INTRODUCTION TO QUALITY BY DESIGN (QBD)
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Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding based on sound science. The main objectives of QbD are to ensure quality products by combining prior knowledge with new data to identify critical quality attributes and critical process parameters, and establish a control strategy within a design space. This approach helps provide a better understanding of processes and fewer batch failures through improved control and management of changes over the product lifecycle.
![1] The Target Product Quality Profile (TPQP) -
TPQP has been defined as a “prospective
and dynamic summary of the quality
characteristics of a drug product that ideally
will be achieved to ensure that the desired
quality, and thus the safety and efficacy, of a
drug product is realized”.
11](https://image.slidesharecdn.com/qbdchetanpawar-180730090242/85/INTRODUCTION-TO-QUALITY-BY-DESIGN-QBD-11-320.jpg)
![13
2] Critical Quality Attribute (CQA) -
Once TPQP has been identified, the next step is
to identify the relevant CQAs.
A CQA has been defined as “a physical, chemical,
biological, or microbiological property or
characteristic that should be within an
appropriate limit, range, or distributed to ensure
the desired product quality”
Prior product knowledge, such as the
accumulated laboratory, nonclinical and clinical
experience with a specific product-quality
attribute, is the key in making these risk
assessments](https://image.slidesharecdn.com/qbdchetanpawar-180730090242/85/INTRODUCTION-TO-QUALITY-BY-DESIGN-QBD-13-320.jpg)
![3] Critical Process Parameter (CPPs) -
Critical process parameters (CPPs) are defined
as “parameters whose variability have an
impact on a CQA and therefore should be
monitored or controlled to ensure the
process produces the desired quality”
Process robustness is defined as the ability of
a process to demonstrate acceptable quality
and performance and tolerate variability in
inputs at the same time.
14](https://image.slidesharecdn.com/qbdchetanpawar-180730090242/85/INTRODUCTION-TO-QUALITY-BY-DESIGN-QBD-14-320.jpg)
![4] Risk Assessment -
Quality risk management is a systematic
process for the assessment, control,
communication and review of risks to the
quality of the drug (medicinal) product across
the product lifecycle.
The initial list of potential parameters which
can affect CQAs can be quite extensive but
can be reduced by quality risk assessment
(QRA).
15](https://image.slidesharecdn.com/qbdchetanpawar-180730090242/85/INTRODUCTION-TO-QUALITY-BY-DESIGN-QBD-15-320.jpg)
![16
5] Design Space –
The ICH Q8(R2) States that the design space
is multi dimensional 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 .](https://image.slidesharecdn.com/qbdchetanpawar-180730090242/85/INTRODUCTION-TO-QUALITY-BY-DESIGN-QBD-16-320.jpg)
![6] Control Strategy-
Control strategy is defined as “a planned set of
controls, derived from current product and process
understanding that assures process performance and
product quality”.
The ability to evaluate and ensure the quality of in-
process and/or final product based on process data
which typically include a valid combination of
measured material attributes and process controls.
ICH Q8(R2).
The control strategy can include the following
elements: procedural controls, in process controls, lot
release testing, process monitoring, characterization
testing, comparability testing and stability testing .
17](https://image.slidesharecdn.com/qbdchetanpawar-180730090242/85/INTRODUCTION-TO-QUALITY-BY-DESIGN-QBD-17-320.jpg)
![7] Life Cycle Management
In the QBD paradigm, process changes within
the design space will not require review or
approval.
Therefore, process improvements during the
product life cycle with regard to process
consistency and throughput could take place
with fewer post approval submissions.
18](https://image.slidesharecdn.com/qbdchetanpawar-180730090242/85/INTRODUCTION-TO-QUALITY-BY-DESIGN-QBD-18-320.jpg)
INTRODUCTION TO QUALITY BY DESIGN (QBD)
- 1. Presented By- Chetan Vishwanath Pawar M. Pharmacy Sem – II Guided By- Mrs. S. MUTHA Department of Pharmaceutics PDEA’s S.G.R.S. College of Pharmacy Saswad. Subject – Formulation & Development 1
- 2. Introduction Concepts and Background of QBD Advantages of QBD Objectives of QBD Key Aspects of QBD Significance of QBD Conclusion Reference 2
- 3. QULITY – “Quality can not be tested into products; it has to be built in by design” 3
- 4. DEFINATION OF QBD - ‘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’ 4
- 5. Quality by Design is a concept first outlined by Joseph M. Juran in various publications. He supposed that quality could be planned. The concept of QBD was mention in ICH Q8 guidelines, which states that, “To identify quality can not be tested in products, i.e. Quality should be built in to product by design.” 5
- 6. Benefits for Industry: Better understanding of the process. Less batch failure. More efficient and effective control of change. Return on investment / cost savings. 6
- 7. 7 Additional opportunities: Reduction of post-approval submissions. More efficient technology transfer to manufacturing. Risk-based approach and identification. Innovative process validation approaches.
