Emerging Phenomena & Challenges
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The document discusses emerging challenges related to ICH Q8 and Q10 implementation, including increased risk and non-compliance due to process variability. It also discusses how quality inspectors and assessors can evaluate product control strategy, quality by design, manufacturing processes, and change management systems. The rest of the document focuses on knowledge management, data integrity, and quality metrics as indicators of operational reliability and quality culture. Key quality metrics discussed include lot acceptance rate, product quality complaint rate, right first time rate, invalidated OOS rate, APR/PQR on time rate, CAPA rate, and ability to initiate voluntary CAPA.
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Petition of the Day
This document discusses the application of ICH Q8 and Q10 principles to pharmaceutical product development and manufacturing. It begins with an example of a dissolution failure incident to highlight the importance of understanding products and processes. It then outlines tools and approaches like knowledge management and quality risk management that can be used from development through commercial manufacturing following ICH Q8 and Q10 guidelines. Finally, it provides a case study example of how these principles were applied to the development of the drug Saxagliptin.
Closing Messages
1) Dr. Obaid Ali discussed the appropriate use of Quality Risk Management (QRM) to facilitate regulatory compliance without removing industry's obligation to adhere to requirements.
2) The document defines key terms related to quality risk management including harm, hazard, hazardous situation, risk, residual risk, severity, and detectability based on ICH Q9 and ISO 14971.
3) Regulatory observations from authorities in France, South Africa, and the US FDA are presented that highlight failures to adequately perform risk assessment and management.
Regulatory Approaches in Site Selection for Inspections
Regulatory agencies prioritize manufacturing sites for inspection based on factors like probability and severity of issues, detectability of problems, site age and recall history, product usage and therapeutic importance, and risk management considerations. New sites and older sites with past recalls pose higher risks, while commonly used drugs like paracetamol present more risk than others. Effective risk management across strategic, operational, financial and compliance areas can help influence prioritization under ICH Q9 guidelines.
Modern Regulatory Approaches & Tools in Pharmaceutical Manufacturing
QRM is a systematic process that facilitates communication and transparency between industry and regulators. It helps move organizations from a reactive "fire fighting" approach to a proactive risk management approach. The level of effort for QRM should be based on the level of risk, and always link back to protecting patient safety. QRM considers various tools and methodologies, both qualitative and quantitative, to assess and control risk across a product's lifecycle. The overall goal is a common understanding of quality risk management between industry and regulators.
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A structured approach to the investigation process should be used with the objective of determining the root cause.
The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9.
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CAPA: Using Risk-Based Decision-Making Toward Closure
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Applying the methods of determining risk to the device’s complete life cycle will give your company a complete look at all of the device’s risks—including those relative to processes. Manufacturers should be able to justify that they have reduced the risks as far as possible as part of their risk management plan and ongoing corrective and preventive actions.
Capa ‘Bellwether’
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Petition of the Day
This document discusses the application of ICH Q8 and Q10 principles to pharmaceutical product development and manufacturing. It begins with an example of a dissolution failure incident to highlight the importance of understanding products and processes. It then outlines tools and approaches like knowledge management and quality risk management that can be used from development through commercial manufacturing following ICH Q8 and Q10 guidelines. Finally, it provides a case study example of how these principles were applied to the development of the drug Saxagliptin.
Closing Messages
1) Dr. Obaid Ali discussed the appropriate use of Quality Risk Management (QRM) to facilitate regulatory compliance without removing industry's obligation to adhere to requirements.
2) The document defines key terms related to quality risk management including harm, hazard, hazardous situation, risk, residual risk, severity, and detectability based on ICH Q9 and ISO 14971.
3) Regulatory observations from authorities in France, South Africa, and the US FDA are presented that highlight failures to adequately perform risk assessment and management.
Regulatory Approaches in Site Selection for Inspections
Regulatory agencies prioritize manufacturing sites for inspection based on factors like probability and severity of issues, detectability of problems, site age and recall history, product usage and therapeutic importance, and risk management considerations. New sites and older sites with past recalls pose higher risks, while commonly used drugs like paracetamol present more risk than others. Effective risk management across strategic, operational, financial and compliance areas can help influence prioritization under ICH Q9 guidelines.
