Opening Speech delivered before about 400 participants (experienced professionals from Officers to Directors) on 14 Jan 2018 at ICCBS, University of Karachi
(Pharmaceutical Manufacturing Dashboard 2017 Review)
This presentation provides an overview of pharmaceutical manufacturing and regulation. It discusses key performance metrics for the industry in 2017, the importance of safety, efficacy and quality, and outlines the process validation lifecycle. Challenges like inspections, recalls and drug shortages are also addressed. The presentation emphasizes learning, applying science-based approaches, and maintaining a culture of quality.
This document provides an overview and agenda for a full-day workshop on drug regulatory quality in Pakistan. It discusses the importance of pharmaceutical regulation in ensuring drug safety and preventing tragedies. Examples are given of contamination issues and medical product failures that resulted in many deaths. The workshop aims to identify attributes of a quality culture, correct relationships, and rational approaches to regulatory science through discussion of quality metrics and case studies.
Chemometrics, Pharmacometrics and Econometrics Dimensions_of_QualityAjaz Hussain
25 May 2012 Basel, Switzerland. A philosophical exploration - Scientific understanding and risk-based regulatory decisions on Quality by Design. How good are the scientific explanations in regulatory submissions? Scientific explanations yield understanding; quality of explanations differ.What role can Chemometrics, Pharmacometics and Econometrics play? Understanding multidisciplinary (cGMP, CMC, Clin. Pharm., Tox., Clinical, Public Health) perspectives on risk is important. Opportunities; only when the disciplinary divides are bridged. Within the regulatory realm how we set specifications and assess risk have progressed incrementally; at this rate the Vision 2020 may be expected to be visible broadly over time, by 2020?
Visioning the Next Decade: NIPTE-FDA CollaborationAjaz Hussain
NIPTE Seminar at US FDA, 16 March 2016.
QBR as an Organizing Principle for the Proposed NIPTE Center of Excellence for Pharmaceutical Formulations (CEPF)
Behavioral Economics and Managment of Pharmaceutical QbD 25 August 2016Ajaz Hussain
Pharmaceutical knowledge pyramid can be toppled easily!
Serendipitous intersection of Behavioral Economics & CGMP.
Why attention to Behavioral Economics can improve management of QbD work-streams?
How? What (benefits)?
Between regulatory query and response there is Design Space. In that space is our comparability protocol…
We are on a journey to make quality medicines affordable to all. In the 21st Century, this journey will be successful to the extent we recognize that quality has to be built-in by design and that it cannot be tested into products, utilize and improve a global Quality Management System (QMS), and implement science based risk assessment in our decision making. Pharmacopoeias are an integral part of this global QMS and have been setting public or market standards for medical products for many centuries. In the 21st Century, Pharmacopoeias can and should be a champion for the practice of quality by design. To do so most effectively it would be useful to recognize how, in the 21st Century, human factors help and hinder optimal development, and correct interpretation, of public or market standards in design, development, control and manufacturing decisions. To explore this aspect in this presentation, cognitive biases – blind spots or alleys – are collected and organized on topics relevant to this workshop: (a) Impurities & Contaminants, (b) Analytical Method Validation, and (c) Public/market standards and Release Testing. How to confront these biases will be discussed. Steps to help in maximally leveraging the Pharmacopoeias on the 21st Century journey will be highlighted.
CHIR Best Brains Exchange 22 January 2016Ajaz Hussain
Quality of drugs manufactured in emerging economies: Are cost containment strategies heightening the likelihood of substandard drugs in Canada?
What regulatory, policy, and/ or governance changes are needed to address new and increased risks?
How can Canada prevent and reduce health risks that emerge when the pharmaceutical industry adopts globalized production strategies?
Question Based Development to Quality by Design to Continued Process Verification
Does your QbD program delivery confidence in CQA’s?
Does it reduce the risk of development failure?
Does it provide a process which is stable and ‘in control’?
Does it reduce risk of GMP noncompliance?
Are we asking the right question and at the right time?
This presentation provides an overview of pharmaceutical manufacturing and regulation. It discusses key performance metrics for the industry in 2017, the importance of safety, efficacy and quality, and outlines the process validation lifecycle. Challenges like inspections, recalls and drug shortages are also addressed. The presentation emphasizes learning, applying science-based approaches, and maintaining a culture of quality.
This document provides an overview and agenda for a full-day workshop on drug regulatory quality in Pakistan. It discusses the importance of pharmaceutical regulation in ensuring drug safety and preventing tragedies. Examples are given of contamination issues and medical product failures that resulted in many deaths. The workshop aims to identify attributes of a quality culture, correct relationships, and rational approaches to regulatory science through discussion of quality metrics and case studies.
Chemometrics, Pharmacometrics and Econometrics Dimensions_of_QualityAjaz Hussain
25 May 2012 Basel, Switzerland. A philosophical exploration - Scientific understanding and risk-based regulatory decisions on Quality by Design. How good are the scientific explanations in regulatory submissions? Scientific explanations yield understanding; quality of explanations differ.What role can Chemometrics, Pharmacometics and Econometrics play? Understanding multidisciplinary (cGMP, CMC, Clin. Pharm., Tox., Clinical, Public Health) perspectives on risk is important. Opportunities; only when the disciplinary divides are bridged. Within the regulatory realm how we set specifications and assess risk have progressed incrementally; at this rate the Vision 2020 may be expected to be visible broadly over time, by 2020?
Visioning the Next Decade: NIPTE-FDA CollaborationAjaz Hussain
NIPTE Seminar at US FDA, 16 March 2016.
