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Quality by Design (QbD) is a quality concept that deals with a systematic approach to development. It begins with predefined objectives, emphasises product and process understanding, involves process control, and is based on sound science and quality risk management.
QbD works on the principle that quality should be built-in to products deliberately. In order for this to take place a thorough understanding of the product and process by which it is developed and manufactured is required. At all times, there should be absolute clarity on the risks involved in manufacturing the product and how best to mitigate them.
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As a process QbD must be implemented in clear, defined and quantifiable phases. The groundwork for implementing QbD lies in documentation and technical upgradation. Every level of the production process needs to be well-documented. Then, multivariate analysis needs to be applied. For a long time, multivariate analysis was a cumbersome effort due to lack of proper technology. But today, multivariate analysis is possible and desirable as well.
Once the basics are in place, processes such as Design of Experiment (DoE), Failure Modes and Effects Analysis (FMEA), and Process Analytical Technologies (PAT) need to be implemented.
DoE is the design of any information-gathering exercise where variation is present. It is the fundamental process where-in all the variables in the study are identified and segregated into dependent, independent and extraneous variables.
A successful FMEA analysis helps the team to identify potential failure modes based on past experience with similar products or processes. These failures can be designed out of the process, thereby reducing development time and costs.
PAT has been defined by the USFDA as a mechanism to design, analyse, and control pharmaceutical manufacturing processes through the measurement of Critical Process Parameters (CPP) which affect Critical Quality Attributes (CQA).
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QbD gives a higher level of assurance of product quality for patients, and a more efficient regulatory overview and better cost efficiency for the organisation. Of late, the USFDA has been stressing the importance of QbD, and although not compulsory for DMF or ANDA filing, it is still good practice considering the advantages it offers.
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