Modern Regulatory Approaches & Tools in Pharmaceutical Manufacturing
QRM is a systematic process that facilitates communication and transparency between industry and regulators. It helps move organizations from a reactive "fire fighting" approach to a proactive risk management approach. The level of effort for QRM should be based on the level of risk, and always link back to protecting patient safety. QRM considers various tools and methodologies, both qualitative and quantitative, to assess and control risk across a product's lifecycle. The overall goal is a common understanding of quality risk management between industry and regulators.
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A structured approach to the investigation process should be used with the objective of determining the root cause.
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CAPA: Using Risk-Based Decision-Making Toward Closure
Implementing a risk‐based CAPA process within a QMS is a necessity in the improvement of controls aligned with product and process non-conformances, adverse events, audit findings, complaints, etc. Making decisions concerning scope and extent about these “defectives” is a modern and cost-saving approach to improvement and compliance. Every non-conformity does not force you to open a corrective action. While almost every problematic issue needs at least a correction, the biggest payback is to use corrective actions on systemically-driven problems that are repetitive and recurring.
Applying the methods of determining risk to the device’s complete life cycle will give your company a complete look at all of the device’s risks—including those relative to processes. Manufacturers should be able to justify that they have reduced the risks as far as possible as part of their risk management plan and ongoing corrective and preventive actions.
Capa ‘Bellwether’
A CAPA (corrective and preventative action) program is an important indicator of a company's overall compliance efforts. It is considered a "bellwether" by the FDA. An effective CAPA program follows a closed-loop process to identify, correct, and eliminate quality issues and potential problems. It analyzes multiple sources of quality data. Failing to properly establish and maintain CAPA procedures is a common violation cited by the FDA. Ensuring a strong CAPA program that satisfies regulations like ISO 13485 and 21 CFR Part 820 can help reduce compliance risks during FDA inspections.
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Stephen.Gershen.Quality
Total Quality Management (TQM) focuses on meeting customer needs and expectations. It views quality as characteristics that satisfy customer needs. TQM involves all departments and aims to continuously improve processes through techniques like statistical process control and quality assurance. Leading thinkers like Deming, Juran, Crosby, Ishikawa, and Taguchi contributed approaches still used today like continuous improvement, zero defects, and design of experiments.
Stephen.Gershen.Quality
Total Quality Management (TQM) focuses on meeting customer needs and expectations. It views quality as the totality of characteristics and features that impact a product or service's ability to satisfy needs. TQM involves all departments and aims to continuously improve processes through techniques like statistical process control, quality planning, and reducing variation. Leading thinkers like Deming, Juran, Crosby, Ishikawa, and Taguchi contributed approaches to TQM still used today like PDCA cycles, cost of quality analysis, and design of experiments.
Stephen.Gershen.Quality
Total Quality Management (TQM) aims to meet customer needs through continuous improvement. It evolved from quality control to quality assurance to TQM. Key thinkers include Deming, Juran, Crosby, Ishikawa, Taguchi, and Imai. Deming emphasized reducing variability and management commitment. Juran developed the quality trilogy. Crosby defined quality as conformance to requirements. Taguchi focused on minimizing loss. Toyota Production System principles include just-in-time production and respect for people. TQM aims to eliminate waste and ensure customer satisfaction.
Week 4Quality ManagementOPERATIONS MANAGEMENT.docx
Week 4:
Quality Management
OPERATIONS MANAGEMENT
1
Outline
Quality definition
Dimension of quality in product and services
Quality assurance
Quality leaders
Cost of quality
Total quality management and tools
Definition of Quality
Quality is a predictable degree of uniformity and dependability, at low cost and suitable to the market (Deming)
Quality is fitness for use (Juran)
Quality is the conformance to requirements (Crosby)
Quality is the (minimum) loss imparted by a product to
society from the time the product is shipped. (Taguchi)
Why Quality
4
Managing quality supports differentiation, low cost, and response strategies
Quality helps firms increase sales and reduce costs
Building a quality organization is a demanding task
4
Ethics and Quality Management
5
Operations managers must deliver healthy, safe, quality products and services
Poor quality risks injuries, lawsuits, recalls, and regulation
Organizations are judged by how they respond to problems
5
Dimensions of Quality for Manufacturing Product
Performance: Product’s primary operating characteristics
Features: Secondary characteristics that supplement the products basic functioning
Reliability: The probability of a product’s surviving over a specified period of time under stated conditions of use
Durability: The amount of use one gets from a product before it physically deteriorates or until replacement is preferable.