QBR as an Organizing Principle for the Proposed NIPTE Center of Excellence for Pharmaceutical Formulations (CEPF)
Behavioral Economics and Managment of Pharmaceutical QbD 25 August 2016Ajaz Hussain
Pharmaceutical knowledge pyramid can be toppled easily!
Serendipitous intersection of Behavioral Economics & CGMP.
Why attention to Behavioral Economics can improve management of QbD work-streams?
How? What (benefits)?
Between regulatory query and response there is Design Space. In that space is our comparability protocol…
We are on a journey to make quality medicines affordable to all. In the 21st Century, this journey will be successful to the extent we recognize that quality has to be built-in by design and that it cannot be tested into products, utilize and improve a global Quality Management System (QMS), and implement science based risk assessment in our decision making. Pharmacopoeias are an integral part of this global QMS and have been setting public or market standards for medical products for many centuries. In the 21st Century, Pharmacopoeias can and should be a champion for the practice of quality by design. To do so most effectively it would be useful to recognize how, in the 21st Century, human factors help and hinder optimal development, and correct interpretation, of public or market standards in design, development, control and manufacturing decisions. To explore this aspect in this presentation, cognitive biases – blind spots or alleys – are collected and organized on topics relevant to this workshop: (a) Impurities & Contaminants, (b) Analytical Method Validation, and (c) Public/market standards and Release Testing. How to confront these biases will be discussed. Steps to help in maximally leveraging the Pharmacopoeias on the 21st Century journey will be highlighted.
CHIR Best Brains Exchange 22 January 2016Ajaz Hussain
Quality of drugs manufactured in emerging economies: Are cost containment strategies heightening the likelihood of substandard drugs in Canada?
What regulatory, policy, and/ or governance changes are needed to address new and increased risks?
How can Canada prevent and reduce health risks that emerge when the pharmaceutical industry adopts globalized production strategies?
Question Based Development to Quality by Design to Continued Process Verification
Does your QbD program delivery confidence in CQA’s?
Does it reduce the risk of development failure?
Does it provide a process which is stable and ‘in control’?
Does it reduce risk of GMP noncompliance?
Are we asking the right question and at the right time?
TransCelerate Overview - Value of Safety Information Data Sources InitiativeTransCelerate
This document provides an overview of TransCelerate BioPharma Inc., a non-profit organization collaborating across the biopharmaceutical industry. It specifically discusses one of TransCelerate's pharmacovigilance initiatives aimed at evaluating the value of different data sources for drug safety information and reporting. The initiative seeks to identify high-value valid safety cases and develop a method for aggregate reporting of lower-value cases, with the goals of improving patient safety, increasing efficiencies, and aligning with health authorities. Near-term objectives include defining data sources, creating a data source hierarchy of value, and gathering evidence to support the hierarchy.
On FDA’s Guidance on Pharmaceutical Process Validation (2011)lAjaz Hussain
Connectors between Culture – Metrics – Continued Process Verification in Process Validation?
Confidence is a critical quality attribute. CGMP violations erode confidence and increase nocebo effects. Currently – “breaches in assurance of data integrity” is a global concern. Have exposed the prevailing ‘regulator heterogeneity’. Re-building ‘epistemic trust” is difficult generally; more so with US FDA. Some thoughts on how to ....
IGPA Building a Culture of Quality Ajaz Hussain_5 Sept 2015_Rferences minAjaz Hussain
Improving Confidence in Quality of Medicines . We make two products – medicine and evidence (documents) but many forget this and do not pay attention to documentation.
Level of attention to documentation is a “canary in a coal mine”
Breaches are irrational –”System 1 thinking” and cognitive biases.
Culture of Quality is familiar to all of us – a framework proposed
Quality Metrics – great idea – very much needed; but we are not yet ready for an FDA Guidance.
We must first address our collective blind spots; be confident that process validation truly ensures complexity is sufficiently reduced and that outcomes are predictable.
We are defining the problem too narrowly. Our paradigm of pharmaceutical quality sifted long-ago. We have harmonized on a regulatory methodology for QbD (e.g., ICH Q8). However, with the prevailing ontological gaps (for example as illustrated in the continuing challenges posed with the current FDA’s Inactive Ingredient Database) - How good are the scientific explanations in regulatory submissions? Is quality risk-assessment - metaphysical or an epistemological category?
Totality of Evidence & Theraputic Equivalence 15 October 2016Ajaz Hussain
Put R back in R&D & recognize It is a “complex” product and process!
Invest smartly in analytics, mathematics & statistics, and large sample sizes; and in systems/integrative thinking and data integration
Get to know the RLD – multiple lots; open the door with large sample size
Build capability to justify measured RLD variability is relevant to development of the proposed generic/biosimilar
Exquisite regulatory communication strategy
This is not a ‘complicated process’ for which typical “good practices” will work seamlessly (e.g., typical project management approach); this is a complex process – with multiple interactions and “emergent properties”
Treat it as it is - a complex process and plan; anticipate and address “emergent issues” - in technical, regulatory and legal dimensions; at a certain point be prepared for stakeholder (payers, patient groups,..) communications
This document discusses challenges in assuring pharmaceutical quality and proposes solutions. It begins with two case examples of companies reaching a "tipping point" in moving from reactive to proactive quality approaches. It then outlines how to effectively integrate process analytical technology (PAT) guidance and other quality guidelines to make continual improvement normal, easy and rewarding. Finally, it proposes understanding uncertainty and human factors when assuring quality, and providing a framework to classify gaps to address challenges. The overall message is that recognizing legacy issues and integrating quality approaches can help advance from problem-solving to error prevention.
