Quality by Design (QbD) Under supervision of DR:Dalia What is Quality by Design (QbD)? • A Quality System for managing a product’s lifecycle • A regulatory expectation • Intended to increase process and product understanding and thereby decrease patient risk • A multifunctional exercise Principle QbD Concepts • • • • Risk and knowledge based decisions Systematic approaches process development Continuous Improvement This leads to “capable” processes Goal of QbD • Ensures robust commercial manufacturing methods for consistent production of quality drugs. • Ensures the consumers that therapeutic equivalent generics are manufactured every single time. • Offers the agency that quality applications are submitted to improve the review efficiency and to reduce the application approval times. • QbD methodology helps in identifying and justifying target product profiles, product and process understanding. • Helps in continuous improvement. • There is a need for vigorous and well funded research programs to develop new pharmaceutical manufacturing platforms. The pharmaceutical Quality by Design (QbD) • a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. Quality by Design (QbD) is emerging to enhance the assurance of safe, effective drug supply to the consumer, and also offers promise to significantly improve manufacturing quality performance. Critical Quality Attributes (CQA) • chemical, physical, biological and microbiological attributes that can be defined, measured, and continually monitored to ensure final product outputs remain within acceptable quality limits Process analytical technology (PAT) • defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of Critical Process Parameters (CPP) which affect Critical Quality Attributes (CQA). Critical process parameters (CPP) • in pharmaceutical manufacturing are key variables affecting the production process. CPPs are attributes that are monitored to detect deviations in standardized production operations and product output quality or changes in Critical Quality Attributes. THE BENEFITS OF QBD THE BENEFITS OF QBD three main benefits for development: • Reduction of post-approval submissions. • Better innovation due to the ability to improve processes without resubmission to the FDA when remaining in the Design Space. • • • • • • • More efficient technology transfer to manufacturing. Greater regulator confidence of robust products. Risk-based approach and identification. Innovative process validation approaches. Less intense regulatory oversight and less post-approval submissions. For the consumer, greater drug consistency. More drug availability and less recall. QbD activities within FDA • n FDA’s Office of New Drug Quality Assessment (ONDQA), a new risk-based pharmaceutical quality assessment system (PQAS) was established based on the application of product and process understanding. • Implementation of a pilot program to allow manufacturers in the pharmaceutical industry to submit information for a new drug application demonstrating use of QbD principles, product knowledge, and process understanding. In 2006, Merck & Co.’s Januvia became the first product approved based upon such an application. • Implementation of a Question-based Review (QbR) Process has occurred in CDER’s Office of Generic Drugs. • CDER’s Office of Compliance has played an active role in complementing the QbD initiative by optimizing pre-approval inspectional processes to evaluate commercial process feasibility and determining if a state of process control is maintained throughout the lifecycle, in accord with the ICH Q10 lifecycle Quality System. • Implementation of QbD for a Biologic License Application (BLA) is progressing. • For manufacturers, there are potentially huge external costs for delayed product launches or approvals, or severe actions such as consent decrees,” notes one editor of an industry journal, plus “the internal costs of wasted raw materials, scrap batches, and the cost of investigation and remediation.”4 • Imagine the damage to your brand such an event would have. To add further insult, you may have to spend an enormous amount of money just to get your product back to market. • QbD minimizes these risks by mapping all the possible variables of the product attributes and processes into a known control space. This means that if any quality issues occur, your team can use specific methods to quickly pinpoint the scientific variables that are most likely causing the issues. reference https://www.ema.europa.eu/en/documents/presentation/presentation-what-controlcqas-cpps-thomas-stangler-behalfega_en.pdf ?fbclid=IwAR3YMFADdhgcU0iShz24GastS8yhdtx6a566uLERa6QTikWzAnbIidtBS0 https://learnaboutgmp.com/good-validation-practices/pharmaceutical-quality-bydesign-qbd-an-introduction-process-development-and-applications/ https://www.pda.org/docs/default-source/website-documentlibrary/chapters/presentations/australia/quality-by-design-(qbd)overview.pdf ?sfvrsn=6 • • • • • • • Name Ibrahim Fathy Mohamed Mahmoud Zeinab adel Mokhtar Hussein Yasser abdelaal Hamada Ali Mohamed Thabet ID 1131659 1141644 1131228 11610312 11412009 1121076
