The successful planning and execution of GMP-compliant production facilities begins with a solid foundation in the concept phase. This presentation illuminates the critical role that early integration of GMP requirements during the Concept Design (CD) and Basic Design (BD) stages plays in streamlining the Commissioning & Qualification (C&Q) process. Emphasizing the incorporation of quality-focused criteria into the User Requirement Specification (URS) through a comprehensive process risk analysis, it underscores the benefits of adopting a “right-first-time” approach. Additionally, it highlights how strategic concepts can be leveraged to achieve time and cost savings while maintaining unwavering compliance. This session is designed for specialists and managers in the pharmaceutical and biotechnology sectors who seek to optimize the C&Q process and lay the groundwork for sustained success.