QbD and CoQ IDMA Mumbai 24 March 2015 slideshareAjaz Hussain
IDMA – UL SUMMIT 24 March 2015, Mumbai
"Evolving Quality Culture in Indian Pharmaceutical Industry“: Strengthening Our Culture of Quality
Organizational Culture, Good or Bad?
Good Regulators of Pharmaceuticals (GRP) 22 October 2014Ajaz Hussain
Sharing thoughts on what makes a Good Regulator of Pharmaceuticals with pharmacy students at the Universities of Minnesota and Iowa. A point of emphasis on "we all are regulators" is explained and three areas for learning - (a) Systems and Integrative Thinking, (b) Argumentation and (c) Behavioral Economics described.
I hope you, the viewers, will also find some value in reviewing these slides. If you are a student and have some questions please feel free to drop me a email (a2zpharmsci@msn.com).
Dr Venkateswarlu Memorial Lecture 2015Ajaz Hussain
Purpose of this talk is to request you to consider the following 4 Steps
1. Strengthening the ‘Culture of Quality’ – the focus of this talk
2. Improve efficiency with confidence in controls by integrating India’s engineering and statistical know-how and technologies
3. Working together – ‘One Quality for All’ to say proudly – Made in India: Pharmaceutical Factory to the World
4. Leverage India’s Wisdom Traditions to provide leadership in setting the standards for Integrative Medicine so as to deliver a model of ‘Health Care for All’: Pharmacy to the World.
This document announces a professional development session on the pharmaceuticals dashboard for 2021. It will discuss topics like uncertainty in quality, the future of manufacturing and regulations, and competitiveness with trade barriers. The session aims to help professionals mature their skills and align with emerging expectations. It will use tutorials, discussions, examples and case studies. Participant assessment will be confidential. The session facilitators have extensive regulatory experience in Pakistan and international agencies. It will be held on December 19th in Karachi with a small group size.
Placebo and Standard of Care Data Sharing Initiative - PSoC Data SharingTransCelerate
This document outlines 7 potential use cases for sharing clinical trial data across pharmaceutical companies. The use cases are: 1) Enhanced safety signal interpretation, 2) Reduced size of the control arm, 3) Precision powering by minimizing missing data, 4) Inclusion/exclusion criteria optimization, 5) Model-based enhanced trial design, 6) Clinical feasibility optimization by understanding geographic influences, and 7) Biomarker development. For each use case, the document discusses the potential impact, applications, scope, and enhancements over usual practices.
Part 1: FDA Trends
Background: The little secret – swept under the rug? No more!
Challenge or opportunity: Unprecedented juxtaposition – at the Tipping Point!
Questions: What consideration are needed for building your validation roadmap? Three options: Pathfinder, Standard or Emergency; what will you choose?
Part II: A higher level of confidence in quality assurance : State of Control (stability, capability with statistical confidence)
Case example: Challenges of implementing a roadmap to process capability for some currently commercialized products.
A platform for assurance & efficiency - Ajaz at USP PCM Mumbai 2017Ajaz Hussain
Why? Assurance is a critical to quality attribute
What? The Little Secret which erodes assurance patients need
How? Rapid development, design space and real-time control; mind shift
Regulatory Aspects of Continuous Pharmaceutical ManufacturingAjaz Hussain
The document discusses regulatory aspects of continuous pharmaceutical manufacturing. It summarizes that historically there has been regulatory opposition to new manufacturing techniques, but there is now a tipping point with regulatory preference shifting towards real-time controls, continuous manufacturing, and digital approaches. It outlines options for companies to either lead regulatory guidance, follow upcoming standards, or react in an emergency if inspections find issues. The overall message is that serious consideration is needed to develop a roadmap for modernizing manufacturing approaches.
Critical Path Initiative Challenges: FDA ACPS Meeting 19 October 2004Ajaz Hussain
Each section within P2 can have an impact on the other P2 sections and similarly other sections of a submission and to CGMP’s By recognizing this as a complex design system that involves multiple attributes, goals, constraints, multidisciplinary design teams (subsystems), different degrees of uncertainty, risk tolerance, etc., we wish to find opportunities to identify robust designs and design space that provides a sound basis for risk assessment and mitigation
The IFPAC Session: Controlling excipient impact during the product lifecycle.
Excipients enable the delivery of actives as a pharmaceutical product. Quality by Design requires that the impact of excipient variability on finished product quality be minimized, or, as paraphrased by Tobyn: - What matters doesn’t vary, and what varies doesn’t matter.
This parallels the current practice of categorizing excipients into critical vs non-critical, the assumption being that the latter do not impact the finished product Critical Quality Attributes. This binary classification of criticality has been criticized as too simple and it is not uncommon to observe excursions in finished product quality correlating with variability of a so-called non-critical excipient. The complexity of the excipients, and the products into which they are formulated, contributes to this uncertainty. For excipients, what varies may not have mattered prior to approval, but may come to matter later in the product lifecycle, especially for continuously manufactured products with real time release.
Excipients, even if fully compliant and manufactured under GMP, represent a reservoir of special cause variability in finished product quality. By definition this can only be addressed via the Control Strategy. Risk management requires continuous multivariate monitoring of finished product and raw materials to maintain quality and model fidelity.
Insights on Culture of Quality What have I Learned 22 September 2015Ajaz Hussain
Why criticality of CGMPs not widely appreciated as expected by the customer (US FDA)?
What “norms” provide reasons to rationalize cGMP deviations?
How a company can re-build lost credibility? Better option improve credibility?
Re-thinking Pharmaceutical Technology Continuing Education in the Context of ...Ajaz Hussain
I wonder, seriously - Does working in some of the current GXP regulated environments impede adult human development?
