Changes in 🟡 Biopharma Manufacturing Process Lifecycle
- Maturity: 🟡 Provisional
New ontology in this release, review all classes: 🟡 Biopharma Manufacturing Process Lifecycle
Added
Classes
| Construct | Definition |
|---|---|
ContinuedProcessVerificationProcess | planned process performed during routine commercial manufacturing to gain ongoing assurance, through periodic or continuous collection and analysis of product and process data, as to whether a manufacturing process remains in a state of control |
CriticalQualityAttributeIdentificationProcess | planned process that identifies critical quality attributes |
DesignSpace | information content entity that describes a manufacturing process through a multidimensional region of combinations of values of process parameters, input material attributes, or both, within which the process assures product quality |
DrugProductDesignProcess | planned process performed to develop a product that can deliver the desired quality target product profile over its entire shelf life |
EdgeOfFailure | information content entity that describes a manufacturing process through a boundary of values of process parameters, input material attributes, or both, beyond which that process can no longer assure product quality |
ManufacturingFacilityQualificationProcess | planned process performed to assure proper manufacturing facility design and commissioning and demonstrate that associated utilities and equipment perform properly under anticipated commercial operating conditions |
ManufacturingProcessCharacterizationProcess | planned process that systematically develops and documents scientific understanding of how process parameters and material attributes influence quality and performance outcomes |
ManufacturingProcessDesignProcess | planned process that defines and develops the manufacturing steps, process parameters, materials, and control elements of a commercial manufacturing process in order to establish its process design |
ManufacturingProcessPerformanceQualificationProcess | planned process in which a previously qualified facility, utilities, and equipment are used to confirm the process design in order to demonstrate that the commercial manufacturing process performs as expected |
ManufacturingProcessPerformanceQualificationSpecification | plan specification that prescribes a manufacturing process performance qualification process |
ManufacturingProcessQualificationProcess | planned process in which a manufacturing process design is evaluated, through facility design assurance, qualification of utilities and equipment, and process performance qualification, to determine whether it is capable of reproducible commercial manufacture |
PriorKnowledgeInformationContentEntity | information content entity that represents scientifically grounded understanding of a product, material, or process derived from prior experience, technical literature, historical data, and/or established scientific and engineering principles |
ProcessControlStrategyEstablishment | planned process that uses scientific understanding of how process parameters and material attributes influence quality and performance outcomes to create a control strategy |
ProcessModelDevelopment | planned process in which a mathematical or empirical model is developed to represent or predict a manufacturing process or relationships among its process parameters, material attributes, quality attributes, or performance indicators |
ProcessTrendingAnalysis | planned process that systematically analyzes historical and/or current process and quality data to identify patterns, shifts, drifts, or abnormal variability in process parameters, material attributes, quality attributes, or performance indicators within and/or between batches |
QualityTargetProductProfile | requirement specification that represents a prospective summary of the quality characteristics of a product that should ideally be achieved to ensure the desired quality, taking into account the safety and efficacy of that product |
QualityTargetProductProfileDefinition | planned process in which a quality target product profile is established |