pi specializes in commissioning and start-up of production facilities, process equipment and control systems. We plan and coordinate the quality assurance activities of vendors, construction contractors, owners and contract resources effectively. We develop commissioning inspection and test procedures; forms and protocols tailored to project specifications to guide and document activities. We apply risk management practices to narrow the focus of qualification (client procedures permitting). We integrate our work within the overall project schedule, establishing an optimal commissioning sequence to minimize project delivery timelines.
When problems arise, we take charge and take responsibility. We verify that re-testing is thorough, documented and completed quickly to stay on schedule. Whether your needs are comprehensive planning and execution for a new facility, modifying a small system, or getting back into production after a shutdown, pi provides a comprehensive set of essential services.
Our experience encompasses bulk pharmaceutical chemicals, biotech process equipment, sterile bulk formulation, aseptic processing, sterile finished dosage forms, dry products, cleaning, sterilization, computer systems, animal facilities, clinical facilities, QC laboratories, and other regulated (FDA, EMA, SFDA, etc…) manufacturing facilities.
At pi, we understand how to leverage the quality assurance activities of vendors, factory acceptance tests, construction quality assurance and commissioning activities to avoid duplication and streamline the final validation inspections and tests. This shortens the final stages of project delivery, when just about everything is on the critical path. The result – faster time to market for your product!
Our services include:
- Commissioning and Validation Planning
- Risk Assessments
- Commissioning Project Management
- Factory Acceptance Testing
- Commissioning Procedures, Inspection and Test Forms
- Equipment and System Installation Inspections
- Start-Up and Troubleshooting
- Commissioning Testing
- Validation Protocol Writing
- Protocol Field Execution and Reports
- Computer Validation
- Cleaning Validation, Sterilization Validation
- Product Validation