cGMP Manufacturing

Avista Pharma operates multiple cGMP kilogram-scale labs (kilo labs) to demonstrate particular manufacturing processes and to supply critical API for preclinical and clinical studies. Our experienced Quality Assurance (QA) department ensures that detailed documentation, adherence to SOPs/federal guidelines and laboratory controls are maintained.

 

cGMP Services Include:

  • Preparation of active pharmaceutical ingredients (API’s) under cGMP controls
  • Development and outsourced manufacturing of regulatory starting material (RSM)
  • Phase-appropriate analytical method development and validation
  • Materials characterization and release testing
  • Process validation
  • Cost of goods (COGS) analysis
  • Technology transfer
  • CMC Quality eCTD module documentation for Investigational New Drug (IND) and Investigational Medicinal Product Dossier (IMPd) submissions

Avista Pharma’s Quality Management System Provides:

  • Comprehensive Quality Agreements
  • Phase-appropriate cGMP
  • Utilization of quality risk management principles
  • Commitment to quality and continuous improvement