The document discusses Quality by Design (QbD), which is a systematic approach to pharmaceutical development that emphasizes product and process understanding based on sound science. QbD has been adopted by the FDA and aims to design quality into products and manufacturing processes from the beginning. It provides benefits like reduced batch failures, cost savings, and more efficient regulatory oversight. The key aspects of QbD include defining target quality attributes, identifying critical process parameters, establishing a design space, and implementing a risk-based control strategy.
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.
This presentation - Part V in the series- deals with the concepts of Control strategy and PAT. This presentation was compiled from material freely available from FDA , ICH , EMEA and other free resources on the world wide web.
Introduction to manufacturing operations, Sanitation, Cross-contamination, Packaging, IPQC, time limitation, Expiration,Calculation of Yield, Production record review, process deviation
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.
This presentation - Part V in the series- deals with the concepts of Control strategy and PAT. This presentation was compiled from material freely available from FDA , ICH , EMEA and other free resources on the world wide web.
Introduction to manufacturing operations, Sanitation, Cross-contamination, Packaging, IPQC, time limitation, Expiration,Calculation of Yield, Production record review, process deviation
CGMP is current good manufacturing practices followed for achieving good quality product which is effective and safe for patients. USFDA's motto is to protect the health of patients along with biologicals.
EMEA is supposed to take care of medicines for human use as veterinary use.
CDER & CBER are the main branches of USFDA which gives guidelines for drug & biologics.
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
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.
Dissolution : Official and Non official methods, Alternative methods of dissolution testing and transport models, Drug release testing, Invitro drug release testing
Quality Perspective of ‘Good Distribution Practices’ in Indian Pharmaceutical...iosrjce
The operation of Supply Chain of Management (SCM) is predominantly perceived from commercial facet of a
business. Pharmaceutical products affect the health of the user hence it is obligatory to produce and deliver the
products of predetermined quality standards. This can only be achieved by designing quality centric procedures
and pursue them at each stage during distribution process. Quality is considered as the most sensitive aspect of
pharmaceutical business during manufacturing as well as distribution. Quality of medicinal products is
concurrent to its objective of curing the patients. Many drug regulatory agencies have issued guidance ‘Good
distribution practices (GDP)’for pharmaceutical manufactures. The Good Distribution Practices (GDP) is
considered an essential basis of pharmaceutical SCM to ensure systematic distribution of medicinal products.
Due to lack of proper understanding and commitment, product quality issues are noticed by manufacturer’s
quality assurance department. Since most of the quality aspects of pharmaceutical products are not known to
the common patients, the survey to characterise them with help of quality professionals has been found useful.
This research study finds that there is an enhanced need of control over the supply chain management
operations to align its procedure and practices with quality objectives of pharmaceutical ‘Good Manufacturing
Practices (GMP)’
CGMP is current good manufacturing practices followed for achieving good quality product which is effective and safe for patients. USFDA's motto is to protect the health of patients along with biologicals.
EMEA is supposed to take care of medicines for human use as veterinary use.
CDER & CBER are the main branches of USFDA which gives guidelines for drug & biologics.
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
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.
Dissolution : Official and Non official methods, Alternative methods of dissolution testing and transport models, Drug release testing, Invitro drug release testing
Quality Perspective of ‘Good Distribution Practices’ in Indian Pharmaceutical...iosrjce
The operation of Supply Chain of Management (SCM) is predominantly perceived from commercial facet of a
business. Pharmaceutical products affect the health of the user hence it is obligatory to produce and deliver the
products of predetermined quality standards. This can only be achieved by designing quality centric procedures
and pursue them at each stage during distribution process. Quality is considered as the most sensitive aspect of
pharmaceutical business during manufacturing as well as distribution. Quality of medicinal products is
concurrent to its objective of curing the patients. Many drug regulatory agencies have issued guidance ‘Good
distribution practices (GDP)’for pharmaceutical manufactures. The Good Distribution Practices (GDP) is
considered an essential basis of pharmaceutical SCM to ensure systematic distribution of medicinal products.
Due to lack of proper understanding and commitment, product quality issues are noticed by manufacturer’s
quality assurance department. Since most of the quality aspects of pharmaceutical products are not known to
the common patients, the survey to characterise them with help of quality professionals has been found useful.
