This is the seminar on Quality By Design (QbD) .
In this will discuss about Concept , Objectives, Benefits, Key Aspects of QbD.
Specially Design for a Seminar type Presentation.
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Model dependent approach for drug release testing of controlled drug deliveryNehaFernandes2
A controlled drug delivery system is the one which delivers the drug at a predetermined rate, locally or systemically, for a specified period of time. Drug release is an important property of a therapeutic system, constituting a pre-requisite to absorption of the therapeutic agent and one that contributes to the rate and extent of active availability to the body. Hence while formulating such dosage forms one important factor that has to be taken into consideration is the release kinetics.
To provide particular, predetermined release profiles, it is necessary to know the exact mass transport mechanisms involved in drug release, and to predict quantitatively the resulting drug release kinetics. This is when the mathematical equations come into picture.
Mathematical equations describe the dependence of release in function of time. The use of this tool is very beneficial to predict the release kinetics before the release systems are comprehended. This analytical solution comprises of several models that have been used to design a number of simple and complex drug delivery systems and devices and to predict the overall release behavior. By achieving such a goal, the development process can be accelerated and innovative products can be introduced more rapidly than if such predictions are unavailable.
Application of a wide-range bioavailability model facilitates screening of potential drug candidates for controlled release, optimizing formulation design, and interpreting bioavailability data.
M.pharm (Pharmaceutics) Modern Pharmaceutics unit- Validation Part-1 introduction, scope and merits of validation, Validation and calibration of Master plan, ICH & WHO guidelines for calibration and validation of equipment.
QBD Quality by design for Immediate release dosage formKushal Saha
Traditional approach of formulating a new drug product is an exhaustive task and involves a number of resources like man, money, time and experimental efforts. While, using this Quality by Design (QBD) approach one can get the pharmaceutical product of desired (best) quality with minimizing above resources as well as knowing the influence of one factor over the desired associated process. Hence aim of this study is the understanding of QBD approach to design product and manufacturing process to get desired pharmaceutical product. QBD follows the concepts of ICH guidelines (Q8, Q9 & Q10) which are essential for processing a pharmaceutical process. In this presentation we are going to focus upon QBD for immediate release dosage forms.
This presentation includes introduction of validation, types of validation,process validation of dosage forms[ solids(tablets),liquids(emulsions and suspensions),semisolids.
Model dependent approach for drug release testing of controlled drug deliveryNehaFernandes2
A controlled drug delivery system is the one which delivers the drug at a predetermined rate, locally or systemically, for a specified period of time. Drug release is an important property of a therapeutic system, constituting a pre-requisite to absorption of the therapeutic agent and one that contributes to the rate and extent of active availability to the body. Hence while formulating such dosage forms one important factor that has to be taken into consideration is the release kinetics.
To provide particular, predetermined release profiles, it is necessary to know the exact mass transport mechanisms involved in drug release, and to predict quantitatively the resulting drug release kinetics. This is when the mathematical equations come into picture.
Mathematical equations describe the dependence of release in function of time. The use of this tool is very beneficial to predict the release kinetics before the release systems are comprehended. This analytical solution comprises of several models that have been used to design a number of simple and complex drug delivery systems and devices and to predict the overall release behavior. By achieving such a goal, the development process can be accelerated and innovative products can be introduced more rapidly than if such predictions are unavailable.
Application of a wide-range bioavailability model facilitates screening of potential drug candidates for controlled release, optimizing formulation design, and interpreting bioavailability data.
M.pharm (Pharmaceutics) Modern Pharmaceutics unit- Validation Part-1 introduction, scope and merits of validation, Validation and calibration of Master plan, ICH & WHO guidelines for calibration and validation of equipment.
QBD Quality by design for Immediate release dosage formKushal Saha
Traditional approach of formulating a new drug product is an exhaustive task and involves a number of resources like man, money, time and experimental efforts. While, using this Quality by Design (QBD) approach one can get the pharmaceutical product of desired (best) quality with minimizing above resources as well as knowing the influence of one factor over the desired associated process. Hence aim of this study is the understanding of QBD approach to design product and manufacturing process to get desired pharmaceutical product. QBD follows the concepts of ICH guidelines (Q8, Q9 & Q10) which are essential for processing a pharmaceutical process. In this presentation we are going to focus upon QBD for immediate release dosage forms.
This presentation includes introduction of validation, types of validation,process validation of dosage forms[ solids(tablets),liquids(emulsions and suspensions),semisolids.
Objectives , policies and principles of cGMP guidelines in pharmaceutical ind...JaskiranKaur72
The presentation contains detailed information about the current GMP in the pharmaceutical industry. It has objectives , policies and principles of cGMP guidelines.
