The document provides an overview of quality by design (QbD) in pharmaceutical development. It discusses key QbD concepts like defining a quality target product profile, identifying critical quality attributes and critical material attributes, designing quality into the product through development strategies like design of experiments, and establishing a design space and control strategy. The document outlines the important steps and aspects of a QbD-based pharmaceutical development process from formulation to manufacturing. It emphasizes gaining process understanding, building quality into the product, and taking a systematic risk-based approach.
The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based sound science and quality risk management.
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.
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.
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. A presentation compiled from material freely available on the WEB to introduce the concepts of QbD for beginners.
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.”
According to new syllabus of PCI M.Pharm 1st sem. students can directly utilize this ppt for their study. As per PCI new syllabus QA STUDENTS find this ppt very use full.
Qualification of tablet compression machinePritam Kolge
Qualification of Tablet Compression Machine ...
This topic comes under Quality Control and Quality Assurance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Introduction
#Design Qualification
#Installation Qualification
#Operational Qualification
#Performance Qualification
#Case Study
#Conclusion
#References
Thanks For Help and Guidance of Dr. Mrs. N. M. Bhatia Mam
Quality Risk management in pharmaceutical Industry. A general Review on Risk analysis and Risk assessment in pharmaceutical Industry as it is prescribed by GMP regulations of WHO, ICH, FDA.
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
The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based sound science and quality risk management.
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.
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.
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. A presentation compiled from material freely available on the WEB to introduce the concepts of QbD for beginners.
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.”
According to new syllabus of PCI M.Pharm 1st sem. students can directly utilize this ppt for their study. As per PCI new syllabus QA STUDENTS find this ppt very use full.
Qualification of tablet compression machinePritam Kolge
Qualification of Tablet Compression Machine ...
This topic comes under Quality Control and Quality Assurance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Introduction
#Design Qualification
#Installation Qualification
#Operational Qualification
#Performance Qualification
#Case Study
#Conclusion
#References
Thanks For Help and Guidance of Dr. Mrs. N. M. Bhatia Mam
Quality Risk management in pharmaceutical Industry. A general Review on Risk analysis and Risk assessment in pharmaceutical Industry as it is prescribed by GMP regulations of WHO, ICH, FDA.
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
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.
Thank You , Keep reading and keep sharing.
A presentation covering QbD inclusive of its definition, goals, advantages, QTTP, Risk Assessment Methods, Design of experiment, Life Cycle Management, etc.,
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 Review on Quality by Design and its Approachesijtsrd
The Pharmaceutical Quality By Design QBD is a systematic approach to the development that starts with the predetermined objectives and is based on the process of understanding process processes and process control, sound science and quality risk management. Quality Design QBD has been created to increase the assured of providing safe, effective medicines to customers and promised to make significant improvements in product quality performance. Supriya Khatal | Ashok Bhosale | Tejaswini Kande | Pallavi Dhekale | Punam Bramhadandi | Pratima Pokale "A Review on Quality by Design and its Approaches" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-3 | Issue-6 , October 2019, URL: https://www.ijtsrd.com/papers/ijtsrd29248.pdf Paper URL: https://www.ijtsrd.com/pharmacy/medicinal-chemistry/29248/a-review-on-quality-by-design-and-its-approaches/supriya-khatal
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 by Design is emerging to enhance the assurance of safe, effective drug supply to the consumer, and also offers promise to significantly improve manufacturing quality performance
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
1. QUALITY BY DESIGN IN PHARMACEUTICAL
DEVELOPMENT
Guided by:
S. Rajarajan
Assistant professor
Department of Pharmaceutics
Karnataka college of pharmacy
Presented by:
Mahesh Kumar Mishra
M. Pharm (Pharmaceutics)
2nd Semester
2. CONTENTS
Introduction
QbD in product development
Design space
Important QbD aspects and development flow.
QTTP
DOE
Manufacturing process development.
3. INTRODUCTION
QUALITY
The common element of the business definitions is that the quality of a product or service refers to the
perception of the degree to which the product or service meets the customer’s expectations.
The suitability of a drug product or a drug substance for its intended use. The term includes attributes such as
identity, purity and strength.
4. QUALITY BY DESIGN
A more systematic approach to development can include, for example, incorporation of prior knowledge,
result of studies using design of experiments, use of quality risk management and use of knowledge
management throughout life cycle of the product.
Product quality life cycle is all about the practical means for the implementation of ICH guidance’s on ICH
Q8 (Pharmaceutical Development), Q9 (Quality Risk management) and Q10 (Pharmaceutical Quality
System) based on sound scientific, engineering and business principles.