This research study finds that there is an enhanced need of control over the supply chain management
operations to align its procedure and practices with quality objectives of pharmaceutical ‘Good Manufacturing
Practices (GMP)’
Regulatory oversight of genetic testing in Canada: Health Canada perspectiveMaRS Discovery District
Speaker: Patrice Sarrazin, PhD, Senior Scientific Evaluator, In Vitro Diagnostic Devices, Medical Devices Bureau, Therapeutic Product Directorate, Health Canada. Patrice discusses Health Canada's perspective on genetic testing as well as policy and regulation in Canada.
Part of Dx2010, a workshop at MaRS focused on best practices and regulatory considerations for developing gene-based diagnostic and prognostic tests.
radiation regulatory bodies. ( international + indian )akshayonslideshar
Radiation is harmful . right ? but who is looking after that it is being used in correct manner in hospitals .I have tried to write about some international and indian regulatory bodies.
Annual report 2015 - European Directorate for the Quality of Medicines & Heal...Council of Europe (CoE)
This publication presents the work carried out in 2015 by the European Directorate for the Quality of Medicines & HealthCare, Council of Europe, highlighting its particular achievements.
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
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.”
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.
Key Components of Pharmaceutical QbD, an IntroductionSaurabh Arora
In the past few years, US FDA has implemented the concepts of Quality by Design (QbD) into its approval processes. FDA is insisting that quality should be built into a product with an understanding of the product and process, through development and manufacturing. QbD is a successor to the "quality by QC" (or "quality after design") approach.
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.
The Art Pastor's Guide to Sabbath | Steve ThomasonSteve Thomason
What is the purpose of the Sabbath Law in the Torah. It is interesting to compare how the context of the law shifts from Exodus to Deuteronomy. Who gets to rest, and why?
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.
This is a presentation by Dada Robert in a Your Skill Boost masterclass organised by the Excellence Foundation for South Sudan (EFSS) on Saturday, the 25th and Sunday, the 26th of May 2024.
He discussed the concept of quality improvement, emphasizing its applicability to various aspects of life, including personal, project, and program improvements. He defined quality as doing the right thing at the right time in the right way to achieve the best possible results and discussed the concept of the "gap" between what we know and what we do, and how this gap represents the areas we need to improve. He explained the scientific approach to quality improvement, which involves systematic performance analysis, testing and learning, and implementing change ideas. He also highlighted the importance of client focus and a team approach to quality improvement.
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
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.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
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.
Students, digital devices and success - Andreas Schleicher - 27 May 2024..pptxEduSkills OECD
Andreas Schleicher presents at the OECD webinar ‘Digital devices in schools: detrimental distraction or secret to success?’ on 27 May 2024. The presentation was based on findings from PISA 2022 results and the webinar helped launch the PISA in Focus ‘Managing screen time: How to protect and equip students against distraction’ https://www.oecd-ilibrary.org/education/managing-screen-time_7c225af4-en and the OECD Education Policy Perspective ‘Students, digital devices and success’ can be found here - https://oe.cd/il/5yV
The Indian economy is classified into different sectors to simplify the analysis and understanding of economic activities. For Class 10, it's essential to grasp the sectors of the Indian economy, understand their characteristics, and recognize their importance. This guide will provide detailed notes on the Sectors of the Indian Economy Class 10, using specific long-tail keywords to enhance comprehension.
For more information, visit-www.vavaclasses.com
How to Create Map Views in the Odoo 17 ERPCeline George
The map views are useful for providing a geographical representation of data. They allow users to visualize and analyze the data in a more intuitive manner.
We all have good and bad thoughts from time to time and situation to situation. We are bombarded daily with spiraling thoughts(both negative and positive) creating all-consuming feel , making us difficult to manage with associated suffering. Good thoughts are like our Mob Signal (Positive thought) amidst noise(negative thought) in the atmosphere. Negative thoughts like noise outweigh positive thoughts. These thoughts often create unwanted confusion, trouble, stress and frustration in our mind as well as chaos in our physical world. Negative thoughts are also known as “distorted thinking”.
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
2. Q b D
QbD has been adopted by the U.S. Food and Drug Administration (FDA) for the
discovery, development, and manufacture of drugs
According to ICH Q 8(R1) QbD is defined as:
A systematic approach to development that begins with predefined objectives
It emphasizes on product and process understanding and process control.
It is based on sound science and quality risk management.
FDA PAT Guidelines define QbD as a system for designing, analyzing and
controlling manufacturing through timely measurements (i.e. during processing) of
critical quality and performance attributes of new and in-process materials and
processes, with the goal of ensuring final product safety.
