent,TotalImpuritiesPercent,DissolutionArtesunatePercent,DissolutionAmodiaquinePercent,MoistureContentPercent,HeavyMetalsPPM ART-AMQ-2026-001,100.5,99.2,1.2,0.4,2.1,91.0,93.5,3.8,6.0 ART-AMQ-2026-002,98.0,101.5,1.8,0.6,2.8,89.0,92.0,4.5,10.0
Input validation rules
| ID | Field | Rule | Criticality |
|---|---|---|---|
| VR-001 | BatchNumber | The field shall match an approved dictionary or accepted string representation. | High |
| VR-002 | ArtesunateAssayPercent | The value shall be numeric, non-empty and domain-plausible for the approved specification. | High |
| VR-003 | AmodiaquineAssayPercent | The value shall be numeric, non-empty and domain-plausible for the approved specification. | High |
| VR-004 | DihydroartemisininPercent | The value shall be numeric, non-empty and domain-plausible for the approved specification. | Medium |
| VR-005 | DesethylamodiaquinePercent | The value shall be numeric, non-empty and domain-plausible for the approved specification. | Medium |
| VR-006 | TotalImpuritiesPercent | The value shall be numeric, non-empty and domain-plausible for the approved specification. | High |
| VR-007 | DissolutionArtesunatePercent | The value shall be numeric, non-empty and domain-plausible for the approved specification. | Medium |
| VR-008 | DissolutionAmodiaquinePercent | The value shall be numeric, non-empty and domain-plausible for the approved specification. | Medium |
| VR-009 | MoistureContentPercent | The value shall be numeric, non-empty and domain-plausible for the approved specification. | High |
| VR-010 | HeavyMetalsPPM | The value shall be numeric, non-empty and domain-plausible for the approved specification. | Medium |
FS — Functional Specification
| ID | Function | Implementation |
|---|---|---|
| FS-001 | CLI execution | Support execution modes: demo mode without arguments and production mode input.csv output.json. |
| FS-002 | CSV import | Read input.csv in UTF-8/CSV-compatible format and validate header and expected columns. |
| FS-003 | Schema validation | Check mandatory fields, column count, unknown key fields and empty mandatory values. |
| FS-004 | Type conversion | Convert numeric, flag and text values; invalid format is recorded as a row-level error. |
| FS-005 | Domain rule engine | Apply rules for Artesunate/Amodiaquine Quality Checker, including critical limits from the description and approved specification. |
| FS-006 | Status aggregation | Produce final status: FAIL for critical failure, WARNING for non-critical deviation, PASS for conformance. |
| FS-007 | JSON export | Write output.json with detailed checks, source values, warnings, failures and critical findings. |
| FS-008 | Audit support | Keep result structure suitable for review, deviation investigation and calculation reproduction. |
| FS-009 | Integration contract | Support the scenario LIMS/ELN/MES → input.csv → utility → output.json → portal/admin review. |
| FS-010 | Fallback mapping | If the combined utility is not deployed, use component checks: artesunate-quality-checker, amodiaquine-quality-checker plus generic Lumex/LabEx checks. |
| FS-011 | Error handling | Return explicit messages for missing file, empty CSV, invalid schema, output write failure and invalid format. |
Example output.json
{
"utilityId": "artesunate-amodiaquine-quality-checker",
"utilityFolder": "ArtesunateAmodiaquineQualityChecker",
"package": "Global/API coverage extension",
"overallStatus": "PASS|WARNING|FAIL",
"sourceFile": "input.csv",
"processedAtUtc": "2026-07-02T00:00:00Z",
"checks": [
{
"parameter": "BatchNumber",
"value": "ART-AMQ-2026-001",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-001"
},
{
"parameter": "ArtesunateAssayPercent",
"value": "100.5",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-002"
},
{
"parameter": "AmodiaquineAssayPercent",
"value": "99.2",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-003"
},
{
"parameter": "DihydroartemisininPercent",
"value": "1.2",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-004"
