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Definition
| A planned set of controls, derived from current product and process understanding, which ensures process performance and product quality. The controls can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control. |
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| The multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality. Working within the design space is not considered a change. Movement out of the design space is considered a change and would normally initiate a regulatory post-approval change process. Design space is proposed by the applicant and is subject to regulatory assessment and approval. |
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| Drug Product - The dosage form in the final immediate packaging intended for marketing |
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| The material which is subsequently formulated with excipients to produce the drug product. It can be composed of the desired product, product-related substances, and product- and process-related impurities. It may also contain excipients including other components such as buffers |
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| Formal Experimental Design (aka DOE) |
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Definition
| A structure, organized method for determining the relationship between factors affecting a process and the output of that process |
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| Good Engineering Practices - Those established engineering methods and standards that are applied throughout the lifecycle to deliver appropriate and cost-effective solution |
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| Process Intermediate (aka In-Process Material) |
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Definition
| A material produced during the steps of the processing of an API and undergo further molecular change or purification before it becomes and API. Intermediates may or may not be isolated. |
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| All phases in the life of a product, from the initial development throughout marketing until the product's discontinuation. |
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| Normal Operating Range - A defined range, within (or equal to) the Proven Acceptable Range, specified in the manufacturing instructions as the target and range at which a process parameter is controlled, while producing unit operation material or final product meeting release criteria and CQAs |
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Definition
| Critical Process Parameter - A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality |
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| Key Process Parameter - An input process parameter that should be carefully controlled within a narrow range and is essential for process performance. A key process parameter does not affect product quality attributes If the acceptable range is exceeded, it may affect the process (e.g., yield, duration) but not product quality. |
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Definition
| An input parameter that has been demonstrated to be easily controlled or has a wide acceptable limit. Non-key operational parameters may have an impact on quality or process performance if acceptable limits are exceeded. |
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Definition
| Critical Material Attribute - ??? |
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Definition
| Process Parameter - an input variable or condition of the manufacturing process that can be directly controlled in the process. Typically, these parameters are physical or chemical (e.g., temperature, process time, column flow rate, column wash volume, reagent concentration, buffer pH, etc) |
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Definition
| Development of a production strategy for a new drug starting from manufacturing processes similar to those used to manufacture other drugs of the same type, the production for which exists considerable experience) |
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Definition
| Process Analytical Technology - A system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-porcess materials and processes with the goal of ensuring final product quality. |
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Definition
| Process Performance Qualification - The second element of the Process Qualification. It includes a combination of the actual facility, utilities, equipment, and the trained personnel with the commercial manufacturing process, control procedures, and components to produce commercial batches. A successful PPQ will confirm the process design and demonstrate that the commercial manufacturing process performs as expected. Batches prepared are also called Conformance batches or PPQ batches. |
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| Process Qualification - Confirming that the manufacturing process, as designed, is capable of reproducible commercial manufacturing. |
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| Ability of a process to tolerate variability of materials and changes of the process and equipment without negative impact on quality. |
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Definition
| The collection and evaluation of data from the process design stage to commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality products. |
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| Process Validation Master Plan - A document that defines the process validation scope and rationale and that contains the list of process validation studies to be performed. |
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Definition
| Proven Acceptable Range - A characterized range of a process parameter for which operation within this range, while keeping other parameters constant, will result in producing a material meeting relevant quality criteria |
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| Quality by Design - A systematic approach tot he development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. |
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| The suitability of either a drug substance or drug product for its intended use. This term includes such attributes as the identity, strength, and purity. |
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| Quality Target Product Profile - A prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking in to account safety and efficacy of the drug product |
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Definition
| Target Product Profile - A format for a summary of a drug development program described in terms of labeling concepts to facilitate communication regarding a particular drug development program. |
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Definition
| A systematic approach to verify that manufacturing systems, acting alone or in combination, are fit for intended use, have been properly installed, and are operating correctly. This is an umbrella term that encompasses types of approaches to ensure the systems are fit for such as qualification, commissioning and qualification, verification, system validation, or other. |
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Definition
| A set of conditions encompassing upper and lower processing limits and circumstances, including those within standard operating procedures, that pose the greatest hanse of process or product failure (when compared to ideal conditions). Such conditions do not necessarily induce product or process failure. |
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Term
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| Failure Mode Effects Analysis - |
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| Elements of Stage 1a - PD |
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Definition
Stage I - Process Development
1) Establish TPP and QTPP
2) Identify CQAs
3) Define the process |
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Term
| Elements of Stage 1b - PC |
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Definition
Stage I - Process Characterization
1) Perform Quality Risk Assessment; Initial Categorization of Parameters
2) Perform Process Characterization Experiments
3) Final categorization of parameters based on criticality and establish control strategy
{Scale-up, tech transfer, and design space establishment may occur during 2 & 3} |
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Term
| Elements of Stage II - CPQ |
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Definition
Commercial Process Qualification
1) Implement Process Control Strategy
2) Qualify Facilities, Utilities, and Equipment
3) Qualify Process Peformance |
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Term
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Definition
| CPV - Continued Process Verification |
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| Specifications (IP & Release) |
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Definition
| IP and product specifications may be related to product safety and efficacy or may assure product consistency. Confirmed failure to meet a product specification disqualifies material from clinical or commercial use. See ICH Q6a/Q6b. |
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Definition
| IPCs are inputs to the process and are checks performed during production to monitor and, if appropriate, adjust the process, and/or to ensure that the intermediates or product conform to specifications or other defined quality criteria. |
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Term
Performance Parameters
(NTBCW 'process parameters) |
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Definition
| Performance parameters are process outputs that cannot be directly controlled but are indicators that the process has performed as expected. |
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Term
| Process parameter set points and ranges |
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Definition
| Knowledge of the effects of process parameter variability on the output of each Unit Operation and on the final product evolves during Process Development and Process Characterization. This information, along with process equipment capability, is used to establish parameter set points and ranges (including ranges for alarms and deviations). It may also be sued to assess the severity of precess deviations caused by parameter excursions. Parameter ranges may be designated as normal operating ranges, or where proven by supportive data, as proven acceptable ranges. |
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Term
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Definition
| Data review, sampling, and testing - Process monitoring includes measurement data (e.g., flow rates, temperatures, volumes, pH), in-process sampling plans, and appropriate analytical assays. Data collection and analysis begins in Stage 1 and are integral parts of Stage 2, Process Performance Qualification. The data collection effort eventually evolves into the continues process monitoring program described for Stage 3, Continued Process Verification. |
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Definition
| Hold conditions and times are an essential part of the process control strategy for all process intermediates (or IP materials), DS, bulk DP, and prepared solutions. Studies should be performed to support these limits. Time limits for processing steps should also be part of the control strategy. |
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