Basic understanding on QbD.
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This document discusses Quality by Design (QbD) and Design of Experiments (DoE) principles for drug product development. It aims to develop formulations that reliably deliver the desired pharmacological effects without increasing side effects or losing stability or performance over time. QbD uses a risk-based and knowledge-driven approach to understand critical quality attributes and process parameters that affect product quality. DoE is used to characterize processes and identify sources of variability to ensure consistent manufacturing. The document outlines key ICH guidelines for QbD and DoE and stresses that the goal is achieving a predictable therapeutic response through reproducible, large-scale manufacturing.
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2) International guidelines like ICH Q8, Q9, and Q10 provide a framework for QbD implementation and its benefits like reduced regulatory oversight and manufacturing flexibility.
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2) The key elements of QbD discussed are defining objectives, determining critical quality attributes, risk assessment, experimental design, control strategy, and continuous improvement. Ishikawa and risk assessment methods are also summarized.
3) Implementing QbD provides quality medicines to patients, production improvements for manufacturers, and greater confidence for drug regulators by ensuring predefined product quality objectives.
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Quality by design in pharmaceutical development
This document discusses the concept of Quality by Design (QbD) in pharmaceutical development. It provides background on QbD and outlines its key aspects, including defining target product profiles, critical quality attributes, risk assessment, design space, control strategy, and life cycle management. The benefits of QbD for industry and regulators are described. Traditional and QbD approaches to pharmaceutical development are compared. Tools used in QbD such as design of experiments, risk assessment methodologies, and process analytical technology are also summarized. Finally, an example application of QbD principles to influenza vaccine development is presented.
Quality by design.. ppt for RA (1ST SEM
This document discusses quality by design (QbD) in pharmaceutical development. It begins with introducing QbD as a systematic approach to development that emphasizes product and process understanding based on science and risk management. The key elements of QbD discussed include establishing a quality target product profile, identifying critical quality attributes, conducting risk assessments, defining a design space and control strategy, and enabling continual improvement. A case study demonstrates how QbD improved impurity control for a drug substance. Overall, the document provides an overview of the principles and tools of QbD and its benefits for ensuring quality and facilitating regulatory assessment and flexibility.
Quality assurance tools & techniques
This document discusses concepts of quality assurance in the pharmaceutical industry. It begins with definitions of quality assurance from WHO and ISO. It then discusses the concept of quality assurance, covering all aspects that influence drug quality. Advantages include ensuring high quality drugs while disadvantages include perfection being difficult. Quality assurance tools discussed include total quality management, quality control systems, documentation, validation, and Six Sigma methodology. Total quality management aims to continuously improve quality through participation at all levels. Quality control systems involve qualified staff and standardized procedures. Documentation and validation are important for defining systems and ensuring quality. Six Sigma uses a data-driven approach to reduce defects and improve processes.
Process development
The document discusses the process of developing, optimizing, characterizing, and commercializing a pharmaceutical product. It involves designing a manufacturing process to consistently deliver the intended effects of the drug product. Process development includes determining facility, equipment, materials, procedures, and validation. Optimization compares lead compounds to select those with the greatest potential to be safe and effective medicines. Characterization tests understand the physical and chemical properties of materials. Commercialization requires approvals from regulators and establishing manufacturing, distribution, and marketing capabilities to introduce the product into markets. The goal is to produce a drug that is safe, effective, and affordable to improve patient health.
PST-392 Introduction to Quality Assurance (1).pptx
Introduction to Quality assurance.
According to U.S.F.D.A
“Quality should be built into the product, and testing alone cannot be relied on to ensure product quality”.
Building Quality into the product involves having controls at every stage of manufacturing and not only terminal controls.
These include controls on all input resources like:
people,
facilities,
equipment,
materials,
process
and testing etc.
Qbd1
This document provides an overview of Quality by Design (QbD), a systematic approach to pharmaceutical development that emphasizes product and process understanding based on sound science. The key elements of QbD include defining a Target Product Quality Profile, identifying critical quality attributes and critical process parameters, risk assessment, establishing a design space, and developing a control strategy. The objectives of QbD are to identify important product attributes leading to quality, determine attributes that impact product variability, and establish a design space to allow variability in material attributes.
