API Manufacturing

Quality Assurance / Regulatory

PCI’s FDA inspected facilities are fully compliant with ICHQ7 and CFR Part II.

API Manufacturing and cGMP Polymer Manufacturing

PCI maintains a robust and comprehensive cGMP quality system. We have been audited by all of our customers, quality professionals (QP’s), and regulatory agencies. PCI’s Quality Assurance team insures the high quality manufacturing for all our commercial API and clinical drug substance products.

Regulatory

  • Interaction with regulatory bodies (FDA and equivalents)
  • Every project is assigned an internal QA professional who works closely with the sponsor’s regulatory representative
  • Internally prepare all Drug Master Files (DMF’s)
  • Assist with all aspects of sponsor CMC filings
  • Continuous auditing of all critical raw material supplier

R&D Support

  • R&D Team that develops processes that meet ICH guidelines and USP specifications
  • DOE studies to fully understand critical process parameters
  • Production of qualified reference standards
  • Employ prep-chromatography to isolate impurities and evaluate for genotoxicity
  • Kilo labs for process validation and process confirmation

Facilities

  • Class 100,000 kilo suites for pre-clinical and clinical material (Phase I-II)
  • 20,000 gal of manufacturing capacity for late phase (Phase III) and commercial manufacturing
  • Class 100,000 finishing and packaging areas for final products
  • On-site cGMP laboratories fully staffed and equipped for raw material testing, in process testing, final release testing, method development and full stability testing
  • Capabilities to develop and manufacture API’s for injectables, opthalmics and controlled substances.

FDA Audits

  • Newburyport – April 2006, November 2008, May 2010, August 2011, December 2012, September 2013 and April 2015
  • Devens – October 2005; June 2008
  • Leominster – February 2002, November 2003, December 2004
  • Pre-Approval Inspection (PAI) – October 2002, October 2005 and April 2006, August 2011, Dec 2012, Sept 2013, April 2015