Finished Pharmaceutical Product

Product & Process Division

Expertise and Services capability supports you up to the final stage

DOC Expertise and Services capability supports you up to the final stage of your operations: the final pharmaceutical product release or the late phases of its developments. Studies or release analysis are carried out under the full GMP compliance to guarantee your same Quality Standards.

  • Finished product formulation Development
    • Stability Study: executed using qualified climatic chambers in which customized or standard conditions are applied (25°C/60% R.H, 30°C /65%R.H, 30°C/75% R.H and 40°C/75% R.H), simulation Accelerated and/or Real Time storage conditions studies
    • Accelerated and Real time Studies
    • Accelerated and Real time Studies
    • Photo-Stability
    • Oxidation Studies
    • Leachables Studies
    • Antimicrobial Effectiveness Testing
    • Antimicrobial Susceptibility Testing

For Finished product, we can offer the following analysis for its final release:

  • Sterility Test Studies
  • Endotoxin Limit Test
  • Microbial count (TAMC, TYMC)
  • Microbial Identification for
    • Bacteria, Yeasts and Molds and Mycoplasma
    • Biochemical or PCR based Methods
  • Elemental Impurities (ICH Q3D)
    • Data collection
    • Gap Analysis & Matrix Elaboration
    • GMP Analytical Screening
    • Remediation Plan
    • Product Risk Assessment

 

  • Titre
  • Water Content
  • Solvent Residues
  • Heavy Metals
  • Impurities
  • AD/Mix Studies
  • Laboratory Data Integrity

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