Serviceability: The ability to repair a product quickly and easily
Aesthetics: How a product looks, feels, tastes, or smells
Service Quality Attributes
Timeliness: Will a service be performed when promised?
Completeness: Are all items in an order included?
Courtesy: Do front-line employees greet each customer cheerfully and politely.
Consistency: Are services delivered in the same fashion for every customer and every time for the same customers.
Accessibility and convenience: Is the service easy to obtain?
Accuracy: Are the services performed right the first time?
Responsiveness: Can the service personnel response quickly and resolve unexpected problem?
Quality Control
All those operational techniques and activities that are used to fulfill requirements for quality.
The objectives are:
(i) To ensure true expression/correct translation of stated and implied needs of the customers.
(ii) To monitor the process for realization of the product at various stages of its operations and eliminating causes of unsatisfactory performance at all stages of quality loop in order to achieve economic effectiveness.
(iii) Inspection of the product/service package to determine conformance to customer needs.
Quality Assurance
All the planned and systematic activities implemented within the organization for quality management, to provide adequate confidence that a product or service will satisfy given requirements for quality (ISO - International Organization for Standardization).
Quality assurance is a preventive activity an.
Lecture 2: QA and Qc in Pharma Industry
Quality assurance and quality control play important roles in the pharmaceutical industry to ensure product safety and efficacy. Quality assurance focuses on preventing defects through process improvement and monitoring, while quality control identifies defects through testing of raw materials, in-process materials and finished products. Both functions are necessary to consistently deliver high quality products that do not compromise consumer health. Key responsibilities of quality assurance include overseeing quality systems, monitoring validation activities and investigating issues like deviations. Quality control responsibilities involve testing, method validation, complaint investigation and stability studies. Together quality assurance and quality control form a quality culture from design through manufacturing and distribution.
Quality Assurance
This document discusses quality assurance and quality management. It defines key concepts like quality assurance, quality control, and quality management. It also covers topics like testing, verification and validation, risk management, and quality models and standards. The overall message is that quality assurance aims to implement the right processes and prevent defects, while quality control finds defects through testing, and quality management achieves maximum customer satisfaction through continuous improvement.
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Reasons for quality becoming a cardinal priority for most organizations:
Competition – Today’s market demand high quality products at low cost. Having `high quality’ reputation is not enough! Internal cost of maintaining the reputation should be less.
Changing customer – The new customer is not only commanding priority based on volume but is more demanding about the “quality system.”
Obstacles of Quality -(change ,poor habits , adherence , misconceptions)
Cost of Quality
Culture of Quality - Part II (Updated & Reproduced) 03 Aug-2019
The document discusses creating a sustainable culture of quality in the pharmaceutical industry. It provides examples of key quality metrics such as lot acceptance rate, product quality complaint rate, and invalidated OOS rate that can be used to measure the state of quality. It also identifies attributes that are essential for a quality culture, such as leadership emphasis on quality, message credibility, peer involvement, and employee ownership. The document emphasizes that a strong quality culture is needed to support an efficient quality system and outlines some of the visible signals and roots of a strong quality culture.
Quality investment by Amr Gwaily
This document discusses how quality practices can help a company achieve its objectives in 7 key areas:
1. Increase market share by visiting markets to assess customer satisfaction and address complaints.
2. Meet sales demands by using quality procedures to assess maintenance and ensure continuous production.
3. Increase productivity by using quality to optimize operating conditions and machine/operator performance.
4. Increase product availability by using quality to control raw material storage and manage inventory levels.
5. Eliminate sources of production downtime by addressing repeated quality defects and implementing process improvements.
6. Increase utilization of plant resources by using quality to minimize waste and optimize use of materials, energy, and equipment.
