Total quality management (TQM) and quality by design (QbD) are important approaches for maintaining quality in the pharmaceutical industry. TQM focuses on continuous improvement and prevention of defects rather than detection. It involves strategic commitment, employee involvement, and precise techniques. QbD is a systematic approach that includes prior product and process understanding to design quality into the manufacturing process from the beginning. The main objectives of QbD are increasing efficiency, enhancing product quality, and avoiding regulatory issues. It involves defining quality target profiles, identifying critical quality attributes, assessing risks, and establishing control strategies.
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.
The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.
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.
The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.
Presentation complied by Drug Regulations – a not for profit organization from publicly available material form FDA , EMA, EDQM . WHO and similar organizations.
Visit www.drugregulations.org for the latest in Pharmaceutic
Technology Transfer in Pharma Industry, Technology Transfer in Pharmaceutical Industry, Pharmaceutical Technology Transfer, Pharma Tech Transfer, Naseeb basha, Pharmaceutical Tech Transfer, Naseeb basha Technology Transfer in Pharma Industry, Naseeb basha Pharmaceutical Technology Transfer
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.
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
Pilot plant Techniques and Product consideration for liquid dosage forms.D.R. Chandravanshi
CONTENTS:-
DEFINITION
INTRODUCTION
OBJECTIVES
LIQUID DOSAGE FORM
STEPS INVOLVED IN PILOT PLANT FOR ORAL LIQUID
GENERAL CONSIDERATION
Reporting responsibility
Personal requirements
Space requirements
Review of formula
Raw materials
Relevant processing equipments
Process evaluation
GMP consideration
Assurance
PILOT PLANT SCALE UP FOR SUSPENSION
PILOT PLANT SCALE UP FOR EMULSION
REFERENCES
Quality management systems - INDUSTRIAL PHARMACY llJafarali Masi
syllabus
Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP
Presentation complied by Drug Regulations – a not for profit organization from publicly available material form FDA , EMA, EDQM . WHO and similar organizations.
Visit www.drugregulations.org for the latest in Pharmaceutic
Technology Transfer in Pharma Industry, Technology Transfer in Pharmaceutical Industry, Pharmaceutical Technology Transfer, Pharma Tech Transfer, Naseeb basha, Pharmaceutical Tech Transfer, Naseeb basha Technology Transfer in Pharma Industry, Naseeb basha Pharmaceutical Technology Transfer
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.
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
Pilot plant Techniques and Product consideration for liquid dosage forms.D.R. Chandravanshi
CONTENTS:-
DEFINITION
INTRODUCTION
OBJECTIVES
LIQUID DOSAGE FORM
STEPS INVOLVED IN PILOT PLANT FOR ORAL LIQUID
GENERAL CONSIDERATION
Reporting responsibility
Personal requirements
Space requirements
Review of formula
Raw materials
Relevant processing equipments
Process evaluation
GMP consideration
Assurance
PILOT PLANT SCALE UP FOR SUSPENSION
PILOT PLANT SCALE UP FOR EMULSION
REFERENCES
Quality management systems - INDUSTRIAL PHARMACY llJafarali Masi
syllabus
Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP
Quality Management System including the Quality management and certificationAshwiniRaikar1
Concept of Quality, Total Quality Management, Quality by Design, Six Sigma concept, Out of Specification, Change control, Introduction to ISO 9000 Series of quality system standards, ISO 14000,NABL, GLP
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
Quality concepts in pharmaceutical industry
ICH guidelines and Total quality management
Quality by design and six sigma concepts
ISO standards and series
Good laboratory practice
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.
A presentation covering QbD inclusive of its definition, goals, advantages, QTTP, Risk Assessment Methods, Design of experiment, Life Cycle Management, etc.,
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 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.
Similar to quality management systems: Total quality management & Quality by design (20)
Nonlinear Pharmacokinetics
-Tests to detect nonlinearity in pharmacokinetics
-CAUSES OF NONLINEARITY
-MICHAELIS MENTEN EQUATION
-Estimation of Km and V max
-Km and V max from Steady State Concentration
Multiple Dosage Regimens
1. Define the index for measuring drug accumulation.
2. Define drug accumulation and drug accumulation t1/2
3. Explain the principle of superposition and its assumptions in multiple dose regimens.
4. Describe Repetitive Intravenous injections One Compartment Open Model
5. Describe Repetitive Extravascular dosing One Compartment Open model
6. Describe Multiple Dose Regimen Two Compartment Open Model
Non compartmental pharmacokinetics & physiologic pharmacokinetic models by aktDr Ajay Kumar Tiwari
Non Compartmental Analysis
-Assumptions to be made
-Statistical Moment Theory
-Mean Residence Time
-Mean Transit Time (MTT), Mean Absorption Time (MAT), and Mean Dissolution Time (MDT)
-Other Pharmacokinetic Parameters
-Advantages and Disadvantages of Noncompartmental Versus Compartmental Population Analyses
Physiologic Pharmacokinetic Models
-Physiologically based pharmacokinetic (PBPK) modeling
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-advantages & disadvantage
MULTICOMPARTMENT MODELS
TWO COMPARTMENT OPEN MODEL
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-method of residuals
-Urinary excretion data
-Loo Riegelman method
One-compartment open model
1.One compartment open model intravenous bolus administration.
