EHS vs. GMP：Front-End Engineering Consulting Driving The Enterprise Internationalization

Background：

The client is one innovative company engaged in the research, development, production, and sales of innovative drugs. The company has more than 10 drug production facilities domestically, with robust production capabilities and extensive market coverage. Its products are sold in over 100 countries and regions worldwide, with 36 product varieties achieving annual sales exceeding 100 million RMB each, demonstrating its market competitiveness and influence.

To achieve its internationalization strategy, the client plans to build new cytotoxic workshops and anti-tumor API workshops. The client places great emphasis on the Environmental, Health, and Safety (EHS) assessment of new facilities to minimize environmental and employee health impacts during operations. At the same time, they strictly adhere to GMP regulations, striving to balance EHS assessment with GMP compliance to ensure that every step of production meets safety and quality standards.

Project Info.：

Project name：EHS Risk Assessment for high potent project

OEB level：OEB5/OEB4

Facility type：Green filed

Project area: 130,000 + m2

Project-Driven：Compliance (NMPA,FDA,EU GMP）Safety, Energy Saving

Service Scope：

•       EHS Risk Assessment

•       GMP Design Review

•       Cytotoxic Product Risk Assessment & EHS Document Review

•       Sterility Assurance Risk Assessment & Document Review

•       Risk-based Verification Review

Project Challenges：

•       Facility Requirements: FDA certification with limited production experience for high potent product

•       Risk Assessment and Design Review: Balancing EHS and GMP requirements

•       Document System: Ensuring compliance with Chinese, American, and European pharmaceutical regulatory standards

Our Capabilities：

•       Reduce high potent area size based on risk assessment

•       Energy saving by reducing the full ventilated HVAC system

•       Energy saving and emission reduction

•       EHS vs. GMP