The term "EBR-compliant recipe creation" refers to the process of developing production recipes that meet the requirements of an Electronic Batch Record (EBR) system. This digital method of recipe creation enables standardized, efficient, and regulatory-compliant documentation of production processes in the pharmaceutical, biotechnology, and food industries.
Dynamic recipe design: Creation and adaptation of recipes from predefined building blocks
Digital publication: Automatic publication of recipes in the EBR system
Validation support: Integrated verification mechanisms to ensure recipe conformity
Version control: Management of different recipe versions with change tracking
Parameter definition: Specification of critical process parameters and limits
Workflow integration: Incorporation of release and approval processes
Compliance checking: Automatic verification of regulatory requirements compliance
Creation of a master batch record for a new pharmaceutical product
Adaptation of an existing recipe for a new batch size
Digitization of a paper-based manufacturing protocol
Integration of standard operating procedures (SOPs) into a digital recipe
Creation of recipe variants for different product families
Implementation of in-process controls in a digital manufacturing recipe