CoreVerfahren

CoreVerfahren is a term used in German-speaking industry and academia to denote a framework of core procedures and standardized workflows for process development, optimization, and manufacturing. The term combines “core” with the German “Verfahren” meaning procedure or process, signaling a focus on central methods that recur across projects.

Purpose and scope: CoreVerfahren aims to provide reproducible methods, ensure traceability, and accelerate development cycles. It typically encompasses specification and planning, data collection and management, experimental design, statistical analysis, process modeling, validation, implementation, and comprehensive documentation.

Structure and modules: The framework is modular, with core modules such as design and planning, data handling, quality control and validation, and optional extensions like risk assessment, regulatory compliance, digitalization, and automation.

Applications: It is applied across chemical and pharmaceutical development, materials engineering, and manufacturing industries, particularly in early-phase development, process development, scale-up, and quality management.

Benefits and challenges: Benefits include improved reproducibility, faster decision making, reduced waste, and better regulatory readiness. Challenges include the need for organizational commitment, data governance, and investments in information technology and culture change.

History and adoption: The concept arose from trends toward process standardization and optimization in German-speaking industries during the late 20th and early 21st centuries, and today CoreVerfahren is used as a descriptive label for internal frameworks rather than a single universal standard.

See also: process engineering, standard operating procedure, Good Laboratory Practice, Good Manufacturing Practice, design of experiments.