Anticipating a glimpse of a framework for a 21st Century Pedagogy - One Quality Voice , continually developing professionals and improving PQS – in the interest of patients and the next generation of professionals.
Pictorial report of cck discussion forum (14 jan 2018) sheebaurooj
1) The document summarizes an opening note for a discussion forum on reviewing the 2017 Pharmaceutical Manufacturing Dashboard held at the International Center for Chemical and Biological Sciences (ICCBS) at the University of Karachi.
2) It recognizes the recent passing of Khalid Yousaf, a pharmacist who contributed greatly to the profession through his work and sharing of knowledge. The session is dedicated in his memory.
3) The note discusses the fast-paced changes in the pharmaceutical industry and regulatory environment, including new drug development, generic competition, regulatory policy shifts, and technological advances like cell-based therapies. It aims to provide an open platform for discussion to help the industry best contribute to healthcare and society.
DIA Global Forum: Are Clinical Trials Ready to Embrace the IoE?Jackie Brusch
The Internet of Everything (IoE) is having a major impact across many industries by connecting people, processes and data on a single network. The IoE brings opportunities to make clinical trials more efficient, cost-effective and less intrusive by enabling devices, sensors and applications to connect to healthcare systems via the internet. This allows for remote patient monitoring and the collection of real-time objective data from devices and wearables. The constant flow of rich data allows investigators to remotely manage patients' health, which has potential to speed up drug development times. However, clinical trials have yet to fully embrace the IoE and changes may be needed to regulations and processes to realize the IoE's benefits for research.
TransCelerate Overview - Value of Safety Information Data Sources InitiativeTransCelerate
This document provides an overview of TransCelerate BioPharma Inc., a non-profit organization collaborating across the biopharmaceutical industry. It specifically discusses one of TransCelerate's pharmacovigilance initiatives aimed at evaluating the value of different data sources for drug safety information and reporting. The initiative seeks to identify high-value valid safety cases and develop a method for aggregate reporting of lower-value cases, with the goals of improving patient safety, increasing efficiencies, and aligning with health authorities. Near-term objectives include defining data sources, creating a data source hierarchy of value, and gathering evidence to support the hierarchy.
On FDA’s Guidance on Pharmaceutical Process Validation (2011)lAjaz Hussain
Connectors between Culture – Metrics – Continued Process Verification in Process Validation?
Confidence is a critical quality attribute. CGMP violations erode confidence and increase nocebo effects. Currently – “breaches in assurance of data integrity” is a global concern. Have exposed the prevailing ‘regulator heterogeneity’. Re-building ‘epistemic trust” is difficult generally; more so with US FDA. Some thoughts on how to ....
IGPA Building a Culture of Quality Ajaz Hussain_5 Sept 2015_Rferences minAjaz Hussain
Improving Confidence in Quality of Medicines . We make two products – medicine and evidence (documents) but many forget this and do not pay attention to documentation.
Level of attention to documentation is a “canary in a coal mine”
Breaches are irrational –”System 1 thinking” and cognitive biases.
Culture of Quality is familiar to all of us – a framework proposed
Quality Metrics – great idea – very much needed; but we are not yet ready for an FDA Guidance.
We must first address our collective blind spots; be confident that process validation truly ensures complexity is sufficiently reduced and that outcomes are predictable.
We are defining the problem too narrowly. Our paradigm of pharmaceutical quality sifted long-ago. We have harmonized on a regulatory methodology for QbD (e.g., ICH Q8). However, with the prevailing ontological gaps (for example as illustrated in the continuing challenges posed with the current FDA’s Inactive Ingredient Database) - How good are the scientific explanations in regulatory submissions? Is quality risk-assessment - metaphysical or an epistemological category?
Totality of Evidence & Theraputic Equivalence 15 October 2016Ajaz Hussain
Put R back in R&D & recognize It is a “complex” product and process!
Invest smartly in analytics, mathematics & statistics, and large sample sizes; and in systems/integrative thinking and data integration
Get to know the RLD – multiple lots; open the door with large sample size
Build capability to justify measured RLD variability is relevant to development of the proposed generic/biosimilar
Exquisite regulatory communication strategy
This is not a ‘complicated process’ for which typical “good practices” will work seamlessly (e.g., typical project management approach); this is a complex process – with multiple interactions and “emergent properties”
Treat it as it is - a complex process and plan; anticipate and address “emergent issues” - in technical, regulatory and legal dimensions; at a certain point be prepared for stakeholder (payers, patient groups,..) communications
This document discusses challenges in assuring pharmaceutical quality and proposes solutions. It begins with two case examples of companies reaching a "tipping point" in moving from reactive to proactive quality approaches. It then outlines how to effectively integrate process analytical technology (PAT) guidance and other quality guidelines to make continual improvement normal, easy and rewarding. Finally, it proposes understanding uncertainty and human factors when assuring quality, and providing a framework to classify gaps to address challenges. The overall message is that recognizing legacy issues and integrating quality approaches can help advance from problem-solving to error prevention.
QbD and CoQ IDMA Mumbai 24 March 2015 slideshareAjaz Hussain
IDMA – UL SUMMIT 24 March 2015, Mumbai
"Evolving Quality Culture in Indian Pharmaceutical Industry“: Strengthening Our Culture of Quality
Organizational Culture, Good or Bad?
Good Regulators of Pharmaceuticals (GRP) 22 October 2014Ajaz Hussain
Sharing thoughts on what makes a Good Regulator of Pharmaceuticals with pharmacy students at the Universities of Minnesota and Iowa. A point of emphasis on "we all are regulators" is explained and three areas for learning - (a) Systems and Integrative Thinking, (b) Argumentation and (c) Behavioral Economics described.