7. Ensure best execution of company objectives
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Tutotrial - 3; Creating & Sustaing a Culture of Quality
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B.为什么我们提供的毕业证成绩单具有使用价值？
查询留服认证是国内鉴别留学生海外学历的唯一途径，但认证只是个体行为，不是所有留学生都操作，所以没有办理认证的留学生的学历在国内也是查询不到的，他们也仅仅只有一张文凭。所以这时候我们提供的和学校颁发的一模一样的毕业证成绩单，就有了使用价值。
实体公司，专业可靠，办理加拿大毕业证|办美国成绩单|做德国文凭学历认证|办新西兰学位证，办澳洲文凭认证，办留信网认证（网上可查，实体公司，专业可靠）铸就十年品质！信誉！实体公司！
文凭办理流程：
1客户提供办理信息：姓名生日专业学位毕业时间等（如信息不确定可以咨询顾问：微信95270640我们有专业老师帮你查询）；
2开始安排制作毕业证成绩单电子图；
3毕业证成绩单电子版做好以后发送给您确认；
4毕业证成绩单电子版您确认信息无误之后安排制作成品；
5成品做好拍照或者视频给您确认；
6快递给客户（国内顺丰国外DHLUPS等快读邮寄）。
7完成交易删除客户资料
高精端提供以下服务：
一：皇后大学皇后大学毕业证文凭证书全套材料从防伪到印刷水印底纹到钢印烫金
二：真实使馆认证（留学人员回国证明）使馆存档
三：真实教育部认证教育部存档教育部留服网站可查
四：留信认证留学生信息网站可查
五：与学校颁发的相关证件1:1纸质尺寸制定（定期向各大院校毕业生购买最新版本毕,业证成绩单保证您拿到的是鲁昂大学内部最新版本毕业证成绩单微信95270640）
A.为什么留学生需要操作留信认证?
留信认证全称全国留学生信息服务网认证,隶属于北京中科院。①留信认证门槛条件更低,费用更美丽,并且包过,完单周期短,效率高②留信认证虽然不能去国企,但是一般的公司都没有问题,因为国内很多公司连基本的留学生学历认证都不了解。这对于留学生来说,这就比自己光拿一个证书更有说服力,因为留学学历可以在留信网站上进行查询!
B.为什么我们提供的毕业证成绩单具有使用价值？
查询留服认证是国内鉴别留学生海外学历的唯一途径但认证只是个体行为不是所有留学生都操作所以没有办理认证的留学生的学历在国内也是查询不到的他们也仅仅只有一张文凭。所以这时候我们提供的和学校颁发的一模一样的毕业证成绩单就有了使用价值。娃拒绝父亲送说往车上一躺就等着下车决无丢失的道理有手机在身联系也方便再说他都岁了还有大半车的小伙伴相伴他不怕在父亲千叮咛万嘱咐中山娃依依不舍地爬上车朝窗外不住地挥手别了父亲别了父亲的城别了我的暑假生活我的城市生活望着窗外挥舞的大手还有那张微驼的背一向坚强的山娃禁不住泪如雨下当我坐下来想写这封信时“感恩两字在我脑海中回旋很幸运我有这样的机会能将埋在心底深深的感激之情得以表达从婴儿的“哇哇坠地到哺育听
Employment Practices Regulation and Multinational Corporations
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原版制作(CDU毕业证书)查尔斯达尔文大学毕业证PDF成绩单一模一样
学校原件一模一样【微信：741003700 】《(CDU毕业证书)查尔斯达尔文大学毕业证PDF成绩单》【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
【主营项目】
一.毕业证【q微741003700】成绩单、使馆认证、教育部认证、雅思托福成绩单、学生卡等！
二.真实使馆公证(即留学回国人员证明,不成功不收费)
三.真实教育部学历学位认证（教育部存档！教育部留服网站永久可查）
四.办理各国各大学文凭(一对一专业服务,可全程监控跟踪进度)
如果您处于以下几种情况：
◇在校期间，因各种原因未能顺利毕业……拿不到官方毕业证【q/微741003700】
◇面对父母的压力，希望尽快拿到；
◇不清楚认证流程以及材料该如何准备；
◇回国时间很长，忘记办理；
◇回国马上就要找工作，办给用人单位看；
◇企事业单位必须要求办理的
◇需要报考公务员、购买免税车、落转户口
◇申请留学生创业基金
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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Emerging Phenomena & Challenges
- 1. Emerging Phenomena & Challenges on ICH Q8 & Q10 Obaid Ali Civil Service Officer / Deputy Director, DRAP Member ISPE, PDA
- 2. Drug Substance Operations Pharmaceutical Development Technology Transfer Commercial Manufacturing Drug Product Operations Lifecycle
- 7. Raw material Process Product Variables If something wrong here It has to appear here
- 8. Process Variables Optimize and set during development Controlled as closely as possible during production
- 9. How Inspector and Assessor Integrate To assess Product Control Strategy To assess Quality by Design To verify Effective Manufacturing Process To examine Change Management System
- 11. Knowledge & Risk Management Knowledge derives better understanding An iterative process A systematic approach An enabler
