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Top Quality
Quality by design (qbd)
QUALITY BY DESIGN (QbD)
K.S.Rathore*, Deepika Pokhrana, Sadhana Yadav
B.N.Girls' College of Pharmacy, Udaipur-Raj.
Quality by design(QbD)
QbD is design decisions based on through formulation and process understanding as these relate to the intended use. Quality by design means designing and developing a product and associated manufacturing processes that will be used during product development to ensure that the product consistently attains a predefined quality at the end of the manufacturing process. QbD can be achieved in a structured manner guided by scientific information/knowledge gathered during pre-formulation, development, scale-up, and in production
Area of quality by design
Quality by design implementation targets the following departments within a pharmaceutical company- Management, Procurement, R&D, Manufacturing, Testing, Quality control, Quality assurance, Regulatory, Logistics, Sales, Warehouse/ Supply chain including vendors' facilities, CRO and CMO.
Principles of quality by design
QbD scope assume that problems can be anticipated and their occurrence prevented by reviewing data and analyzing risks associated with operational and quality system processes and by keeping abreast of changes in scientific developments and regulatory requirements. The central goal of a quality system is the consistent production of safe and effective products and ensuring that these activities are sustainable. A robust quality system will promote process consistency by integrating effective knowledge-building mechanisms into daily operational decisions. When fully developed and effectively managed, a QbD system will lead to consistent, predictable processes that ensure that pharmaceuticals are safe, effective, and available for the consumer.
Framework of quality by design
Quality by design integrates quality systems and risk management approaches into its existing programs with the goal of providing the necessary framework for implementing quality by design (building in quality from the development phase and throughout a product's life cycle), continual improvement and risk management in the drug manufacturing process and also for post development changes and optimization.
Quality risk management (governed by CAPA- corrective actions preventive actions) is a valuable component of an effective quality systems framework. Quality risk management can, for example, help guide the setting of specifications and process parameters for drug manufacturing, assess and mitigate the risk of changing a process or specification, and determine the extent of discrepancy investigations and corrective actions.
CAPA focuses on investigating, understanding, and correcting discrepancies while attempting to prevent their recurrence. QbD system models discuss CAPA as three separate concepts, all of which are used in this guidance:
- Remedial corrections of an identified problem.
- Root cause analysis with corrective action to help understand the cause of the deviation and potentially prevent recurrence of a similar problem.
- Preventive action to avert recurrence of a similar potential problem.
Review outcomes typically include:
• Improvements to the quality system and related quality processes.
• Improvements to manufacturing processes and products.
• Realignment of resources.
The results of a management review would typically be recorded. Planned actions should be implemented using effective CAPA and change control procedures.
The FDA's emphasis on drug applications that include Quality by Design (QbD) data has sparked a surge in activity for protein therapeutics R&D teams. The overarching goal of Quality by Design is to improve biological therapeutics safety and efficacy, while additional benefits include increasing the efficiency of manufacturing process, which reduces cost, and the potential for faster regulatory approval of new drugs.
The FDA has stated that "Quality by Design means that product and process performance characteristics are scientifically designed to meet specific objectives, not merely empirically derived from performance of test batches." As a direct consequence, one of the core tenets of QbD is the requirement of detailed knowledge of the critical quality attributes (CQAs) of the biological product and the critical process parameters (CPPs) that can be used to control overall product quality. Gathering the raw data needed for this endeavor can be prohibitively time, labor, and cost intensive without employing Design of Experiment (DOE) approaches, also known as Factorial Experimental Design (FED). Even with DOE, a significant number of samples need to be processed, which has created a need for next generation Process Analytical Technologies that provide robust, high throughput, predictive results for critical quality attributes such as titer, purity, aggregation, fragmentation, and size. Quality by Design (QbD) is a concept first outlined by well-known quality expert Joseph M. Juran in various publications, most notably Juran on Quality by Design. Juran believed that quality could be planned, and that most quality crises and problems relate to the way in which quality was planned in the first place.
While Quality by Design principles have been used to advance product and process quality in every industry, and particularly the automotive industry, they have most recently been adopted by the U.S. Food and Drug Administration (FDA) as a vehicle for the transformation of how drugs are discovered, developed, and commercially manufactured.
Pharmaceutical quality by design
This FDA imperative is best outlined in its report "Pharmaceutical Quality for the 21st Century: A Risk-Based Approach." In the past few years, the Agency has made significant progress in implementing the concepts of "Quality by Design" (QbD) into its processes. The focus of this concept is that quality should be built into a product with a thorough understanding of the product and process by which it is developed and manufactured along with a knowledge of the risks involved in manufacturing the product and how best to mitigate those risks. This is a successor to the "quality by QC inspection" (or "quality after design") approach that the FDA has taken until the late 1990s / early 2000s.
QbD activities within FDA
Specifically, the following activities are guiding the overall implementation of QbD:
- In 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 monitoring post-approval state of process control under the ICH Q10 lifecycle Quality System.
- Implementation of QbD for a Biologic License Application (BLA) is progressing.
Regulatory benefits of QbD
– Product and process specifications are based on a mechanistic understanding of how formulation and process factors affect product performance
– Risk-based regulatory approaches recognize
- the level of scientific understanding of how formulation and manufacturing process factors affect product quality and performance and
- the capability of process control strategies to prevent or mitigate the risk of producing a poor quality product
– Example: Customized Scale-up and post approval changes [SUPAC –C]
About the Author
Reader, Bhupal Nobles' Girls' College of Pharmacy, Udaipur-Raj.313002 INDIA Email: kamalsrathore@yahoo.com kamalsrathore@gmail.com Mobile: +919828325713
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