Seminar on QbD By Dipu.pptx
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.
Quality By Design project work
This document discusses pharmaceutical quality by design (QbD). QbD is a systematic approach that helps in the development of pharmaceutical products by improving quality. The aim of QbD is to design a quality product and manufacturing process to consistently deliver the intended performance. QbD was approved by the FDA to maintain drug product quality before market. The document provides background on QbD and its objectives to achieve quality products and performance testing to ensure a combination of product and process knowledge.
“LET US KNOW ABOUT QUALITY BY DESIGN IN PHARMACEUTICAL INDUSTRY”
The Impression of Quality by configuration protects by demonstrating that quality is simply not a demonstration, yet it is a propensity. As of late Quality by structure (QbD) has increased a lot of consideration among the pharmaceutical business in extremely short course of time . It goes about as a connection between the business and medication administrative specialists for example (FDA), which is predominantly founded on logical, chance based, all encompassing and proactive methodology for advancement of pharmaceutical item. QbD has helped in making the new detailing, and furthermore the structuring of new method of medication conveyance, just as the better approaches for assembling procedure, and attempts to guarantee the predefined quality items . Key attributes of QbD are that it gives an apparatus to centered and effective medication improvement. It is pertinent to diagnostic strategies. Key components of the Quality by configuration are The Quality Target Product Profile (QTPP), Critical Quality Attributes (CAQ), Design space, Control procedure, lifecycle the executives . Use of value by configuration is in different new looks into dependent on HPLC technique, and we give quit estimation of medication conveyance as indicated by the patients BMR , additionally in Quality by Design in Biopharmaceuticals .
3. Section-IN PROCESS QUALITY CONTROL and QUALITY CONTROL.pdf
This document discusses quality control in the pharmaceutical industry. It defines quality control and explains that it is essential to ensure pharmaceutical products are safe, pure, and effective. It describes various in-process quality control tests done at different stages of production for tablets, capsules, syrups, semisolids, and injectables. These tests evaluate attributes like drug content, hardness, dissolution, and sterility. Finally, it compares quality control tests for tablets specified in British, Indian, and US pharmacopeias.
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PST-392 Introduction to Quality Assurance (1).pptx
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“LET US KNOW ABOUT QUALITY BY DESIGN IN PHARMACEUTICAL INDUSTRY”
“LET US KNOW ABOUT QUALITY BY DESIGN IN PHARMACEUTICAL INDUSTRY”
3. Section-IN PROCESS QUALITY CONTROL and QUALITY CONTROL.pdf
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在线办理(salfor毕业证书)索尔福德大学毕业证毕业完成信一模一样
学校原件一模一样【微信：741003700 】《(salfor毕业证书)索尔福德大学毕业证》【微信：741003700 】学位证，留信认证（真实可查，永久存档）原件一模一样纸张工艺/offer、雅思、外壳等材料/诚信可靠,可直接看成品样本，帮您解决无法毕业带来的各种难题！外壳，原版制作，诚信可靠，可直接看成品样本。行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备。十五年致力于帮助留学生解决难题，包您满意。
本公司拥有海外各大学样板无数，能完美还原。
1:1完美还原海外各大学毕业材料上的工艺：水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠。文字图案浮雕、激光镭射、紫外荧光、温感、复印防伪等防伪工艺。材料咨询办理、认证咨询办理请加学历顾问Q/微741003700
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留信网认证的作用:
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3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
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8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
EWOCS-I: The catalog of X-ray sources in Westerlund 1 from the Extended Weste...
Context. With a mass exceeding several 104 M⊙ and a rich and dense population of massive stars, supermassive young star clusters
represent the most massive star-forming environment that is dominated by the feedback from massive stars and gravitational interactions
among stars.
Aims. In this paper we present the Extended Westerlund 1 and 2 Open Clusters Survey (EWOCS) project, which aims to investigate
the influence of the starburst environment on the formation of stars and planets, and on the evolution of both low and high mass stars.
The primary targets of this project are Westerlund 1 and 2, the closest supermassive star clusters to the Sun.
Methods. The project is based primarily on recent observations conducted with the Chandra and JWST observatories. Specifically,
the Chandra survey of Westerlund 1 consists of 36 new ACIS-I observations, nearly co-pointed, for a total exposure time of 1 Msec.