I hope you, the viewers, will also find some value in reviewing these slides. If you are a student and have some questions please feel free to drop me a email (a2zpharmsci@msn.com).
Dr Venkateswarlu Memorial Lecture 2015Ajaz Hussain
Purpose of this talk is to request you to consider the following 4 Steps
1. Strengthening the ‘Culture of Quality’ – the focus of this talk
2. Improve efficiency with confidence in controls by integrating India’s engineering and statistical know-how and technologies
3. Working together – ‘One Quality for All’ to say proudly – Made in India: Pharmaceutical Factory to the World
4. Leverage India’s Wisdom Traditions to provide leadership in setting the standards for Integrative Medicine so as to deliver a model of ‘Health Care for All’: Pharmacy to the World.
This document announces a professional development session on the pharmaceuticals dashboard for 2021. It will discuss topics like uncertainty in quality, the future of manufacturing and regulations, and competitiveness with trade barriers. The session aims to help professionals mature their skills and align with emerging expectations. It will use tutorials, discussions, examples and case studies. Participant assessment will be confidential. The session facilitators have extensive regulatory experience in Pakistan and international agencies. It will be held on December 19th in Karachi with a small group size.
Placebo and Standard of Care Data Sharing Initiative - PSoC Data SharingTransCelerate
This document outlines 7 potential use cases for sharing clinical trial data across pharmaceutical companies. The use cases are: 1) Enhanced safety signal interpretation, 2) Reduced size of the control arm, 3) Precision powering by minimizing missing data, 4) Inclusion/exclusion criteria optimization, 5) Model-based enhanced trial design, 6) Clinical feasibility optimization by understanding geographic influences, and 7) Biomarker development. For each use case, the document discusses the potential impact, applications, scope, and enhancements over usual practices.
Part 1: FDA Trends
Background: The little secret – swept under the rug? No more!
Challenge or opportunity: Unprecedented juxtaposition – at the Tipping Point!
Questions: What consideration are needed for building your validation roadmap? Three options: Pathfinder, Standard or Emergency; what will you choose?
Part II: A higher level of confidence in quality assurance : State of Control (stability, capability with statistical confidence)
Case example: Challenges of implementing a roadmap to process capability for some currently commercialized products.
A platform for assurance & efficiency - Ajaz at USP PCM Mumbai 2017Ajaz Hussain
Why? Assurance is a critical to quality attribute
What? The Little Secret which erodes assurance patients need
How? Rapid development, design space and real-time control; mind shift
Regulatory Aspects of Continuous Pharmaceutical ManufacturingAjaz Hussain
The document discusses regulatory aspects of continuous pharmaceutical manufacturing. It summarizes that historically there has been regulatory opposition to new manufacturing techniques, but there is now a tipping point with regulatory preference shifting towards real-time controls, continuous manufacturing, and digital approaches. It outlines options for companies to either lead regulatory guidance, follow upcoming standards, or react in an emergency if inspections find issues. The overall message is that serious consideration is needed to develop a roadmap for modernizing manufacturing approaches.
Critical Path Initiative Challenges: FDA ACPS Meeting 19 October 2004Ajaz Hussain
Each section within P2 can have an impact on the other P2 sections and similarly other sections of a submission and to CGMP’s By recognizing this as a complex design system that involves multiple attributes, goals, constraints, multidisciplinary design teams (subsystems), different degrees of uncertainty, risk tolerance, etc., we wish to find opportunities to identify robust designs and design space that provides a sound basis for risk assessment and mitigation
The IFPAC Session: Controlling excipient impact during the product lifecycle.
Excipients enable the delivery of actives as a pharmaceutical product. Quality by Design requires that the impact of excipient variability on finished product quality be minimized, or, as paraphrased by Tobyn: - What matters doesn’t vary, and what varies doesn’t matter.
This parallels the current practice of categorizing excipients into critical vs non-critical, the assumption being that the latter do not impact the finished product Critical Quality Attributes. This binary classification of criticality has been criticized as too simple and it is not uncommon to observe excursions in finished product quality correlating with variability of a so-called non-critical excipient. The complexity of the excipients, and the products into which they are formulated, contributes to this uncertainty. For excipients, what varies may not have mattered prior to approval, but may come to matter later in the product lifecycle, especially for continuously manufactured products with real time release.
Excipients, even if fully compliant and manufactured under GMP, represent a reservoir of special cause variability in finished product quality. By definition this can only be addressed via the Control Strategy. Risk management requires continuous multivariate monitoring of finished product and raw materials to maintain quality and model fidelity.
Insights on Culture of Quality What have I Learned 22 September 2015Ajaz Hussain
Why criticality of CGMPs not widely appreciated as expected by the customer (US FDA)?
What “norms” provide reasons to rationalize cGMP deviations?
How a company can re-build lost credibility? Better option improve credibility?
Re-thinking Pharmaceutical Technology Continuing Education in the Context of ...Ajaz Hussain
I wonder, seriously - Does working in some of the current GXP regulated environments impede adult human development?
Anticipating a glimpse of a framework for a 21st Century Pedagogy - One Quality Voice , continually developing professionals and improving PQS – in the interest of patients and the next generation of professionals.
Pictorial report of cck discussion forum (14 jan 2018) sheebaurooj
1) The document summarizes an opening note for a discussion forum on reviewing the 2017 Pharmaceutical Manufacturing Dashboard held at the International Center for Chemical and Biological Sciences (ICCBS) at the University of Karachi.
