AFC maintains a culture of compliance through multiple successful regulatory and customer inspections. AFC’s Quality System is composed of our highly experienced Regulatory and Quality Control Teams; this system ensures that our products meet all applicable quality requirements. Separately, AMPAC’s Analytical Services both support AFC’s CMO customers and independently support the global pharmaceutical consumer base with contracted starting material, drug substance, and drug product testing, stability and release services.
Our production facilities comply with U.S. Federal, State, and other worldwide regulatory requirements for the production of pharmaceutical chemicals in accordance with cGMPs.
We are routinely audited by multiple regulatory authorities including the U.S. Food and Drug Administration (FDA), Japan’s Pharmaceuticals and Medical Device Agency (PMDA), and the European Medicines Agency (EMA). AFC has voluntarily enrolled in CA-OSHA safety programs and provides FDA training sessions to new FDA auditors. AFC has sixteen PAIs approved since 2008.
AFC’s Quality Control laboratories include the following equipment:
- Gas Chromatography (GC)- Static Headspace/Gas Chromatography (HS/GC) & Gas Chromatography/Mass Spectrometry (GC/MS)
- High-Performance Liquid Chromatography (HPLC/UPLC)
- 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
- Actively training FDA inspectors at AFC
- Attended by over 50 employees of FDA and CA Board of Pharmacy
- Two-day Training Events
- Poster Board Sessions Provided on Warehouses, Laboratories, Production Plant, and Development Facilities
- Presentations on GMP Topics of Interest
Excellent Relationship with Other Agencies
- Frequent interaction with state and local environmental agencies
- HAZMAT partnership with local emergency responders
- Voluntary enrollment in CA-OSHA safety enhancement program
- Direct interface with local US DEA office
AMPAC Analytical specializes in analytical development and testing of cGMP Intermediates, APIs, and Drug Products. For more information about our contract analytical services, please visit www.ampacanalytical.com.