Regulatory Compliance and Quality Assurance
The design and operation of AFC’s production facilities comply with U.S. Federal, State of California and other worldwide regulatory requirements for the production of pharmaceutical chemicals in accordance with cGMPs.

AFC’s regulatory status is maintained via comprehensive, compliant quality systems. The U.S. Food and Drug Administration (FDA) and other U.S.-based regulatory authorities, as well as the Pharmaceuticals and Medical Device Agency (PMDA) in Japan, have audited us routinely with excellent results. In addition to meeting the highest regulatory standards for our own operations, we offer our clients additional services that include:

  • Drug Master Files (DMFs) preparation and maintenance
  • Input and review of Chemistry, Manufacturing & Controls (CMCs) sections of New Drug Applications (NDAs)
  • Development and Validation of Analytical Methods
  • Stability and Microbiology Testing
AFC’s Quality Control laboratories are fully equipped with the latest analytical equipment to support production and ensure the highest level of quality in the final product:
  • Gas Chromatography (GC) — Static Headspace/Gas Chromatography (HS/GC) — Gas Chromatography/Mass Spectrometry (GC/MS)
  • High-Performance Liquid Chromatography (HPLC)
  • Liquid Chromatography/Mass Spectrometry (LC/MS)
  • Ion Chromatography
  • Nuclear Magnetic Resonance (NMR) (300 MHz)
  • Fourier Transform Infrared (FTIR) — Ultraviolet-Visible Spectroscopy
    (UV-VIS) — Polarimeter
  • Particle Size Analyzer
  • Differential Scanning Calorimetry (DSC)/Thermogravimetric
    Analysis (TGA)/RC-1
AMPAC Fine Chemicals Regulatory Compliance and Quality Assurance
AFC manufactures pharmaceutical
chemicals for the global market
at state-of-the-art facilities located
on a large security-controlled site
in Rancho Cordova, California.
Learn More