2) It recognizes the recent passing of Khalid Yousaf, a pharmacist who contributed greatly to the profession through his work and sharing of knowledge. The session is dedicated in his memory.
3) The note discusses the fast-paced changes in the pharmaceutical industry and regulatory environment, including new drug development, generic competition, regulatory policy shifts, and technological advances like cell-based therapies. It aims to provide an open platform for discussion to help the industry best contribute to healthcare and society.
DIA Global Forum: Are Clinical Trials Ready to Embrace the IoE?Jackie Brusch
The Internet of Everything (IoE) is having a major impact across many industries by connecting people, processes and data on a single network. The IoE brings opportunities to make clinical trials more efficient, cost-effective and less intrusive by enabling devices, sensors and applications to connect to healthcare systems via the internet. This allows for remote patient monitoring and the collection of real-time objective data from devices and wearables. The constant flow of rich data allows investigators to remotely manage patients' health, which has potential to speed up drug development times. However, clinical trials have yet to fully embrace the IoE and changes may be needed to regulations and processes to realize the IoE's benefits for research.
1) The document summarizes the opening speech for a discussion forum on ICH-Q7 and Q11 guidelines at ICCBS University of Karachi.
2) It highlights the importance of collaborative learning across disciplines to effectively deal with challenges in pharmaceutical regulation and ensure patient safety.
3) The speaker commends the "Culture of Cultivating Knowledge" team for disseminating knowledge from previous sessions, which helped pharmaceutical companies save hundreds of millions by clarifying expiry dates of products.
The document provides an overview of the Cracking the Nut Health 2016 conference. It discusses the inspiration and themes of the conference, which are using measurement and analytics to improve accountability, leveraging partnerships to promote resilience, and scaling technology and innovation to increase impact. The keynote speaker, Michael Myers from the Rockefeller Foundation, will discuss building resilient health systems through partnerships, community resources, technology, and innovation. The agenda outlines the welcome remarks, keynote, and subsequent breakout sessions on the first day that will explore these themes through various case studies and projects.
This document discusses patient-centered drug development and clinical trials. It defines patient centricity as meaningfully including patients, particularly in trial protocol design, and linking clinical trial goals with patients' needs and experiences. It emphasizes measuring what matters to patients. While patient centricity is seen as important, there is no consensus on how to measure it. The document explores definitions of patient centricity, challenges in measuring it, examples of companies working to include the patient voice, and the need for new approaches to drug development that place greater focus on the patient experience.
This document discusses patient-centered drug development and clinical trials. It defines patient centricity as meaningfully including patients, particularly in designing trial protocols, and linking clinical trial goals with patients' needs and experiences. It emphasizes measuring what matters to patients. While patient centricity is seen as important, there is no consensus on how to measure it. The document explores how companies are working to include the patient voice, such as through patient advisory boards and surveys to capture patient perceptions and experiences in clinical trials. It argues that simply talking about patient centricity is not enough, and that meaningful action is needed to achieve it.
The document summarizes an upcoming conference on patient-centered clinical trials taking place October 19-20, 2015 in Philadelphia. It will feature over 30 industry experts and leaders from pharmaceutical companies such as Johnson & Johnson, Pfizer, AstraZeneca, and Google. The goal of the conference is to discuss how to better involve patients in the design and conduct of clinical trials to improve recruitment, retention, and trial success by putting the patient voice at the core. It will provide a forum for stakeholders from industry, patient advocacy groups, and regulators to collaborate on developing a framework for patient engagement in clinical trials.
(2286) World Orphan Drug Congress USA 2016 A4 32 Page Brochure 1.5 SCREEN SPREADPinky Fadullon
This document provides information about the 6th Annual Global Orphan Drug Conference and Expo taking place April 21-22, 2016 in Washington D.C. The conference will bring together stakeholders in the orphan drug industry including pharmaceutical companies, patient advocacy groups, regulators, payers, and investors. It will include keynote sessions, workshops on topics like market forecasting and commercialization, and networking opportunities. A pre-conference day of workshops is scheduled for April 20th.
The document discusses innovation in cancer treatment in California. It notes that California companies have hundreds of oncology products in development that could lead to new lifesaving therapies. Continued investment is critical to ongoing research and development of new treatments. The pace of innovation has quickened in recent years, with 29 new cancer treatments approved nationally since 2008 alone.
The ethics of performance monitoring-private sector perspectiveDavid Quek
Increasingly medical practice is coming under intense scrutiny as to what is appropriate and affordable care, including serious considerations of patient safety issues and protection. Medical professionalism must be consciously adhered to as we try and find the best health care for our patients at the best value and outcomes for our patients themselves, and also for society at large. In view of escalating health care costs, physician autonomy to practice as he or she likes or deems fit has now come under siege with more and more performance monitoring, not just for appropriateness, but also for outcomes, necessity and cost-effectiveness. Physician' vested interests must be tempered with evidence-based benefits or at least be associated with no increase in harm or incur affordability issues. Fraudulent physician malfeasance are now being uncovered via whistle-blowers, or through greater more meticulous audit of various validated performance measures, and those physicians found to have flouted these due to pecuniary self-interests, overuse of tests or procedures have been found guilty and sanctioned with heavy fines, return of reimbursements as well as imprisonment, and erasure from medical registries and the removal of license to practice.