Pdf file is being attached in the link below- https://drive.google.com/file/d/11al8n8AqrkUR_Vnm-z4Mp6O0elzyniEz/view?usp=drivesdk
Objectives and policies of c gmp, layout of building and servicesSharwari Sapate
Pharmaceutical Quality affects every individual. Therefore GMP is required to ensure the quality of the particular drug or dosage form. In this presentation you will go through some basic information about cGMP and layout of buildings.
The release of the drug substance from the drug product leading to the bioavailability of the drug substance. The assessment of drug product performance is imp. Since bioavailability is related both to the pharmacodynamic responses and the adverse events. The performance tests relate the quality of a drug product to clinical safety and efficacy.
Bioavailability studies are drug product performance studies used to define
the effect of changes in the physicochemical properties of the drug substance, the formulation of the drug, and the manufacturing process of the drug product.
Pharmaceutical Validation, its scope and types. Validation Team. validation Master plan. Validation protocols. Elements of Validation. Approaches of Validation. Dosage form Validation along with example of Validation of Tablet Dosage form.
Qbd is a technique of planing a safeguard for the formulation from the process of starting material to the final product , its main aim is to built the quality in the product not to testing.
Objectives , policies and principles of cGMP guidelines in pharmaceutical ind...JaskiranKaur72
The presentation contains detailed information about the current GMP in the pharmaceutical industry. It has objectives , policies and principles of cGMP guidelines.
Pdf file is being attached in the link below- https://drive.google.com/file/d/11al8n8AqrkUR_Vnm-z4Mp6O0elzyniEz/view?usp=drivesdk
Objectives and policies of c gmp, layout of building and servicesSharwari Sapate
Pharmaceutical Quality affects every individual. Therefore GMP is required to ensure the quality of the particular drug or dosage form. In this presentation you will go through some basic information about cGMP and layout of buildings.
The release of the drug substance from the drug product leading to the bioavailability of the drug substance. The assessment of drug product performance is imp. Since bioavailability is related both to the pharmacodynamic responses and the adverse events. The performance tests relate the quality of a drug product to clinical safety and efficacy.
Bioavailability studies are drug product performance studies used to define
the effect of changes in the physicochemical properties of the drug substance, the formulation of the drug, and the manufacturing process of the drug product.
Pharmaceutical Validation, its scope and types. Validation Team. validation Master plan. Validation protocols. Elements of Validation. Approaches of Validation. Dosage form Validation along with example of Validation of Tablet Dosage form.
Qbd is a technique of planing a safeguard for the formulation from the process of starting material to the final product , its main aim is to built the quality in the product not to testing.
The Pharmaceutical Quality by Design is 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 cannot be tested into products; it has to be built in by design.
DEFINITION,PRINCIPLE, OBJECTIVES, ELEMENTS AND TOOLS OF QUALITY BY DESIGN (Qb...Durgadevi Ganesan
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.”
What is Quality by Design (QbD)?
Quality by Design (QbD) is a strategic approach employed in various industries, including pharmaceuticals, manufacturing, and product development, to ensure the consistent delivery of high-quality products.
Why QbD?
Principle of QbD
Objectives of QbD
ELEMENTS OF PHARMACEUTICAL QUALITY BY DESIGN:
- Quality Target Product Profile
- Critical Quality Attributes
- Product Design and Understanding
- Process Design and Understanding
- Process Design and Understanding
- Design space
- Control Strategy
- Continual Improvement
DESIGN TOOLS
- Prior Knowledge
- Risk Assessment
- Mechanistic Model, Design of Experiments, and Data Analysis
- Process Analytical Technology
QbD is new concept in pharmaceutical industries which is beneficial for producing and maintaining quality in product. With help of QbD a quality is built in product during manufacturing.
A presentation covering QbD inclusive of its definition, goals, advantages, QTTP, Risk Assessment Methods, Design of experiment, Life Cycle Management, etc.,
Pharmaceutical Quality by Design (QBD) is a concept introduced by the International Conference on Harmonization (ICH) Q8 guideline, as a systematic approach to development that begins with predetermined objectives and emphasizes the understanding of production and processes and process control, based on sound science and quality risk management.
The basic concept of QBD is “The Quality cannot be tested into the product, but it should be built into it.”
Welcome to our Slideshare presentation on the Qualification of Autoclave, an essential process to ensure the effective sterilization of medical instruments and equipment. In this presentation, we will explore the significance of autoclave qualification, its various stages, and the critical factors involved in maintaining sterilization safety.
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Welcome to our presentation on hazards, with a specific focus on mechanical and electrical hazards.
