CPhI 2026 in Milan: Where the Operational Side of Pharma Stands

CPhI Worldwide is the largest annual trade fair for the global pharmaceutical industry. More than 60,000 professional visitors from over 150 countries come together to discuss active ingredients, excipients, production technology and services across the entire pharmaceutical value chain. In 2026 the fair took place from 6 to 8 October in Milan (Fiera Milano). It stands for the operational breadth of the industry, not for research topics.

Entourage was on site with a team. From our perspective, three themes shape the operational agenda of the industry.

Annex 1: Between the Obligation to Implement and Room for Interpretation

The revised EU GMP Annex 1 was published on 25 August 2022 and has applied to manufacturers of sterile medicinal products since 25 August 2023, point 8.123 since 25 August 2024. Even so, Annex 1 implementation remains a permanent topic: many companies meet the technical requirements but have not yet set up their documented evidence and the PUPSIT assessment (Pre-Use Post-Sterilization Integrity Test) in a way that holds up to inspection.

The real work lies in interpretation, not in technical feasibility. Which contamination sources must the Contamination Control Strategy Document (CCSD) address? How detailed does the risk analysis for qualifying a cleanroom zone have to be? The standard leaves room, and authorities make use of that room during inspections.

AI in Manufacturing: Between Pilot and GMP Readiness

Artificial intelligence is omnipresent as a topic but rarely a validated reality in the GMP environment. The discussions revolve around AI in quality control (automated image analysis, predictive analytics in the laboratory) and in process optimization. A clear answer is regularly missing to the question of how AI systems are validated in an environment subject to CSV.

EU GMP Annex 11 governs computerised systems, but its application to self-learning or AI-based components is not yet conclusively regulated. A company that wants to use AI in production or quality control today is operating in a gray area that calls for a pragmatic, risk-based approach.

Supply Chain Resilience: From Crisis Topic to Management Task

The supply shortages of recent years raised structural questions that were not answered when the shortages ended. Supply chain resilience has moved from a crisis topic to a permanent strategic management task: diversification of sources of supply, near-shoring of critical active ingredients and geopolitical risk assessment now belong in every production strategy.

The challenge: measures such as dual sourcing considerably increase the complexity of qualification. A second supplier means a second qualification process and a second change control chain. The supply chain decision and its regulatory feasibility have to be thought through together.

After the Show

In practice these three themes do not run separately but in parallel, and they draw on the same resources in quality and regulatory affairs. None of them ended with the last day of the fair. Entourage's hybrid approach combines both: strategic planning and operational execution from a single source.

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