2.One compartment open model continuous intravenous infusion .
3.One compartment open model extravascular zero order absorption .
4.One compartment open model extravascular first order absorption
1.Definition and introduction to Pharmacokinetics.
2.Basic considerations in Pharmacokinetics.
3.Pharmacokinetic models.
4.Compartment models.
5.Pharmacokinetics parameters
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
Introduction to Change Control.
Definition of Change Control.
Function of Change Control.
Area of Change.
Written Procedures and Documentation.
Qms NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES (...Dr Ajay Kumar Tiwari
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
1. Introduction to NABL
2. NABL and ISO Principles
3. Need of NABL
4. Recognition of NABL in International Level
5. Scope of NABL
6. Advantages of NABL
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
Introduction to OOS
Identification of OOS: Reports of Laboratory Investigation
Responsibility of Analyst and Supervisor
Identification of OOS:
Reports of Full Scale Investigation
Review of Manufacturing, Production and Sampling
Review of Lab Investigation Result
Supplementary Laboratory Testing Procedure
Analysis of Investigated Results
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
Si x sigma concepts.
Aim of 6 sigma concepts.
Process of 6 sigma concepts.
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
ISO Quality Standards
1. Quality Management System (QMS)
2. ISO Quality Standards
3. ISO 9000
4. ISO 9000 Series
5. Requirements of ISO 9000 Series
6. Advantages of ISO Certification
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
ISO Quality Standards
1. Introduction to ISO 14000
2. Principle of ISO 14000
3. Features of ISO 14000
4. Advantages of ISO 14000
5. ISO 14000 Series
6. Process of ISO 14001 Certification
7. Environmental Management System (EMS)
8. Features of EMS
Quality management systems: Good Laboratory Practice (QMS GLP)Dr Ajay Kumar Tiwari
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
1. Introduction to GLP
2. Definition of GLP
3. Fundamentals of GLP
4. GLP Principles
5. Aim of GLP
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
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Palestine last event orientationfvgnh .pptxRaedMohamed3
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2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
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Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
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This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
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Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
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TQM
Pharmaceutical industry is key part of the health care system.
Regulation of this industry is very important,
because one mistake in production or design can cause more severe
condition in relation to health care system.
So, the Maintenance of the quality of the drugs is so important in
pharmaceutical industries,
because the poor quality of drugs can cause health hazards and economical
burden for both the government and patients.
6. TREY
research
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TQM
Total quality management is improvised in the industries
to maintain the quality and safety of the drugs and prevention of the defects
rather than the detection.
The pharmaceutical quality system is described under ICH guideline Q10.
The concepts, key points of quality improvement of TQM were proposed by
several eminents like
Edward Deming, Joseph Juran, Philip Crosby, Genichi Taguchi, etc.
7. TREY
research
“A management approach of an organization
centered on quality,
based on participation of all its members and
aiming at long term benefits to all members of
the organization and society”.
[International Organization of Standard (ISO)]
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TQM
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TQM: Focus
Key components:
1. Consumer/Customer focus
2. Involvement of employee
3. Continuous improvement
TQM is controlled by customer focus,
process (planning, management and
improvement) and total participations.
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research
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TQM: Focus
The key ingredients of TQM are:
1. Strategic commitment by the management
2. Employee involvement
3. Materials used in the organizations
4. Precise techniques used by the organizations and
5. Improved methods
(Mazumder et al, 2011)
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research
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TQM: Statistical Quality
Control
To achieve accuracy, statistics play an important role in
quality management systems.
Seven major tools used for statistical process control are:
1. Histogram
2. Pareto chart
3. Cause and effect diagram (Fish bone diagram)
4. Defect concentration diagram.
5. Control chart
6. Scatter diagram
7. Check sheet
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research
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TQM: Statistical Quality
Control
1. Histogram
A histogram is an accurate representation of the distribution of numerical data (related with one
variable).
2. Pareto chart
A Pareto chart is a type of chart that contains both bars and a line graph, where individual values
are represented in descending order by bars, and the cumulative total is represented by the line.
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research
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TQM: Statistical Quality
Control
3. Cause and effect diagram (Fish bone diagram)
It helps to identify the possible causes of a specific problem or quality characteristic.
4. Defect concentration diagram
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research
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TQM: Statistical Quality
Control
3. Cause and effect diagram (Fish bone diagram)
It helps to identify the possible causes of a specific problem or quality characteristic.
4. Defect concentration diagram
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research
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TQM: Statistical Quality
Control
5. Control chart
The control chart is a graph used to study how a process changes over time. Data are
plotted in time order.