},
{
"parameter": "DesethylamodiaquinePercent",
"value": "0.4",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-005"
},
{
"parameter": "TotalImpuritiesPercent",
"value": "2.1",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-006"
},
{
"parameter": "DissolutionArtesunatePercent",
"value": "91.0",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-007"
},
{
"parameter": "DissolutionAmodiaquinePercent",
"value": "93.5",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-008"
},
{
"parameter": "MoistureContentPercent",
"value": "3.8",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-009"
},
{
"parameter": "HeavyMetalsPPM",
"value": "6.0",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-010"
}
],
"criticalFindings": [],
"warnings": [],
"audit": {
"inputHash": "sha256:<calculated at runtime>",
"rulesVersion": "<utility executable version>",
"documentation": "ArtesunateAmodiaquineQualityChecker.documentation.html"
}
}
Traceability matrix
| URS | FS | Test | Evidence |
|---|---|---|---|
| URS-001 | FS-001, FS-002 | OQ-001 | Verify execution and import of valid input.csv. |
| URS-002 | FS-005, FS-006 | OQ-004 | Repeat the same dataset and compare output.json. |
| URS-003 | FS-003, FS-004, FS-011 | OQ-002, OQ-003 | Verify missing columns and invalid types. |
| URS-004 | FS-005, FS-006 | OQ-004, PQ-001 | Verify critical deviations on real/boundary data. |
| URS-005 | FS-007, FS-009 | OQ-005 | Verify JSON schema and downstream-system suitability. |
| URS-006 | FS-008 | OQ-006 | Verify identifiers and audit metadata. |
| URS-007 | FS-008, FS-011 | IQ-001, OQ-007 | Verify documentation completeness and control evidence. |
| URS-008 | FS-005, FS-008, FS-010 | PQ-002 | Verify review workflow and no replacement of QA decision. |
IQ/OQ/PQ test scenarios
| ID | Scenario | Expected result |
|---|---|---|
| IQ-001 | Verify executable, input.csv, documentation and checksum availability. | Delivery set is complete; version is recorded. |
| OQ-001 | Valid sample row from input.csv. | PASS or acceptable WARNING according to rules. |
| OQ-002 | Remove a mandatory CSV column. | Schema error or FAIL with missing-column reference. |
| OQ-003 | Place a non-numeric value into a numeric field. | Type-conversion error with row/field reference. |
| OQ-004 | Set a critical parameter outside the limit. | FAIL and critical finding. |
| OQ-005 | Verify output.json structure. | All mandatory sections are present and JSON is valid. |
| OQ-006 | Verify batch/sample traceability. | Input and result identifiers match. |
| OQ-007 | Verify fallback/decomposition for combined APIs. | Component checks are explicitly documented. |
| PQ-001 | Verify 3–5 real user batches/samples. | Result is confirmed by QC/QA review. |
| PQ-002 | Verify deviation workflow and manual QA decision. | Utility supports review but does not replace approved decision. |
QA/QC and change control
- Do not rename columns without updating validator, documentation and test set.
- Retain input.csv, output.json, executable version and checksum.
- Before production use, perform IQ/OQ/PQ or equivalent CSV/CSA verification.
- Critical limits shall be verified against the approved specification, registration dossier and local SOPs.
- For combination products, document whether the specialized FDC utility or fallback component checks were used.
- The utility provides structured QC decision support; final release decision remains with QA/QP and approved procedures.
Included in packages
Global API & Biosimilars QC Suite
Package for high-demand global APIs, generics and biosimilars, including fixed-dose combinations and biological products.
OpenInfectious Diseases QC Suite
QC utility package for infectious diseases: antibacterial, antiviral, antifungal and antiparasitic products, microbiology, sterility, endotoxins, viral safety and vaccine release checks.
OpenWorld API Extension QC Suite
Extended package for 130 additional high-demand APIs and biological products prepared as a market-coverage backlog.
Open