Our primary goal is to raise awareness about the potential risks associated with these hazards and provide practical solutions to ensure a safer working environment.
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Topic 4: Preventive Measures You can read and makes notes
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Details ppt on Effluent Treatment Plant or ETP for M Pharm.
In this Presentation we discuss about defination , design , need , Mechanism and many more important things related to ETP.
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Qualification of Friability Test Apparatus.pptxGNIPST
Brief description of qualification of laboratory testing apparatus : Friability Test Apparatus.
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2. CONTENT
Introduction
Concepts and Background of QbD
Advantages of QbD
Objectives of QbD
Key Aspects of QbD
Conclusion
Reference
3. Quality:
Modern definition of quality derives from Juran's "fitness for intended use." This definition basically
says that quality is "meeting or exceeding customer expectations."
"Quality can not be tested into products; it has to be built in by design"
Definition of QbD :
Quality by Design (QbD) is a strategic process for development and manufacturing. It is meant to
ensure that the intended performance of a final drug product is as expected.
Introduction
Concepts Of QbD :
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."
4. Advantages of QbD
1. Benefits for Industry:
2. Better understanding of the process.
3. Less batch failure.
4. More efficient and effective control of change.
5. Return on investment / cost savings.
Additional opportunities:
1. Reduction of post-approval submissions.
2. More efficient technology transfer to manufacturing.
3. Risk-based approach and identification.
5. Objectives of QBD:
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 development.
From this knowledge and data process measurement and desired attributes may be
constructed.
Ensures combination of product and process knowledge gained during development.
To increase product development and manufacturing efficiencies
6. Boards of health like the Food and Drug Administration and ICH guidelines Q8,
Q9 and Q10, provide a framework for Quality by Design (QbD).
ICH Guideline • Primarily ICH Q8 through Q10
Q8- Pharmaceutical Development
Q9- Quality Risk Management
Q10- Pharmaceutical Quality System
8. 1. QTPP
QTPP is a prospective summary of the quality characteristics of a drug product that help to achieved the desired
quality with safety and efficacy of the drug product.
QTPP forms the basis of design for the development of the product.
QTPP include the following :
Intended use in a clinical setting, route of administration, dosage form, and delivery system(s).
Container closure systems.
Therapeutic moiety release or delivery which affecting pharmacokinetic characteristic.
Drug product quality criteria (e.g., sterility, purity, stability, and drug release).
QTPP forms the basis for product design in the following way:
i. Dosage form
ii. Route of administration
iii. Strength
iv. Release
v. Pharmacological characteristic
vi. Drug product quality criteria
9. 2. Critical Quality Attributes
Identification of the CQAs of the drug product is the next step in drug product development. A CQA
is a physical, chemical, biological, or microbiological property of an output material including
finished drug product that should be within an appropriate limit, range, or distribution to ensure the
desired product quality .
The quality attributes of a drug product may include identity, assay, content uniformity, degradation
products, residual solvents, drug release or dissolution, microbial limits, and physical properties such
as color, shape, size, odor, and friability.
2.1 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"
10. 3. 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 .
11. 4. 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
The relationship between the process inputs (material attributes and process
parameters) and the critical quality attributes can be described in the design
space.
12. 5. Control Strategy
Control Strategy is
Planned set of controls
Derived from current product and process understanding that assures process
performance and product quality.
It should include starting materials, intermediates, and finished products.
The elements of the control which contribute to the final product quality include
In-process controls,
The controls of input materials (drug substance and excipients),
Intermediates (in-process materials),
Container closure system.
13. CONCLUSION
QbD is the effective tool, should be implement from the initial
stage of the product development independent of target market
.
The goals of implementing QbD in pharmaceutical to reduce
product variability and defects, thereby enhancing product
development and manufacturing efficiencies.
14. 1. INTERNATIONAL JOURNAL OF PURE & APPLIED BIOSCIENCE Quality by
Design (QBD) Approach used in Development of Pharmaceuticals byJyotsna
Balasaheb Jadhavl , Nitin Namdeo Girawale and Rakesh Ashok Chaudhari .
2. Research and Reviews: Journal of Pharmaceutical Quality Assurance Quality by
Design Sushila D. Chavan*, Nayana V. Pimpodkar, Amruta S. Kadam, Puja
S.Gaikwad .
3. WHO Prequalification Programme Priority Essential Medicines Quality by Design
(QbD).
4. ICH Guideline Q8 - Pharmaceutical Development, http://www.ich.org (1 0 Nov
2005).
5. Understanding Pharmaceutical Quality by Design from :National Library of
Medicine.
REFERENCES