cGMP Quality System Solutions

From conceptual design to day-to-day

Technical & Operational Reviews

Facilities and manufacturing operations in cGMP regulated industries including Biotech, Pharmaceutical, Dietary Supplement, and Food & Beverage present unique and complex challenges compared to the typical corporate built environment. cGMP operations require robust SOPs and specialized staff training as well as facilities designed, constructed, and maintained to ensure adequate controls for validated systems, sanitation, contamination control, personnel and process flows, and supply chain security.

These expectations can often seem to conflict with the best practices typically associated with facility
operations. Facilities Consulting NW is uniquely positioned to leverage a combination of experience ranging from Life Science research and product development through Clinical Trials and scale up to Sterile and Non-sterile manufacturing to help clients meet these challenges.

extensive Operational and technical reviews for

cost-effective strategic and technical solutions

From initial facility conceptual design through day-to-day operations, Facilities Consulting NW delivers customized cost-effective strategic and technical solutions that meet regulatory expectations.
  • Operational reviews of facility operations, housekeeping, security, sanitation, and support services
  • Technical reviews of facility design, production equipment layout and manufacturing processes
  • Facility, equipment, and cleaning validation including DQ/IQ/OQ/PQ protocol development and execution
  • Facility, process, and cleaning SOP development
  • Staff, contractor, and vendor cGMP training
  • ISO 17025 Calibration program implementation and management
  • 21 CFR Part 11 compliant preventative maintenance program development
  • Quality Control Laboratory program reviews
  • FDA, TGA, and NSF pre-inspection preparation, mock audits, and gap-analysis
  • Quality System reviews