Uploaded by ibrahim elkassas

Quality by Design

Quality by Design
Under supervision of
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
• 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.
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
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
• 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.
https://www.ema.europa.eu/en/documents/presentation/presentation-what-controlcqas-cpps-thomas-stangler-behalfega_en.pdf ?fbclid=IwAR3YMFADdhgcU0iShz24GastS8yhdtx6a566uLERa6QTikWzAnbIidtBS0
https://www.pda.org/docs/default-source/website-documentlibrary/chapters/presentations/australia/quality-by-design-(qbd)overview.pdf ?sfvrsn=6
Ibrahim Fathy
Mohamed Mahmoud
Zeinab adel
Mokhtar Hussein
Yasser abdelaal
Hamada Ali
Mohamed Thabet