QbD ppt.pptx

QbD can be applied to the development and evaluation of analytical methods. During
method development, all potential factors (the inputs) and all critical analytical
responses (the outputs) are studied to determine the relationships. Critical analytical
factors are identified in an approach that parallels what is described for process
development in ICH Q8 and Q9. A corporate knowledge repository is required
throughout the process to ensure critical information is captured that can be reviewed
and added to in the future such that lessons learned can be applied to the specific
methods under consideration and also to other similar methods being applied to other
products. s

1. Quality by Design Prepared by : Noman Khan M.Pharm [ 2 nd Sem ] Moradabad Educational Trust, Group of Institutions, Faculty of Pharmacy , Moradabad - 244001

2. Definition of Quality by Design Q bD describes a pharmaceutical development approach referring to formulation design and development and manufacturing processes to maintain the prescribed product quality.

3. Q8 Guidelines of ICH A ccording to the Q8 guidelines for quality driven development, “a systematic approach to development that begins with predefined objectives and emphasize product, process understanding, and process control, based on sound science ”.

4. Key characteristics of QbD A tool for focused & efficient drug development Dynamic and systematic process Relies on the concept that Quality can be built in as a continuum It is applicable to Drug Product and Drug Substance development (chemicals / biologics) It is applicable to analytical methods Can implemented partially or totally Can be used at any time in the life cycle of the Drug Always encouraged by Regulators.

5. Benefits of QBD QbD is good Business Eliminate batch failures Minimize deviations and costly investigations Avoid regulatory compliance problems Organizational learning is an investment in the future QbD is good Science Better development decisions Empowerment of technical staff

6. Opportunities Efficient, agile, flexible system Increase manufacturing efficiency and reduce costs Build scientific knowledge base for all products Better interact with industry on science issues Ensure consistent information Incorporate risk management

7. Quality Target Product Profile (QTTP) QTTP is “Prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the drug product”.

8. Critical quality attributes (CQAs) “ A physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality”

9. Quality risk management (QRM) The FDA defines a Risk Management as, a strategic safety program designed to decrease product risk by using one or more interventions or tools. It is systematic process for the assessment, control, communication and review of risks to the quality of the drug product across the product lifecycle

10. Design space ICH Q8(R2) defines design space as “ 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 as a change. Movement out of the design space is considered to be 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.”

11. Challenges Though Quality by design is an essential part of the modern approach to pharmaceutical quality, but Lack of understanding regarding the pharmaceutical process is the cause and also the major limitation for QbD implementation

12. Thank You