It is the concept introduced by the ICH-Q8 guidelines, Aa a systemic approach to development that begins
with predefined objectives and emphasizes product, 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.
5.
6. What QbD does in product development
QbD identifies characteristics that are critical to quality from the perspective of patients, translates them
into the attributes that the drug product should possess, and establishes how the critical process parameters
can be varied to consistently produce a drug product with the desired characteristics.to consistently produce
a drug product with the desired characteristics.
For this the relationships between formulation & manufacturing process variables (i.e. CMAs of API and
excipient and CPPs) and product characteristics (QTPP) are established and sources of variability identified
(CQAs).
This knowledge is then used to implement a flexible and robust manufacturing process that can adapt and
produce a consistent product over time.
The increased process knowledge and product understanding resulting from QbD can increase the
efficiency of manufacturing processes; reduce product recalls and compliance actions, resulting in cost
savings for product recalls and compliance actions, resulting in cost savings for pharmaceutical companies.
7. Cont…..
By reducing uncertainty and risk, QbD can allow industry and regulators to focus their resources in the most
critical areas. Because much more process understanding has been demonstrated and expressed in dossier.
QbD filings also can help facilitate GMP inspections by the regulators and decrease the number of post-
approval regulatory submissions required to make process changes.
The QbD-based pharmaceutical manufacturing process will be adjustable within a design space, providing a
robust process that is managed with a control strategy developed using modern process control methods
(DOE) and enabling a lifecycle approach to verification/continuous process verification.
Product specifications will be based on desired product performance characteristics and will be part of a risk-
based quality control strategy.
QbD principles increase product understanding and process knowledge.
8.
9. What is QbD in brief
Pharmaceutical QbD is a systematic, scientific, risk-based, holistic and proactive approach to
pharmaceutical development that begins with predefined objectives and development and emphases
product and processes understanding and process control.
In other words ….
A systematic and knowledge based scientific approach of maintaining CQAs by well defined control
strategy and design space by establishing combination and interaction of CMAs and CPPs to provide
predefined QTPP.
10. What is Design Space ?
It is a multidimensional combination and interaction of input variables (CMAs––critical material
attributes) and process parameters (CPPs––critical process parameters that have been demonstrated to
provide assurance of quality.
Most Important….
Out of Design Space Initiation of Post Approval
11. Important QbD Aspects & Development Flow…
Defining Quality Target Product Profile (QTPP)
Identification of Critical Quality Attributes (CQAs) : Critical/Non Critical.
Identification of Critical Material Attributes (CMAs).
Initial Risk Assessment for Drug Substance Attributes.
Justification for Initial Risk Assessment for Drug Substance Attributes.
Selection of Excipients (Provide Rationale / Justification).
Excipients Compatibility Studies.
Development of Q&Q formula for initial Formulation Development.
Initial Risk Assessment for Formulation Components.
12. Cont…..
Designing Development Strategies.
DOE for Optimization of Formulation.
Defining Design Space for CQAs, CMAs or Formulation Components.
Pilot Bioequivalence Studies.
Update of Initial Risk Assessment for Drug Substance Attributes.
Update of Initial Risk Assessment for Formulation Components.
Justify the Levels of Risks changed.
Well Defined Control Strategy.
13. Cont…..
Development of Manufacturing Process
Initial Risk Assessment for Manufacturing Process
DOE for Optimization of Manufacturing Process
Defining Design Space for identified CQAs or CPPs
Pilot Bioequivalence Study
Justify the Levels of Risks changed
Well Defined Control Strategy
14. Cont…..
Scale-up from Lab to Pilot Scale & then Commercial Scale
Pre-exhibit / Exhibit Batch
Update of Initial Risk Assessment for Manufacturing Process
Pivotal Bioequivalence
Control Strategy for Drug Product
Container Closure System
Development Studies to be supported with Stability Studies
15. Defining Quality Target Product Profile (QTPP)
It contains prospective summary of the desired product features with respect to quality, safety, efficacy.
The QTPP is a product description that summarizes the characteristics expected during the development
to respond to the therapeutic drug target.
QTPP Element Target Justification
Dosage form, Route of
Administration, Strength,
Pharmacokinetics, Stability,
Drug product quality attribute,
Container Closure system, etc.
Product Specific Pharmaceutical equivalent
requirement or specific
16. Identification of Critical Quality Attributes (CQAs)
and defining its criticality
Summarize the CQAs on the basis of quality attributes identified as a target along with the justification for being
CQA
Drug Product CQAs:
Physical Attribute, Assay, Content Uniformity, Drug Release/ Dissolution, Degradation Products, etc.
