Navigating Digitalization, QRM Maturity, and Global Compliance Convergence into 2026

PharmTech connected recently with Henrik Johanning, senior vice president, Quality & Strategy, Epista Life Science, to look back at 2025 and ahead into 2026. Johanning details major European regulatory and manufacturing trends transitioning from 2025 into 2026, focusing on the operationalization of modern quality risk management (QRM) and tangible upgrades required for facilities to achieve sustained compliance with European Union (EU) good manufacturing practice (GMP) Annex 1. The conversation explores the rising expectations for digital Good Manufacturing Practice (GMP) driven by Annex 11 and Annex 22, the reconfiguration of supply chains due to geopolitical factors, and the ongoing convergence of global standards under International Council for Harmonisation (ICH), Pharmaceutical Inspection Co-operation Scheme (PIC/S), and EU GMP.

PharmTech: What trends are shaping the transition from 2025 into 2026?

Johanning: From a European regulatory and manufacturing perspective, several converging trends stand out:

• Operationalization of modern QRM following ICH Q9. Companies are moving from theoretical risk assessments toward genuinely risk-based prioritization of controls, remediation, and capital investment.
• EU GMP Annex 1 implementation maturity. Many sterile facilities are discovering that procedural compliance is insufficient; sustained compliance requires tangible upgrades to contamination control strategies, facility design, and utilities, particularly water and HVAC-systems.
• Rising expectations around digital GMP, driven by EU GMP Annex 11 and Annex 22.
  • Annex 11 is driving stronger expectations around lifecycle management of computerized systems, data integrity, supplier oversight, and continued validation in increasingly complex and cloud-based IT architectures.
  • Annex 22 reinforces that digital tools, automation, and data used across development and manufacturing must be governed under the pharmaceutical quality system, with clear roles, accountability, and traceability from development into commercial production.
• Supply chain and network reconfiguration is accelerating as manufacturers respond to geo-political uncertainty, rising tariffs, and single-source dependencies. We see increased focus on regionalization, dual sourcing, and closer alignment between manufacturing footprint decisions and global regulatory convergence under EU GMP, ICH, and PIC/S.
• Continued convergence across EU GMP, ICH, and PIC/S, resulting in less tolerance for regional interpretation gaps, particularly during inspections of global manufacturing and supply networks.

What trends do you see in AI and digital technology?

AI and advanced analytics are already improving efficiency in such areas as process monitoring, deviation handling, and documentation.

The main barriers to broader adoption are regulatory and organizational rather than technical (Figure): non-GMP-ready data, uncertainty around how to validate and govern AI/ML within Annex 11 expectations, and a shortage of hybrid profiles combining quality, engineering, and data expertise.

What trends do you see in pharmaceutical professional skills and talent?

Digitalization is widening the gap between traditional GMP roles and newer automation- and data-driven roles.

Leading organizations are investing in structured upskilling linked to concrete initiatives (e.g., manufacturing execution systems, continued process verification, digital quality management systems), developing hybrid quality, engineering, and data profiles, and using clearer career pathways as a retention lever.

What trends do you see in facilities, competitiveness, and sustainability?

Margin pressure, patent cliffs, and pricing reforms are forcing tighter alignment between network strategy, quality risk, and capital expenditure decisions. Sustainability is increasingly shaping facility and process design, especially HVAC, water systems, and cleaning strategies, where environmental performance, operational robustness, and cost efficiency are beginning to converge into the same business case.

What should pharma manufacturers plan for in 2026?

Manufacturers should prepare for regulatory-driven digitalization under Annex 11 and Annex 22, continued modernization of legacy sterile and biotech facilities, and a shift from isolated IT or engineering projects toward integrated people, process, technology programs, with QRM, data integrity, lifecycle governance, and supply chain resilience built in from the outset.