- 13. Knowledge & Risk Management Your knowledge is an asset to your organization & approaches exist to manage as such Your knowledge is a key enabler & can help your organization realize the purpose behind effective PQS
- 14. Knowledge & Risk Management Knowledge needs to flow, grow and evolve across the lifecycle
- 15. Data Integrity
- 16. Quality Metrics Quality Metrics Indicator of operational reliability Quality Culture
- 17. Quality Metrics Lot Acceptance Rate Product Quality Complaint Rate Right first time Rate Invalidated OOS Rate APR or PQR on time Rate CAPA Rate Ability to initiate voluntary CAPA
- 18. Quality Metrics Lot Acceptance Rate Product Quality Complaint Rate Right first time Rate Invalidated OOS Rate APR or PQR on time Rate CAPA Rate Ability to initiate voluntary CAPA
- 19. Quality Metrics Lot Acceptance Rate Product Quality Complaint Rate Right first time Rate Invalidated OOS Rate APR or PQR on time Rate CAPA Rate Ability to initiate voluntary CAPA
- 20. Quality Metrics Lot Acceptance Rate Product Quality Complaint Rate Right first time Rate Invalidated OOS Rate APR or PQR on time Rate CAPA Rate Ability to initiate voluntary CAPA
- 21. Quality Metrics Lot Acceptance Rate Product Quality Complaint Rate Right first time Rate Invalidated OOS Rate APR or PQR on time Rate CAPA Rate Ability to initiate voluntary CAPA
- 22. Quality Metrics Lot Acceptance Rate Product Quality Complaint Rate Right first time Rate Invalidated OOS Rate APR or PQR on time Rate CAPA Rate Ability to initiate voluntary CAPA
- 23. Quality Metrics Lot Acceptance Rate Product Quality Complaint Rate Right first time Rate Invalidated OOS Rate APR or PQR on time Rate CAPA Rate Ability to initiate voluntary CAPA
- 24. Quality Metrics Lot Acceptance Rate Product Quality Complaint Rate Right first time Rate Invalidated OOS Rate APR or PQR on time Rate CAPA Rate Ability to initiate voluntary CAPA
- 25. Lots rejected/total lots in a year Lot Acceptance Rate
- 27. Deviated lots/ total lots in a year Right First Time Rate
- 28. 38/355= Right First Time Rate
- 29. APR triggered CAPA/ total number of APRs Corrective & Preventive Action (CAPA) Rate
- 30. Corrective & Preventive Action (CAPA) Rate 3/30=
- 31. Process capability or performance index for each critical quality attribute that triggers a CAPA Ability to initiate voluntary CAPA
- 32. Ability to initiate voluntary CAPA Cp value
- 33. The number of batches for which complaint received/ total number of batches (very specific to the product) Product Quality Complaint Rate
- 34. Product Quality Complaint Rate 6/30=
- 35. Invalidated initial OOS tests / total number of tests in a year Invalidated OOS Rate
- 37. The number of APRS within 30 days of annual due date / the total number of products produced during the year APR or PQR on time Rate
- 38. APR or PQR on time Rate 05/40=
- 39. Hope you had a good learning Email: cultureofcultivatingknowledge@gmail.com Facebook: Culture of Cultivating Knowledge Thank You