FFuzkk Atlas of China
#19Official Top 100

Humanwell Healthcare

人福医药集团股份公司

#19

Chemical medicines and finished dosage formsHormones and high-potency APIsSterile products

Manufacturing profile

Chemical medicines and finished dosage forms
Hormones and high-potency APIs
Sterile products

Selection basis

The company is included in the official 2024 ranking of the 100 largest Chinese pharmaceutical-industry enterprises by main-business revenue.

The FUZKK fit shows potential applicability of existing utilities. It does not claim actual use of FUZKK, specific installed equipment models or a product not confirmed by the public company profile.

Representative manufacturing and QC chain

  1. 1Raw-material receipt and identification
  2. 2Dispensing, blending and granulation
  3. 3Tableting, encapsulation or solution preparation
  4. 4Packaging and labelling
  5. 5HPLC, GC, KF, ICP/AAS, dissolution and stability QC
  6. 6WFI, clean steam and cleanroom HVAC
  7. 7Solution preparation and bioburden control
  8. 8Sterile filtration
  9. 9Isolator/RABS filling or lyophilisation

Relevant FUZKK packages

Global API & Biosimilars QC SuiteChina: national essential medicines QC packageEndocrinology QC SuiteLabEx QC SuiteSterile Medical Devices SuiteLumex QC Suite

Product/API utilities

Assay & Impurities Result ReviewerWater For Injections Quality CheckerFill Volume & Container Closure CheckerEstradiol Quality CheckerDexamethasone Quality CheckerBetamethasone Quality CheckerDesogestrel Quality Checker

Lumex — instrumental QC

Genotoxic Impurity Screener M7Content Uniformity Acceptance ValueDissolution Profile f2 CalculatorCE Chiral Separation CheckerAAS Elemental Impurities Class1LabWare CDS Bridge ConnectorAAS Catalyst Residues Pd Pt RhAAS Glass Leachables TestCE Inorganic Ions Analyzer

LabEx — laboratory QC

Assay & Impurity HPLC Quality CheckerResidual Solvents GC Quality CheckerWater Content KF Quality CheckerElemental Impurities ICP Quality CheckerContent Uniformity Quality CheckerDissolution Apparatus 1 & 2 Quality CheckerStability Condition Monitoring Quality CheckerChiral Purity HPLC Quality CheckerSterility Test Membrane Filtration Quality CheckerBacterial Endotoxins LAL Quality Checker

Medical Devices — equipment and software lifecycle

Process Validation CheckerData Integrity Security CheckerChange Control Impact CheckerRelease Readiness CheckerSupplier Evaluation CheckerCalibration Status CheckerRequirement Traceability Checker

Suggested first pilot

  1. Confirm one real product, method or recurring QC review.
  2. Record the instrument, export format and current specification.
  3. Select 3–7 utilities from the map above.
  4. Run a PASS/FAIL sample and agree the expected output.
  5. After user validation, expand the scope.

Mapping boundary

The FUZKK fit shows potential applicability of existing utilities. It does not claim actual use of FUZKK, specific installed equipment models or a product not confirmed by the public company profile.

Methodology