The 10 Most Impactful Leaders in Life Science.pdfTHECIOWORLD
This edition features a handful of The Most Impactful Leaders in Life Science that are leading us into a better future
Read More: https://thecioworld.com/the-10-most-impactful-leaders-in-life-science-september2023/
Life sciences a data-driven diagnosis for success, United States, USA, US, US Southeast Region, Christian Dillstrom, Global Growth Ambassador of the USA Southeast Region
Greetings from Virtue Insight,
I am happy to invite you and your colleagues to be a sponsor/ delegate for our upcoming “7th Annual Clinical Trials Summit 2016” The conference will Be held on 14th May 2016, The Lalit Hotel, Mumbai, India.
Following our past six highly successful events, this event focuses on “A Critical Guide for Successfully Conducting “7th Annual Clinical Trials Summit 2016” It gives me great pleasure in welcoming all of you to The Virtue Insight’s “7th Annual Clinical Trials Summit 2016”. I wish and pray that all our efforts will be beneficial to our industries folks at large.
CONFIRMED SPEAKERS FROM :- Takeda Pharmaceuticals (UK), Clinical Research & Development, Cadila, Sanofi Aventis, Johnson & Johnson, GNH India, Clintech India, Boehringer Ingelheim, Reliance Life Sciences, Abbott, Glenmark Pharmaceuticals, Sanofi, Nishith Desai Associates, Novartis, Tata Consultancy Services, Janssen India (Pharmaceutical companies of Johnson & Johnson), SIRO Clinpharm, and few more..
CONFERENCE BOOKING DETAILS:-
• Standard Price (10th April 2016):- 1 or 2 Delegates - (INR 7,000 + Tax (14.5%) per delegate)
• Group Discounts – 3 or 4 Delegates - (INR 6,500 + Tax (14.5%) per delegate)
• Group Discounts – 5 and above Delegates - (INR 5,500 + Tax (14.5%) per delegate)
• Conference Sponsor & Exhibition Stall - Should you wish to Sponsor, or purchase a Exhibition Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to TEL: + 91 9171350244 or deepak@virtueinsight.co.in, deepakrajvirtueinsight@gmail.com
In case you or any of your colleagues might be interested in participating in the same, please let me know and I will be happy to call you and help you with the registration.
Thank you for your time and consideration. I look forward to hearing from you.
PS: - Please refer your friends or colleagues by forwarding this email to anyone you think may benefit from it.
Best Regards,
Deepak Raj
Delegate and Sponsorship Sales
Virtue Insight
Gsm - + 91 9171350244
Tel - + 91 44 65515693
Skype - edeepakraj143
Most Influential Canadian Women Leaders in Healthcare, 2024 January 2024.pdfinsightscare
As we step into a new era of healthcare leadership, it is both a privilege and a responsibility to present to you our special edition: “Most Influential Canadian Women Leaders in Healthcare, 2024.” While the Canadian healthcare system has made commendable strides in embracing diversity, it is crucial to acknowledge that there is still a considerable distance to cover.
The article discusses how public health laboratories are adapting to new technologies for tuberculosis (TB) testing. At a recent conference, participants debated how to best integrate promising new diagnostic methods like whole genome sequencing while maintaining existing effective testing paradigms. Speakers emphasized the need for laboratories to collaborate and provide accurate, cost-effective information, as well as properly interpret new test results in the context of clinical evidence and conventional test results. Emerging technologies are causing laboratories to reevaluate their testing approaches to make the most of new and existing tools for TB diagnosis and treatment.
This document discusses opportunities for innovation with AVIA. It begins by outlining the author's experience in management, sales, innovation, framework development, planning, and touchpoint management. It then provides examples of cases the author has worked on, including Pfizer and Firestone. The document also summarizes the author's audit of AVIA and its market to develop ideas. It emphasizes that health care delivery needs massive-scale innovation to achieve higher performance and sustainable affordability in the face of rising costs, an aging population, new technologies, and expanding coverage.
The document discusses clinical trials and subjects. It emphasizes that behind every successful clinical trial are thousands of subjects. It highlights the important role and responsibilities of subjects in clinical trials. It also discusses challenges in subject compliance and retention, and provides some solutions sites can implement, such as education, training, relationship building, and sensitization of subject responsibilities. The document advocates for including vulnerable populations in clinical trials.
Lexington Health Practice 'The future of Market Access' Interactive PamphletEmily Stevenson
Lexington Health Practice recently held a breakfast event to discuss the future for market access in England. The breakfast, the first in a series, examined the Health Technology Appraisal (HTA) environment and facilitated a discussion amongst individuals who work closely with and amongst the pharmaceutical industry, examining how the mechanisms in place can be improved to ensure equitable access to medicines.
From surviving to thriving: cancer’s next challengePwC Russia
Рак-диагноз, который никто не хочет услышать. Приуроченный к Всемирному дню борьбы с раком отчет PwC рассказывает об историях тех, кто пережил этот страшный период жизни и не сдался.
This document introduces a new organization called the Global Healthspan Policy Institute (GHPI) that aims to shape public policy around preventing aging-related diseases and extending healthy lifespans. GHPI recognizes aging as the biggest challenge facing societies today and seeks to transform how governments approach population aging through supporting innovative treatments and technologies. The document outlines several medical breakthroughs that could impact aging, such as metformin, senolytics, regenerative medicine, and gene therapies, and argues that with the right policy reforms these approaches could keep people healthier for longer and reduce healthcare costs.
Similar to KHALID YOUSUF SAHAB DASHBOARD 2017 REVIEW (20)
The document discusses anti-thymocyte globulin (ATG), which is used for acute organ rejection. ATG is produced from rabbits that are inoculated with human T lymphocytes to trigger an antibody response. The antibodies produced in rabbits are then extracted, purified, and administered to patients to kill arrays of lymphocytes. Developing a process to characterize the target globulin and transferring knowledge will help establish protein production. Key challenges include maintaining clean environments and aseptic extraction, purification, and filling processes.