Additionally, we included 8 archival Chandra/ACIS-S observations. This paper presents the resulting catalog of X-ray sources within
and around Westerlund 1. Sources were detected by combining various existing methods, and photon extraction and source validation
were carried out using the ACIS-Extract software.
Results. The EWOCS X-ray catalog comprises 5963 validated sources out of the 9420 initially provided to ACIS-Extract, reaching a
photon flux threshold of approximately 2 × 10−8 photons cm−2
s
−1
. The X-ray sources exhibit a highly concentrated spatial distribution,
with 1075 sources located within the central 1 arcmin. We have successfully detected X-ray emissions from 126 out of the 166 known
massive stars of the cluster, and we have collected over 71 000 photons from the magnetar CXO J164710.20-455217.
Randomised Optimisation Algorithms in DAPHNE
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Aleš Zamuda: Randomised Optimisation Algorithms in DAPHNE .
Austrian-Slovenian HPC Meeting 2024 – ASHPC24, Seeblickhotel Grundlsee in Austria, 10–13 June 2024
https://ashpc.eu/
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Exposé invité Journées Nationales du GDR GPL 2024
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原版纸张【微信：741003700 】【(carleton毕业证书)卡尔顿大学毕业证】【微信：741003700 】学位证，留信认证（真实可查，永久存档）offer、雅思、外壳等材料/诚信可靠,可直接看成品样本，帮您解决无法毕业带来的各种难题！外壳，原版制作，诚信可靠，可直接看成品样本。行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备。十五年致力于帮助留学生解决难题，包您满意。
本公司拥有海外各大学样板无数，能完美还原海外各大学 Bachelor Diploma degree, Master Degree Diploma
1:1完美还原海外各大学毕业材料上的工艺：水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠。文字图案浮雕、激光镭射、紫外荧光、温感、复印防伪等防伪工艺。材料咨询办理、认证咨询办理请加学历顾问Q/微741003700
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
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Isolation of pure culture, its various method.
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Basic understanding on QbD.
- 1. QbD and DoE’s Basics DR PRASHANT KHEMARIYA
- 2. Objective(s) To achieve a predictable therapeutic response to a drug included in a formulation which is capable of large scale manufacture with reproducible product quality. To turn a drug substance into a viable medicinal product which delivers the drug to the right place at the right time in the right quantity to exert the desired effect, by… Ensuring that the drug product is sufficiently stable that it reproducibly and reliably affects the desired pharmacological response- no loss of activity. no loss of performance. no increase in side effects.
- 3. Understanding about QbD and DoE A Quality System for managing a product's life cycle. Risk and knowledge based decisions. Multifunctional exercise. A regulatory expectation. Systemic approach for products and process thereby decrease patient risk.
- 4. QbD and DoE ICH Q8-Q11 Risk management QTPP (Quality Target Product Profile Critical Attribute Critical Process Parameters Critical Material attribute Analytical control strategy. Process Characterization and continued process verification. Technology transfer Validation protocol, process validation scheme Validation.
- 5. What is out of the box approach ? Common approachOut of the BOX approach
- 6. 10's rule of research Concept Trial Batch Pilot Batch Stability Study Production TIME COST * 1$ * 10 $ * 100 $ * 1,000 $ * 10,000 $ Traditional approach * 10,000 $ Novelization in developmentHigh Low * 100 $ Cost of making changes Ability of implement changes
- 7. Product’s quality during validation Product’s Characteristics Target Upper limit Lower limit Ask yourself which product do you want Which product have poorest quality 1 2 3 4 What is your opinion on product 2 and 3 Confused ? Let me help Costofthequality Got it ? So If I say QUALITY = Compliance With Specification Right or wrong ? Sometimes process increases the cost QUALITY = ON TARGET WITH MINIMUM VARRIATION 1, 2, 3, 4 are products Now What is your opinion on product 2 and 3
- 9. And Finely
- 10. Conclusion The success of bringing a new medicine to the market is the result of a complementary and equally important contribution of scientists working in different scientific fields. As Formulation Development is part of the process of bringing every new drug to the market, the quality of formulation contribution is very critical in the success of new drugs.
- 11. Thanks