Facility

cGMP Manufacturing

We maintain cGMP quality systems compliant with ICH Q7 and fully compliant with CFR Part 11.

API Manufacturing and cGMP Polymer Manufacturing

PCI maintains cGMP quality systems compliant with ICH Q7 so you can feel confident that your development will have all of the safeguards you require. Our class 100,000 finishing and packaging areas ensure high quality manufacturing for all our API and drug substance products.

QUALITY ASSURANCE

  • Validation of all critical processes and procedures
  • On-going internal auditing, customer auditing, and review
  • Documentation and change control
  • Training all PCI Synthesis personnel in quality principles and job skills
  • Guide and support the processes in every facet of our operation

QUALITY COMPLIANCE

  • Interaction with Regulatory bodies (FDA and international equivalents)
  • Prepare, file, and revise Drug Master Files for all our API’s
  • Work with customer’s Quality Assurance personnel during audits of our facilities

QUALITY CONTROL

  • Cooperate with client to set specifications
  • Develop, validate, and operate robust analytical procedures
  • Sample, test, and control all raw materials, intermediates and final products
  • Analytical support for all manufacturing operations
  • Disposition and distribution of manufactured products

To ensure that we meet or exceed our clients’ requirements, PCI employs the most advanced analytical techniques available. These include:

  • Infrared (IR) and Ultraviolet/Visible Spectroscopy (UV/VIS)
  • High Pressure Liquid Chromatography (HPLC)
  • Gas Chromatograpy (GC)
  • Total Organic Carbon Analysis (TOC)
  • Auto Titration
  • A wide array of Wet Chemistry Analyses
  • Heat Stability and Aging Tests
  • Karl Fischer (KF)
  • GC/MS

At PCI, every project we undertake is safeguarded by sophisticated on-site quality control procedures and analytical services. We provide advanced testing techniques through cooperative agreements, including:

  • Atomic Absorption (flame and graphite) spectroscopy
  • X-ray Crystallography
  • Nuclear Magnetic Resonance Spectroscopy (NMR)
  • Differential Scanning Calorimetry (DSC)
  • Mass Spectroscopy (MS)