Life Sciences Industries
Pharmaceutical, Biotechnology, and Healthcare
Engineering & Manufacturing Solutions
GP provides engineering services to the life sciences industry that are associated with the manufacturing of new chemicals, as well as the maintenance of existing equipment. Our services are typically offered to operations, tech ops, plant engineering, and safety-regulatory compliance organizations.
Operations
- Design and analysis of chemical processes for the manufacturing of "new" campaigns:
- Review the process chemistry
- Develop the preliminary flow diagrams using good engineering practices to ensure accurate construction/fabrication of value engineering of processes
- Act as the owner's agent during the construction/fabrication process to ensure designs are built in accordance with plans and that the full value of the project is recognized
- Develop and/or refine operating procedures to reflect current practices and satisfy regulatory (GMP) requirements:
- Review current documents
- Identify gaps between the documents and actual practices
- Provide revised procedures that clearly identify the operation of systems and processes
Plant Engineering
- Develop maintenance activities to streamline and manage plant maintenance needs:
- Develop plant-wide process equipment documentation through detailed reviews
- Obtain the original equipment manufacturer (OEM) data for facility equipment and assess the current condition of the equipment using the OEM data
- Develop maintenance procedures
- Review maintenance inspection frequency
- Optimize systems incorporating storehouse management, computerized maintenance management systems (CMMS), and enterprise resource planning (ERP) software
Regulatory
- Review process and process design change to satisfy regulatory compliance, including elements of:
- Process safety and risk management
- Pharmaceutical MACT (Maximum Achievable Control Technology) standards (40 CFR Part 63, Subpart GGG)
- Environmental permitting
- Documenting and commissioning aspects of processes to satisfy GMP requirements and reduce start-up time
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