apimanufacturing

cGMP Quality Systems

All the Safeguards You Require

PCI Maintains cGMP Quality Systems compliant with ICH Q7A
and 21 CFR 211 requirements for pharmaceuticals manufacturing

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
  • Assist FDA inspectors during audits of our facilities

QUALITY CONTROL

  • Cooperate with customer 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

Quality Control
"Quality", Our Customer's Expectation, Our Primary Performance Requirement

As a leading supplier to the Life Science Industry, PCI Synthesis recognizes the importance of adhering to the highest standards for quality.

 

To ensure that we meet or exceed our customers' requirements, PCI Synthesis 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

PCI Synthesis also provides 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)

Every project undertaken on the customer's behalf is safeguarded by sophisticated on-site quality control procedures and analytical services.