At PCI, we are committed to producing the highest quality products possible. As a leading manufacturer of commercial active pharmaceutical ingredients, clinical trial materials and advanced intermediates for Life Science companies, we have always prided ourselves in our Quality Assurance and Quality Control organizations. With eight successful FDA inspections and six pre-approval audits of our cGMP facilities, we are better positioned than ever to deliver world-class quality. We have many systems that work together to ensure that all of our products meet and/or exceed their specifications. This is accomplished by having the correct documents in place so that all parts of the process run smoothly and correctly, by checking finished documents for errors or deviations, and by ensuring that all needed testing is completed and documented.
cGMP Quality Systems
PCI maintains cGMP Quality Systems compliant with ICH Q7 since November of 2000
QA PROGRAMS
- 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
COMPLIANCE PROGRAMS
- 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
FDA Audits:
- Newburyport - April 2006, April 2008, May 2010, August 2011
- 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
QC PROGRAMS
As a leading supplier to the Life Science Industry, PCI Synthesis recognizes the importance of adhering to the highest standards for quality.
- Cooperate 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
- In-house stability program
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)
Through a cooperative agreement with local universities such as Clark University in Worcester, MA, PCI also provides advanced non-GMP testing techniques including:
- Atomic Absorption (flame and graphite) spectroscopy
- X-ray Crystallography
- Nuclear Magnetic Resonance Spectroscopy
- Differential Scanning Calorimetry
- Mass Spectroscopy
For c-GMP testing that is outside of PCI's capabilities, PCI has approved suppliers that will complete all tests.
Every project undertaken on the customer's behalf is safeguarded by sophisticated on-site quality control procedures and analytical services.
