Recently, Mr. Ralf Gengenbach, Founder & CEO of Gempex Consulting and Chairman of the ECA (European Compliance Academy) Validation Group, chaired and participated in the ECA Annual Forum held in Germany.

The forum brought together senior experts from official drug regulatory inspectors (e.g., from Germany, Sweden, Austria) and leading global pharmaceutical companies such as Roche and B. Braun to discuss the latest regulatory trends and technical strategies in the field of pharmaceutical compliance.

Judging from the topics of this forum, the industry's focus is deepening from "meeting basic regulatory requirements" to "pursuing efficiency, resilience, and intelligence of the quality system." Gempex Consulting brings the following interpretations of four major new compliance trends from the scene.

1. Knowledge Management: Increasingly Becoming a Focus of Official Inspections

   Dr. Rainer Gnibl, a GMP Inspector from Bavaria, Germany, elaborated on "Knowledge Management" at the forum, pointing out its fundamental role within the ICH Q10 quality system.

   Gempex Insight: Regulators are transforming knowledge management from a theoretical requirement into practical operation. Inspectors are paying increasing attention during actual inspections to how companies manage knowledge and systematically assess how they collect, manage, and apply knowledge assets. Companies should establish systematic knowledge management mechanisms to ensure that everything from process data and deviation investigations to validation experience can be effectively captured and reused, in order to respond to increasingly in-depth inspection inquiries.

2. Deep Integration of GEP and GMP: The Key to Solving Project Delays and Budget Overruns

   The alignment of GEP (Good Engineering Practice) and GMP, a perennial topic, remains a major pain point leading to significant project delays and budget overruns. Mr. Ralf Gengenbach of Gempex Consulting shared on-site how to use mature tools in projects to manage and control GEP & GMP work, helping companies achieve both compliance and efficiency.

   Gempex Insight: We are currently assisting clients with projects involving budget overruns at the multi-million euro level, most of which stem from engineering and qualification not being advanced in parallel from the conceptual stage of the project. Future compliance solutions must involve "designing in" GMP compliance from the earliest project stages, rather than "adding it on" afterwards.

3. Streamlined VMP and the "Pixi Booklet": Validation Documentation Moves Towards Lightweight and Visual Formats

   This year's forum showcased two innovative documentation practices:

   • B. Braun's One-Page VMP Concept: Essentially a linked document, it condenses the core elements of the Validation Master Plan onto a single-page view, linking all individual documents. Users can quickly locate key information based on this one-page VMP, balancing compliance completeness with operational efficiency.

     
     Streamlined VMP

     
     

   • ECA's "Pixi Booklet" Illustrated Guides: Transform complex core validation principles into illustrated booklets, helping frontline personnel quickly understand key concepts and operational points. Like comics, they turn complex concepts into clear and easy-to-understand manuals. ECA has currently produced booklets on CARA and URS topics.

     
     Existing ECA Pixi Booklets: CARA (Critical Aspect Risk Assessment) & URS (User Requirement Specification)

     
     

   Gempex Insight: This is not merely a simplification of form but an upgrade in philosophy. In the future, documentation tools that can efficiently communicate compliance intent will become a key differentiator for a company's quality execution capability.

   Note: The Pixi Booklet was originally designed as a very small, highly illustrated booklet for children. The intent here is to facilitate rapid and simple knowledge acquisition through this communication format.

4. "Fleet Management": Providing a Compliance Pathway for Scalable Production Expansion

   The "Fleet Management" model shared by Roche, which involves the standardized replication of validated production lines, achieved approximately 15% cost savings and a 33% reduction in FAT time for subsequent production lines.

   Gempex Insight: This model provides clear direction for Chinese pharmaceutical companies facing rapid production expansion or global layout. Although the benefits of this model are significant under ideal conditions, practical challenges such as equipment variations and regional regulations remain during implementation. Its success highly depends on the systematization of upfront design and the precision of later replication, representing a comprehensive embodiment of engineering and quality capabilities.

Conclusion: Continuously Introducing Global Cutting-Edge Compliance Practices to China

Through continuous and in-depth participation in international industry forums like the ECA, Gempex Consulting ensures that our services remain synchronized with the latest global regulatory thinking and industry best practices.

"The significance of participating in these forums lies not only in acquiring information but also in contributing to the formation of industry consensus," Ralf summarized. "This enables us to always stay at the forefront of compliance practices, providing clients with solutions that combine an international perspective with practical implementation capabilities."

In the future, Gempex Consulting will continue to serve as a bridge connecting Chinese and global pharmaceutical compliance practices, assisting companies in advancing steadily while balancing quality and efficiency.

If you wish to learn more about GMP solutions, you can visit www.gempexchina.com/gmp-knowledge. There, you will gain a deeper understanding of Gempex Consulting's GMP services.

If you have specific compliance challenges, please contact us via the following methods.

Hotline: 400 166 2002
Email: info-cn@gempex.com

About gempex China

gempex China has been deeply involved in the GMP compliance field for 23 years, committed to providing compliant, efficient, and executable GMP solutions for global life sciences companies. We help various parties in pharmaceuticals, biotechnology, APIs, chemicals, medical devices, excipients/packaging materials, and cosmetics meet GMP standards and reduce compliance and drug safety risks.

Currently, we have over 60 experienced GMP experts, have cumulatively executed over 5,000 projects globally, provided professional services to more than 1,000 clients, operate in over 20 countries, and have established long-term cooperative relationships with numerous renowned pharmaceutical companies.