Quality Assurance

Compliance to the GCP for clinical studies and the GMP for production, is constantly monitored by periodic internal inspections to the studies and the production processes. Maintenance, upgrading and continuous growth of know how is made possible by regular customer audits, representing a rare opportunity for analysis and comparison with the greatest representatives of the quality and manufacturing sector. The results of these audits through the respective services of Quality Assurance are further evidence that Abiogen Pharma’s Pharmaceutical Factory offers an adequate and consistent sphere of quality assurance.

Main Chemical Analysis and Physical-Chemical techniques

 

Chemical and Physical Chemical Analysis

  • Tin Layer Chromatography
  • High Performance Liquid Chromatography (HPLC)
  • Ionic Chromatography
  • Gas-Chromatography
  • Gas-Chromatography Head Space Tecnic
  • UV-VIS Spectroscopy
  • Infrared Spectroscopy (FTIR)
  • Atomic Absorpion Spectrometry
  • NIR Spectroscopy
  • TOC Determination
  • Visible and Subvisible Particolate Contamination
  • Acid-base titrations
  • Complexometric titrations
  • Redox titrations
  • Potentiometry
  • Conductometry
  • Polarimetry & Optical Rotation
  • Microwave Mineralization
  • Steam Distillation
  • Physical Characterization (melting point, refractive index, density, viscosity)

Biologic and Microbiologic Controls

  • Sterility test
  • Bioburden
  • LAL test
  • Like Heparin activity determination
  • Biological assay of actives

Technical-Pharmaceutical Controls

  • Loss on drying
  • Disaggregation
  • Dissolution
  • Friability
  • Tablets Hardness, Thickness, Diameter
  • Disaggregation time of suppository
  • Hardness of Ampoules

Process Validation

  • Process Validation

Technology Transfer and Validation

  • Trasferimento Tecnologico dallo Sviluppo alla produzione Pilota
  • Trasferimento Tecnologico di prodotti commerciali
  • Lotti dimostrativi
  • Trasferimenti Analitici
  • Convalida di Processo 

Quality Assurance

 

Main activities

  • Product release
  • Process validation
  • Cleaning validation
  • Deviations & CAPA
  • Compliants & Recall
  • Environmental & utilities monitoring
  • Supplier audits
  • Self Inspection
  • Documentation control
  • Analytical tranfer
  • On-going stability studies
  • Chemical analysis
  • Microbiology analysis
  • Sterility testing
  • Computer systems validation