GMP Annex 1 Implementation

Giovanni Cosmi, Pharmaceutical Quality Systems Senior Consultant, Mirko Gabriele, Pharmaceutical and Innovation Consultant, and Andrea Salmaso, Regulatory and Scientific Affairs Manager

Sterile manufacturing continues to be one of the most dynamic and strategically important areas in the pharmaceutical industry. The COVID-19 pandemic underscored just how critical a resilient and well-managed sterile supply chain is to preventing drug shortages and maintaining patient access. In response, pharmaceutical companies have sharpened their focus on strengthening this infrastructure, while regulatory bodies have elevated its integrity as a top priority. This heightened attention is not just reactive it aligns with a broader trend: sterile-manufactured drug products are projected to remain the fastest-growing segment in the industry. With a strong compound annual growth rate expected over the next several years, the sector is poised for sustained expansion. For organizations operating in or adjacent to this space, understanding the evolving demands and expectations around sterile manufacturing is essential.

Delve into the full asset to gain deeper insights into the drivers of growth and the strategies shaping the future of sterile production.