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A QTPP relates to the quality of a drug substance or the drugs products that is necessary to deliver a desired therapeutic effect. QTPP is a predetermined summary of the characteristics of the drug product that will ideally be essential to ensure the desired quality with respect to safety and efficacy of the product.
These predetermined QTPP evolve over time during drug development and may be modified to incorporate new knowledge, as is warranted by ongoing clinical studies such a dose effect and toxicology data.
Critical quality attributes CQA. Critical quality attributes are defined as physical, chemical, biological or microbiological properties or characteristics that need to be controlled to ensure product quality.
According to ICH Q8 CQAs as physical, chemical, biological or microbiological properties or characteristics that should be within an appropriate limit, range, or distribution to ensure the desired product quality. Thus CQA is used to describe both aspects of product performance and determinants of product performance.
Risk assessment16, 17, 18 A key objective of risk assessment in pharmaceutical development is to identify which material attributes and process parameters affect the drug product CQAs, that is, to understand and predict sources of variability in the manufacturing process so that an appropriate control strategy can be implemented to ensure that the CQAs are within the desired requirements.
The identification of critical process parameters CPP and critical material attributes is an iterative process and occurs throughout development. The risk assessment tools used in earlier phases of development therefore tend to be more qualitative and serve as a means to prioritize the experimentation.
Design space ICH Q8 defines design space as, the multidimensional combination and interaction of input variables material attributes and process parameters that have been demonstrated to provide assurance of quality.
Moving out of the design space is considered to be a change and would normally initiate a regulatory post-approval change process. The design space is proposed by the applicant and is subject to regulatory assessment and approval.
Design space is potentially scale and equipment dependent, the design space determined on the laboratory scale may not be relevant to the process at the commercial scale.
Therefore, design-space verification at the commercial scale becomes essential unless it is confirmed that the design space is scale-independent. Currently, generic drug sponsors obtain information about acceptable ranges for individual CPPs and CMAs at laboratory or pilot scales.
Multidimensional combination of and interaction of input variables and process parameters that have been demonstrated to provide Quality Assurance Fig. Design space17 Control Strategy19, 20 A planned set of controls, derived from current product and process understanding that ensures process performance and product quality….
Life cycle Management and Continuous improvement After approval, CQAs are monitored to ensure that the process is performing within the defined acceptable variability that served as the basis for the filed process design space.
The primary benefit of an expanded process design space would be a more flexible approach by regulatory agencies.
In the QbD paradigm, process changes within the design space will not require review or approval. Therefore, process improvements during the product life cycle with regard to process consistency and throughput could take place with fewer post approval submissions.
In addition to regulatory flexibility, the enhanced understanding of the manufacturing process would allow more informed risk assessment as per ICH Q9 regarding the affects of process changes and manufacturing deviations on product quality.
Manufacturing, the experience grows and opportunities for process improvement identified are operating space could be revised within the design space without the need for post-approval submission.
Over the lifetime of a product, process changes may be required to be made and may require process characterization, validation and filing of the changes to the approved process design space. The quality system needs to provide adequate oversight during QbD implementation of changes that will not go through regulatory approval.
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