What is Good Innovation Practices™ (GIP) and how is it different from GMP?

GIP is a forward-looking framework that bridges the gap between early-stage innovation and full GMP compliance. While GMP provides the formal structure for commercial manufacturing, GIP offers agile, risk-based, and phase-appropriate guidance that helps companies scale responsibly without overengineering. It’s designed to embed quality early, enabling speed and compliance from discovery through launch.

When should a company start applying GIP?

Immediately. GIP is most powerful when embedded from the earliest stages of development. Whether you’re setting up your first IND, building your quality team, or planning your clinical manufacturing, GIP provides a scalable structure that grows with your organization—helping you avoid costly missteps and delays later.

How does GIP align with regulatory expectations?

GIP is rooted in global regulatory guidance, including ICH, FDA, and EMA expectations. Agencies increasingly emphasize risk-based, phase-appropriate quality systems, and GIP provides the practical tools to meet those demands. For example, the FDA allows some GMP exemptions in early-phase trials but still expects Quality by Design (QbD) and data integrity. GIP helps organizations interpret and apply these evolving standards without overburdening innovation.

How does GIP support building a strong quality culture?

Quality isn’t just about systems—it’s about people and mindset. GIP promotes a purpose-driven quality culture by encouraging organizations to hire forward-thinking talent, empower decision-making, and embed learning loops across functions. It shifts quality from a compliance checkbox to a shared commitment that unites teams across development, manufacturing, and regulatory.

Whom shall I contact, if I want to learn more?

Contact Dr. Marco Retzlaff directly marco@retzlaffconsulting.com