3. SIGNIFICANCE OF QbD :
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
BENEFITS OF QBD:
QbD is good Business
Eliminate batch failures
Minimize deviations and costly investigations
Avoid regulatory compliance problems
Organizational learning is an investment in the future
QbD is good Science
Better development decisions
Empowerment of technical staff
4. The QbD initiative, which originated from the Office of Biotechnology Products
(OBP), attempts to provide guidance on pharmaceutical development to facilitate
design of products and processes that maximizes the product’s efficacy and safety
profile while enhancing product manufacturability
IMPROVEMENTS BY QbD:
Ensure higher level of assurance of product quality for patient
Improved product and process design & understanding
Monitoring, tracking & trending of product & process.
More efficient regulatory oversight
Efficiency and cost saving for industry
Increase efficiency of manufacturing process
Minimize / eliminate potential compliance actions
5. STEPS INVOLVED IN QUALITY BY DESIGN PRODUCTS
1. Development of new molecular entity
Preclinical study
Nonclinical study
Clinical Study
Scale up
Submission for market Approval
2. Manufacturing
Design Space
Process Analytical Technology
Real time Quality Control
3. Control Strategy
Risk based decision
Continuous Improvement
Product performance
6. QBD DEVELOPMENT PROCESS INCLUDE:
Begin with a target product profile that describes the use, safety and efficacy
of the product
Define a target product quality profile that will be used by formulators and
process engineers as a quantitative surrogate for aspects of clinical safety and
efficacy during product development
Gather relevant prior knowledge about the drug substance, potential
excipients and process operations into a knowledge space.
Design a formulation and identify the critical material (quality) attributes of
the final product that must be controlled to meet the target product quality
profile.
Design a manufacturing process to produce a final product having these
critical material attributes.
Identify the critical process parameters and input (raw) material attributes that
must be controlled to achieve these critical material attributes of the final
product.
7. Use risk assessment to prioritize process parameters and material attributes for
experimental verification. Combine prior knowledge with experiments to
establish a design space or other representation of process understanding.
Establish a control strategy for the entire process that may include input material
controls, process controls and monitors, design spaces around individual or
multiple unit operations, and/or final product tests. The control strategy should
encompass expected changes in scale and can be guided by a risk assessment.
Continually monitor and update the process to assure consistent quality.
8. Traditional approach& Enhanced QbDapproach
ASPECTS CURRENT QbD
Pharmaceutical Development
Empirical, Random, Focus on
optimization
Systematic, Multivariate
experiments, Focus on control
strategy and robustness
Manufacturing Process Fixed
Adjustable within design space,
managed by company’s quality
systems
Process Control Some in-process testing
PAT utilized, Process operations
tracked and trended
Product Specification
Primary means of quality control,
based on batch data
Part of the overall quality control
strategy, based on desired product
performance
Control Strategy By testing and inspection
Risk-based control strategy , real-
time release possible
9. ICH Q8, Q9, Q10 GUIDELINES: THE FOUNDATION OF QbD
ICH Guidelines Q8 for Pharmaceutical Development
Q9 for Quality Risk Management,
Q10 for Quality systems are foundation of QbD
Quality by Design relative to ICH
- Concepts aligned
- Design Space - Key to understanding
- Process robustness
- Design of Experiments (DOE)
- Quality management Quality management
Critical Concept: Design Space
Demonstrated to provide assurance of quality
Defined by applicant and reviewed by regulator
10. Defined regulator
Once design space is approved, regulatory post approval change requirements
will be simplified
Approval Inside vs. outside design space Inside space
Regulatory flexibility to operate within the design space Regulatory space.
11. BENEFITS OF IMPLEMENTING QbD FOR FDA
Enhances scientific foundation for review
Provides for better coordination across review, compliance and inspection
Improves information in regulatory submissions
Provides for better consistency
Improves quality of review (establishing a QMS for CMC)
Provides for more flexibility in decision making
Ensures decisions made on science and not on empirical information
Involves various disciplines in decision making
Uses resources to address higher risks
12. Advantages of QbD
Benefits for Industry:
Better understanding of the process.
Less batch failure.
More efficient and effective control of change.
Return on investment / cost savings.
Allows for implementation of new technology to improve manufacturing
without regulatory scrutiny
Improves interaction with FDA –deal on a science level instead of on a
process level
Allows for continuous improvements in products and manufacturing process.
Additional opportunities:
An enhance QbD approach to pharmaceutical development provides
opportunities for more flexible regulatory approaches.