GMP Pharma Congress

See you in Germany at the 28th Conference and Expo – Pharma Manufacturing & Technology

Be sure to introduce yourself to Sarah Alimirzaei and Agnes Barti to learn more about how the industry is changing and how to digitalize your system to exceed the new standards.

Event Objective

This conference provides practical insights into the design, construction, qualification, and operation of GMP-compliant pharmaceutical facilities. Participants will learn how to identify typical compliance risks, implement effective clean room and containment concepts, and align GMP and occupational safety requirements. Real-life case studies and expert presentations illustrate how regulatory expectations can be translated into GMP-compliant solutions.

Background

A GMP-compliant pharmaceutical facility provides the structural and organisational framework for manufacturing high-quality medicines. Clean Rooms play a central role by ensuring controlled environments that minimise particulate and microbial contamination. Regulatory authorities define detailed requirements for design, operation and maintenance. Common compliance gaps include inadequate cleaning, insufficient control of personnel and material flows and incomplete documentation.

Many GMP problems originate already during the planning and construction phase. The design must anticipate regulatory expectations, future workflows, and technical interfaces – making project management a critical success factor. Cost, schedule, and GMP compliance must be balanced from concept to commissioning and qualification.

In addition to GMP, occupational safety is equally important in the planning and operation of manufacturing facilities. GMP and occupational safety have become closely linked with the introduction of the PDE/ADE concept, both aiming to prevent the release of active substances. While GMP focuses on avoiding cross contamination, Environment, Health & Safety ensures that employees are not exposed to harmful levels. Effective contamination control strategies therefore address both aspects.

Ensuring clean room and facility compliance requires a coordinated approach across engineering, quality, and production – with inspections and audits placing growing emphasis on risk-based thinking and data integrity.

This conference presents practical examples of how these requirements can be effectively implemented.