AFI QP Meeting 2025

ProductLife Group is actively involved, together with its affiliates LifeBee, C&P Engineering and Pharma D&S, in the AFI QP Meeting (19th and 20th November are the dates for the 2025 edition) – an event that brings together qualified individuals, leaders in the field of quality and compliance, and manufacturing experts to examine what is needed to keep operations traceable, resilient and inspection-ready in a rapidly changing regulatory environment – contributing practical insights derived from daily GMP practice and digital transformation programmes. 

The programme centers on issues that shape day-to-day delivery. Participants focus on GMP updates and regulatory changes that affect the QP role, serialization and supply chain integrity, sustainability in manufacturing and digital quality with responsible use of AI with references to Annex 11 and Annex 22. Real-world case studies from sterile, biologics and shared lines show how to translate guidance into procedures that can be verified and measured. 

Across booth meetings and session breaks, a consistent theme appears: how to sustain a permanent state of inspection readiness. Questions concentrate on document governance, metrics that are meaningful to inspectors and periodic reviews that go beyond compliance and inform decisions. Teams also ask how to integrate digital without losing control. Topics include proportional validation, data integrity by design and change management that stays transparent for Quality, IT and Manufacturing. A third need is coherence between the QMS and the shopfloor, especially in multiproduct or shared-line environments where roles, responsibilities and indicators must align to avoid interruptions and rework. 

ProductLife Group brings practical and measurable support. We help maintain daily GMP compliance and QMS operations, from procedure updates to internal audits and remediation plans that close gaps. We work on validation and data integrity in line with Annex 11 and Part 11, controlling the data lifecycle and its traceability end to end. We stand beside plant teams on systems such as MES, LIMS and eBR, managing IT–OT integration, scalable validations and governed change control. We design digital roadmaps that remain inspectable with prioritised use cases, clear requirements, test evidence and periodic reviews. When needed, we connect sustainability with operational continuity through data quality, serialization and supply chain integrity. 

Conversations on the floor confirm that many companies need support to maintain methodological coherence across countries while adapting documentation to local requirements without losing a common thread. There is growing attention to indicators that measure control effectiveness rather than simple completion. Teams also look for digital evolution plans that move beyond slides and address essentials such as ownership, versioning, evidence and maintenance of control over time. 

The difference between a programme that stays theoretical and a system that withstands inspections lies in execution. This is why we close the loop from initial alignment with QP and QA to the translation of requirements into activities and deliverables, verification of CAPA effectiveness, vendor oversight and periodic reviews that feed continuous improvement. The goal is always the same: quality that supports operations day after day with people, processes and technologies speaking the same language. 

The meeting reinforces what organisations need next. Pragmatic choices, documentation that is essential yet complete, shared methodological structures tailored to local contexts, and a constant focus on traceability and measurable outcomes. Within this frame, PLG and its affiliates provide complementary expertise across Quality, Regulatory, Engineering, CSV and digital transformation to support QPs and Quality leaders in the decisions that matter. 

If you are interested or would like to explore further, contact us