FFuzkk Atlas of China
#64Official Top 100

Hongri Pharma

天津红日药业股份有限公司

#64

TCM and herbal productsSterile products

Manufacturing profile

TCM and herbal products
Sterile products

Region: Tianjin

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. 1Receipt and identification of botanical materials
  2. 2Extraction and concentration
  3. 3Drying, blending and granulation
  4. 4HPLC/GC fingerprinting
  5. 5Pesticides, mycotoxins, metals, ash and moisture 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

Herbal / TCM / Ayurveda Instrumental QC SuiteBritish Herbal Pharmacopoeia QC SuiteLabEx QC SuiteSterile Medical Devices SuiteChina: national essential medicines QC package

Product/API utilities

Chromatographic Fingerprint Similarity CheckerHerbal Chromatographic Fingerprint AnalyzerHerbal Multi Component Assay CheckerTCMDecoction Consistency CheckerHerbal Pesticide Residue CheckerHerbal Mycotoxin Limit CheckerHerbal Heavy Metals Screening CheckerHerbal Extract Solvent Residue CheckerTotal Ash In Herbal CheckerWater For Injections Quality CheckerFill Volume & Container Closure Checker

Lumex — instrumental QC

AAS Heavy Metals Plant MaterialFluorat Aflatoxin ScreenerFluorat Mycotoxins OchratoxinCE Inorganic Ions AnalyzerLabWare CDS Bridge ConnectorAAS Glass Leachables Test

LabEx — laboratory QC

Water Content KF Quality CheckerSterility Test Membrane Filtration Quality CheckerBacterial Endotoxins LAL Quality CheckerParticle Count Injection USP <788> Quality CheckerFilter Integrity Test Quality CheckerPackage Integrity & Leak Test Quality CheckerOsmolality Quality CheckerEnvironmental Monitoring Cleanroom Quality CheckerAssay & Impurity HPLC Quality CheckerElemental Impurities ICP Quality Checker

Medical Devices — equipment and software lifecycle

Supplier Evaluation CheckerCalibration Status CheckerProcess Validation CheckerChange Control Impact CheckerData Integrity Security 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