A control chart always has a central line for the average, an upper line for the upper
control limit and a lower line for the lower control limit.
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research
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TQM: Statistical Quality
Control
6. Scatter diagram
The scatter diagram graphs pairs of numerical data, with one variable on each axis, to
look for a relationship between them. If the variables are correlated, the points will
fall along a line or curve.
7. Check sheet
The check sheet is a form or document used to collect data in real time at the location
where the data is generated.
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research
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TQM
Advantages
1. Improve in quality and safety of the drugs.
2. Improvement of customer satisfaction.
3. Improvement of reputation of industry.
4. Total involvement of employee with higher
moral and responsibilities.
5. Lower economic burden.
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research
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QbD
Pharmaceutical industries always rely on the continuous
improvement in safety, quality and efficacy of the products.
The pharmaceutical products are intended for the patient care.
So, the priority is enhanced therapeutic benefits and absence of
impurities.
Therefore, the product should be designed to meet patients’
needs and the intended product performance.
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research
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QbD
The product quality and performance are regulated by
finished product testing, with understanding of the process
and critical process parameters.
The US FDA (Food and Drug Administration) has adopted the
principles of QbD in the development, manufacturing and
regulation of pharmaceutical products.
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QbD
ICH guidelines also focus on the principles of QbD
through its guidelines mentioned as
ICH Q8 (R2)- Pharmaceutical Development,
ICH Q9 (Quality Risk Management),
ICH Q10 (Pharmaceutical Quality System) and
ICH Q11 (Development and manufacture of drug
substances).
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QbD
According to US FDA and ICH Q8 (R2)
QbD is a systematic approach
to development which includes
the prior knowledge of product and process
understanding
based on the results of studies
using design of experiments,
use of quality risk management and
use of knowledge management.
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QbD: Objectives
Main objectives:
1. Increasing manufacturing efficiency.
2. Increasing the efficiency in product development.
3. Enhancement of product quality and performances to meet
patients’ needs.
4. Increase in process capability.
5. Avoidance of regulatory compliances.
6. Incorporation of risk management.
7. Reduction in production costs and waste.
8. Reduction in product variability, defects and rejections.
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research
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QbD: Objectives
Main outcomes of QbD:
1. Maintenance of product quality to meet
expected clinical performances.
2. Maintenance of product quality by efficient
manufacturing and formulation process.
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QbD: Elements
The following elements can be included in the study of QbD:
1. QTPP (Quality Target Product Profile): This profile is related to
quality, safety and efficacy.
2. CQAs (Critical Quality Attributes): The study of CQAs helps in
the study and
controlling of the product characteristics that have impact on
product quality.
3. Determination of CQAs of drug substances, excipients, etc.
and the selection of the excipients to attain the desired drug quality.
4. Suitable manufacturing process selection.
5. Risk assessment:
CMAs (Critical Material Attributes)
CPPs (Critical Process Parameters)
6. Defining a control strategy.
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QbD
Quality Target Product Profile (QTPP)
It includes:
1. Dosage forms, route of administration, delivery systems.
2. Strength of doses.
3. Container closure system.
4. Pharmacokinetic properties.
5. Drug product quality criteria.
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QbD
Critical Quality Attributes (CQA)
CQA is related with drug substance, excipients, intermediates
(in-process materials) and drug product.
CQA is a physical, chemical, biological or microbiological
property (should be within an appropriate limit, range, or
distribution) to ensure the desired product quality.
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QbD
Risk Assessment: CMAs (Critical Material Attributes) and CPPs
(Critical Process Parameters)
Risk assessment, a science-based method or process, is used
in QRM (Quality Risk Management, mentioned in ICH Q9).
This assessment identifies materials attributes and process
parameters effectively that have an effect on product CQAs.
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research
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QbD
Risk Assessment: CMAs (Critical Material Attributes) and CPPs
(Critical Process Parameters)
This process is utilized in prior pharmaceutical development
process which makes available more information and
knowledge about the development process.
Based on prior knowledge and initial experimental data, risk
assessment method helps to identify and rank different
parameters like process, equipments and input materials
with potential that have an impact on product quality.
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QbD
Control Strategy
It includes the following elements:
1. Control of input material attributes viz., drug substance, excipients,
packaging materials, considering their utilization and effect on product
quality.
2. Product specifications.
3. Controls of unit operations that have a role to maintain the product
quality. The operations may include granulation, drying, degradation,
particle size distribution, etc.
4. In-process testing.
5. Finished product testing.
6. Testing of products at every stage at regular intervals (Monitoring
program).
32. B.PHARM. VII-SEMESTER BP 702 T. INDUSTRIAL PHARMACY-II (Theory)
DR. AJAY K. TIWARI, ASSOCIATE PROFESSOR
MAHARISHI ARVIND COLLEGE OF PHARMACY, JAIPUR (RAJ.)
AJAY81AJAY@GMAIL.COM WHATSAPP: 9782226444
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