- 8. The main objectives of QBD is to ensure the quality products, for that product & process characteristics important to desired performance must be resulting from a combination of prior knowledge & new estimation during development. From this knowledge & data process measurement & desired attributes may be constructed. Ensures combination of product & process knowledge gained during development. 8
- 9. Q8- Pharmaceutical Development Q9- Quality Risk Management Q10- Pharmaceutical Quality System Q11- Development and Manufacture of Drug Substances 9
- 10. 10
- 11. 1] The Target Product Quality Profile (TPQP) - TPQP has been defined as a “prospective and dynamic summary of the quality characteristics of a drug product that ideally will be achieved to ensure that the desired quality, and thus the safety and efficacy, of a drug product is realized”. 11
- 12. TPP forms the basis for product design in the following way Dosage form Route of administration Strength Release Pharmacological characteristic Drug product quality criteria Pharmaceutical elegance 12
- 13. 13 2] Critical Quality Attribute (CQA) - Once TPQP has been identified, the next step is to identify the relevant CQAs. A CQA has been defined as “a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distributed to ensure the desired product quality” Prior product knowledge, such as the accumulated laboratory, nonclinical and clinical experience with a specific product-quality attribute, is the key in making these risk assessments
- 14. 3] Critical Process Parameter (CPPs) - Critical process parameters (CPPs) are defined as “parameters whose variability have an impact on a CQA and therefore should be monitored or controlled to ensure the process produces the desired quality” Process robustness is defined as the ability of a process to demonstrate acceptable quality and performance and tolerate variability in inputs at the same time. 14
- 15. 4] Risk Assessment - Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle. The initial list of potential parameters which can affect CQAs can be quite extensive but can be reduced by quality risk assessment (QRA). 15
- 16. 16 5] Design Space – The ICH Q8(R2) States that the design space is multi dimensional 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 .
- 17. 6] Control Strategy- Control strategy is defined as “a planned set of controls, derived from current product and process understanding that assures process performance and product quality”. The ability to evaluate and ensure the quality of in- process and/or final product based on process data which typically include a valid combination of measured material attributes and process controls. ICH Q8(R2). The control strategy can include the following elements: procedural controls, in process controls, lot release testing, process monitoring, characterization testing, comparability testing and stability testing . 17
- 18. 7] Life Cycle Management In the QBD paradigm, process changes within the design space will not require review or approval. Therefore, process improvements during the product life cycle with regard to process consistency and throughput could take place with fewer post approval submissions. 18
- 19. 19
- 20. 20 Quality by Design means –designing and developing formulations and manufacturing processes to ensure a predefined quality . Quality by Design requires – understanding how formulation and manufacturing process variables influence product quality . Quality by Design ensures – Product quality with effective control strategy.
- 21. QbD is the effective tool, should be implement from the initial stage of the product development independent of target market . Discuss QbD scheme with other groups and stake holder to achieve aim of QbD and keep future projection to avoid regulatory queries and post approval changes/Variation . DoE is not mandatory for QbD based submission. 21
- 22. INTERNATIONAL JOURNAL OF PURE & APPLIED BIOSCIENCE Quality by Design (QBD) Approach used in Development of Pharmaceuticals Jyotsna Balasaheb Jadhav1 , Nitin Namdeo Girawale and Rakesh Ashok Chaudhari . ISSN: 2320 – 7051 Int. J. Pure App. Bio sci. 2 (5): 214-223 (2014) Research and Reviews: Journal of Pharmaceutical Quality Assurance Quality by Design Sushila D. Chavan*, Nayana V. Pimpodkar, Amruta S. Kadam, Puja S.Gaikwad . WHO Prequalification Programme : Priority Essential Medicines Quality by Design (QbD) and Pharmaceutical Active Ingredient Maufacture 22
- 23. ICH Guideline Q8 – Pharmaceutical Development, http://www.ich.org (10 Nov 2005). U.S. Food and Drug Administration Guidance for Industry. PAT – A Framework for Innovative J.C. Berridge An Update on ICH Guideline Q8 – Pharmaceutical Development, www.fda.gov/ohrms/dockets/AC/06/ slides/2006- 4241s1_2.ppt, ISPE Vienna Congress 2006. 23
- 24. 24