🟡 Biopharma Manufacturing Process Lifecycle
Maturity: 🟡 Provisional
IRI: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaManufacturingProcessLifecycle/
RDF: BiopharmaManufacturingProcessLifecycle.rdf
The Biopharma Manufacturing Process Lifecycle Ontology provides constructs for representing how biopharmaceutical manufacturing processes are designed, characterized, qualified, validated, and monitored over time. It supports the representation of lifecycle activities that connect product quality expectations, critical quality attributes, process understanding, risk assessment, control strategy development, facility and equipment qualification, process performance qualification, and continued process verification. The module is intended to provide a consistent way to describe how scientific and engineering knowledge about a biopharmaceutical process is generated, used to establish the commercial process, and maintained through ongoing manufacturing and lifecycle management.
Annotations
Copyright
Copyright (c) 2022, 2023, 2024, 2025, 2026 Open Applications Group
License
http://opensource.org/licenses/MIT
Classes (17)
| Class | Definition |
|---|---|
| continued process verification process | planned process performed during routine commercial manufacturing to gain ongoing assurance, through periodic or continuous collec… |
| critical quality attribute identification process | planned process that identifies critical quality attributes |
| design space | information content entity that describes a manufacturing process through a multidimensional region of combinations of values of p… |
| drug product design process | planned process performed to develop a product that can deliver the desired quality target product profile over its entire shelf l… |
| edge of failure | information content entity that describes a manufacturing process through a boundary of values of process parameters, input materi… |
| manufacturing facility qualification process | planned process performed to assure proper manufacturing facility design and commissioning and demonstrate that associated utiliti… |
| manufacturing process characterization process | planned process that systematically develops and documents scientific understanding of how process parameters and material attribu… |
| manufacturing process design process | planned process that defines and develops the manufacturing steps, process parameters, materials, and control elements of a commer… |
| manufacturing process performance qualification process | planned process in which a previously qualified facility, utilities, and equipment are used to confirm the process design in order… |
| manufacturing process performance qualification specification | plan specification that prescribes a manufacturing process performance qualification process |
| manufacturing process qualification process | planned process in which a manufacturing process design is evaluated, through facility design assurance, qualification of utilitie… |
| prior knowledge information content entity | information content entity that represents scientifically grounded understanding of a product, material, or process derived from p… |
| process control strategy establishment | planned process that uses scientific understanding of how process parameters and material attributes influence quality and perform… |
| process model development | planned process in which a mathematical or empirical model is developed to represent or predict a manufacturing process or relatio… |
| process trending analysis | planned process that systematically analyzes historical and/or current process and quality data to identify patterns, shifts, drif… |
| quality target product profile | requirement specification that represents a prospective summary of the quality characteristics of a product that should ideally be… |
| quality target product profile definition | planned process in which a quality target product profile is established |
Table of contents
- 🟧 continued process verification process
- 🟧 critical quality attribute identification process
- 🟧 design space
- 🟧 drug product design process
- 🟧 edge of failure
- 🟧 manufacturing facility qualification process
- 🟧 manufacturing process characterization process
- 🟧 manufacturing process design process
- 🟧 manufacturing process performance qualification process
- 🟧 manufacturing process performance qualification specification
- 🟧 manufacturing process qualification process
- 🟧 prior knowledge information content entity
- 🟧 process control strategy establishment
- 🟧 process model development
- 🟧 process trending analysis
- 🟧 quality target product profile
- 🟧 quality target product profile definition