Annex 1 and the Shift to Proactive Sterile Manufacturing

Ever since the revised Annex 1 was published, drug makers have been navigating a broader transformation of sterile manufacturing that extends beyond compliance. Contamination control, in turn, is becoming a more proactive, data-driven, and highly collaborative model, one that emphasizes continuous improvement, global alignment, and deeper integration across the supply chain. While the regulation itself builds on decades of precedent, its latest iteration is accelerating expectations around risk management, documentation, and end-to-end control strategies.

In this episode of Off Script, we spoke with Haley Johnson, senior manager of product management, and Bill Matakas, vice president of business transformation at West Pharmaceutical Services, about how Annex 1 is reshaping sterile manufacturing operations and supplier relationships. The conversation explores the industry’s shift from reactive remediation to proactive risk prevention, the growing importance of contamination control strategies as living systems, and how inspectors are increasingly focused on measurable, year-over-year improvement.