QA of DP Target Is it CQA? Justification
It should include
product and process
specific quality
attributes
Desired quality Based on impact of
attribute on QTPP
Statement should
clearly justify the
CQA criticality level
scientifically as well
as technically.
17. Identification of Critical Material Attributes
(CMAs)
Physical characterization of Drug Substance
Physical, pH-solubility, Hygroscopisity, MP, Flow, Solid State Form, Polymorphism, etc.
Chemical Characterization of Drug Substance
pH, pKa, Stability, etc.
Biological Characterization of Drug Substance
Partition coefficient, BCS, etc.
--------to identify the CMAs.
18. Initial Risk Assessment for Drug Substance
Attributes
It involves quality risk evaluation in three levels, LOW, MEDIUM, HIGH based on safety and efficacy linked to
scientific knowledge ultimately
Drug Substance Attributes:
Moisture, Hygroscopisity, Solubility, Flow, Chemical Stability, etc.
Drug Product CQAs:
Physical Attribute, Assay, Content Uniformity, Drug Release/ Dissolution, Degradation Products, etc.
Drug Product CQAs Drug Substance Attributes
A B C D
X LOW
Y MEDIUM
Z HIGH
19. Important QbD Aspects & Development Flow…
Selection of Excipients (Provide Rationale / Justification)
Excipients Compatibility Studies
Development of Q&Q formula for initial Formulation Development
20. Formulation Development…..
Designing Development Strategies
Design of Experiments (DoE) for Formulation Development
(This information includes DOE implementation in Product Development by using commercially available
DOE software e.g. Minitab, Design Expert, Stat Graphics, etc.)
DOE should be carried out at, two main stages of Product development
1.To optimize formulation
2.To optimize manufacturing process
21. Design of Experiments (DoE) for Formulation
Development
Why DoE?
To find answers of following common questions,
1.What is an optimum formulation?
2.How does the optimum change if changes are made to formulation or process?
3.Which variables is sensitive to the machine or process?
4.For performance consistency , what are the limits for these variables?
5.How one design can effectively troubleshoot the problem?
To save Time, To Reduce Cost, To get Reliable Quality.
The factors to be studied in a DoE could come from the risk assessment exercise or prior knowledge.
22. Cont…..
DoE to be apply and discuss in brief with respect to Design Steps as follows
1.Screening DoE: Selection of only vital factors from the factors identified in initial risk
assessment.
2. Characterization DoE: Choice of experimental design which gives potential interactions in
selected vital factors.
3.Performance of experiments.
4.Statistical analysis of data.
5.Conclusion along with recommendations if any.
DoE in terms of factors, levels, response variables, design applied, significance and non
significance (p-value)
23. Cont…..
Three basic principles of statistical experimental designs,
1. Randomization
By properly randomizing the experiments, the effects of uncontrollable factors that may be present can be
“averaged out”.
2.Blocking
It is the blocking arrangement of experimental units into groups (blocks) that are similar to one another.
Blocking reduces known but irrelevant sources of variation between groups and thus allows greater precision in
the estimation of the source of variation under study.
3.Replication
It allows the estimation of the pure experimental error for determining whether observe differences in the data
are really statistically different.
24. Design of Experiments (DoE) for Formulation
Development
Factorial Designs – Identify the vital factors that affect your process or product. Then you can make break
through improvements.
Response Surface Methods (RSM) – Find the ideal process settings. Achieve optimal performance.
Mixture design techniques – Discover the optimal formulation.
Combined designs - Combine process variables, mixture components and categoric factors in one design!
25. Manufacturing Process Development
It involves identification of all possible known material attributes and critical process parameters that
could impact the performance of the process.
Initial Risk Assessment for Manufacturing Process:
Risk assessment can be done for each unit operation of manufacturing process steps separately depends
up on the critical considerations for process optimization.
Based on the selected process and CMAs, Initial risk assessment can be done.
(Stage of risk assessment is not fixed. Risk assessment is depends on the criticality of manufacturing process steps.)
26. Initial Risk Assessment for Manufacturing Process
Manufacturing Steps:
Mixing, Granulation, Lubrication, Compression, Coating, etc.
Drug Product CQAs:
Physical Attribute, Assay, Content Uniformity, Drug Release/ Dissolution, Degradation Products, etc.
Drug Product CQAs Manufacturing Process Steps (Each unit operation process step should be
cover)
I J K L
X LOW
Y MEDIUM
Z HIGH
27. CONCLUSION
There is an ever growing need for better understanding of the formulation and process
development by pharmaceutical scientists. Benefits of QbD application for both regulatory
agencies and manufacturers have been proven. It is clear the QbD will become a necessity,
therefore all the stakeholders should adapt to its implementation
