From Risk Identification to Compliant Operations: The Innovative Path of High Potent Medicine Production

High potent medicines offer good profits due to high entry barriers. However, with rising environmental and occupational health standards, traditional production facilities and operational methods face increasing regulatory challenges. Many enterprises must reassess their control strategies against regulatory requirements. After discussions with several companies, key gaps were identified:

-  Compliance of HVAC Design

-  Material segregation of high potent materials

-  Application of high containment systems

-  Science-based Cleaning Validation

-  Proper PPE

-  Periodic Environmental Monitoring and Healthy Check

When conducting high potent production operations, to achieve safe operations and high-quality products, some companies overly rely on high containment equipment and ventilation systems without assessing product, process, and facility risks. This approach lacks scientific risk assessment, potentially increasing costs without ensuring compliance, which is a common high potent control strategy in many enterprises, but it won’t bring high regulation compliance even if it requests high capital investment and operation cost.

So, how can we balance cost and regulatory compliance?

We need to go back to the basics: understanding the toxicity risks of the product, identifying risks in the manufacturing process, and re-evaluating control strategies for production operations. Manufacturers of high potent products must have a strong sense of responsibility—not only to patients but also to employees. Thorough risk identification at the early stage will not increase project investment or prolong construction timelines; instead, it will significantly reduce risks in projects and operations, enhancing the competitiveness of the enterprise and its products in the market. Please contact AUSTAR for comprehensive solutions.