The document discusses establishing the OR Centre for Quality Sciences to provide consulting services to the pharmaceutical and biologics industries regarding quality, regulatory affairs, innovation, and technology. It aims to engage subject matter experts to support academia, industry, and government. The Centre will focus on shifting from a compliance to a quality culture and aligning with new regulatory expectations in a changing technological landscape with advances in areas like artificial intelligence and data sciences. It will provide training, reviews, audits, and other services to support quality systems, documentation practices, regulatory submissions, clinical trials, and more.
An article on contamination of Diethylene Glycol in Pharmaceuticals. Thanks to Dr. Ajaz S. Hussain for all teaching, sharing knowledge and supporting in professional development.
The document announces a training on demonstrating a quality management system during inspections to be held on September 30, 2023 in Kotri, Sindh. It will provide participants with techniques for showcasing compliance and procedures when regulatory audits occur. A list of attendees is included but not summarized for brevity.
The document provides tips for demonstrating a quality management system during an inspection. It advises being simple, clear, truthful, and confident when welcoming inspectors. Assign specific duties to staff and have flexibility. Listen fully to questions before responding, and don't argue - say you will look into issues. Practice mock inspections, recognize potential problems, and maintain your system daily.
The document discusses the services provided by the Centre for Quality Sciences, which include designing new and upgrading existing pharmaceutical manufacturing facilities, conducting GMP audits and training, assisting with regulatory submissions, and providing consulting services regarding quality systems, data integrity, and compliance strategies. The Centre's vision is to shift the industry towards a quality culture through knowledge sharing and facilitating discussions to develop strategic roadmaps. It aims to help companies strengthen quality compliance and sustain their quality management systems in the changing regulatory landscape.
The document discusses biomarkers, which are measurable indicators of biological states or conditions. It describes biomarkers as tools that can help facilitate medical product development. The document outlines different types, categories, and descriptions of biomarkers. It discusses how biomarkers can be qualified and approved by regulatory agencies like the FDA for specific contexts of use. The document provides examples of biomarkers that have been used for various purposes, such as assessing disease diagnosis, treatment effectiveness, and safety. It also summarizes some biomarkers that have been qualified or considered for qualification by the FDA.
1) The document discusses the evolution of ensuring drug quality from relying solely on testing to emphasizing proper manufacturing processes and controls.
2) It explains that without understanding the entire manufacturing process, one cannot say a drug is consistent in quality and purity or free of contamination.
3) Current good manufacturing practices (cGMP) help assure drug safety and efficacy by requiring facilities to control manufacturing operations through quality management systems and robust operating procedures.
The document discusses neurotoxicity and neurodegeneration in drug development. It notes that safety issues, especially related to the cardiovascular system and central nervous system, are among the most common reasons for drug development failure. Biomarkers for early detection of potential neurotoxicity could help improve success rates by facilitating safety screening earlier in the development process. The central nervous system is particularly vulnerable, as neurotoxicity is a frequent cause of failure in both pre-clinical and clinical phases of development.
Mr. Atiq ur Rahman has over 27 years of experience in pharmaceutical manufacturing and supply chain management. He has expertise in facility design, quality audits, and regulatory compliance. More recently, he has worked on data engineering, data acquisition, and applying data science concepts in pharmaceutical and other process industries. The presentation provides an overview of the industrial revolutions from Industry 1.0 to 5.0 and defines Pharma 4.0 as the convergence of people, systems, and data within a singular network powered by artificial intelligence. It discusses strategies for digital transformation and achieving digital maturity, including evaluating current technology needs and creating a roadmap with goals and timelines.
The document discusses the relationship between PIC/S and ICH and their roles in harmonizing GMP standards globally. PIC/S focuses specifically on GMP inspections and developing harmonized GMP standards and training inspectors. ICH focuses more broadly on safety, efficacy, quality and regulatory guidelines. Together they aim to promote reliance between regulatory authorities and open doors of trust through mutual recognition agreements and understanding of inspection systems. The document provides a comprehensive overview of their goals and collaboration to harmonize standards for patients worldwide.
The document discusses a presentation on quality issues observed by the FDA during inspections of pharmaceutical facilities in 2022. It notes the FDA observed deficiencies related to lack of written SOPs, insecure data, failure to investigate out of specification results, cleaning issues, and missing environmental monitoring programs. The document also presents a case study of a facility that had a significant media fill failure in November 2021 but did not initiate a recall until April 2022, exposing patients to risk. It describes poor aseptic techniques observed by FDA investigators during manufacturing operations.
The filling machine and HEPA filter located directly above the filling machine in the filling room were significantly discolored with an unknown substance. This indicates potential contamination issues that need to be investigated and addressed. Facilities should ensure machinery and equipment are properly cleaned and maintained to prevent contamination that could compromise product quality.
The document discusses the pressure of real-world evidence on pharmaceutical regulatory science. It mentions the author's experience interacting with international regulatory agencies like the FDA, EU, Health Canada, and MHRA. It lists some references on topics like continuous manufacturing and real-time dissolution prediction. The document emphasizes that improving individual parts of a system will not improve the overall system, and that a systems approach to quality is needed.
This document provides information about an upcoming training session on Good Manufacturing Practices. The session will be held on October 16th in Karachi and will run from 9:00 am to 3:00 pm. It is aimed at pharmaceutical professionals with backgrounds in pharmacy, chemistry, microbiology and related fields. Experts from the US pharmaceutical industry will discuss advancements in manufacturing technology and emerging regulatory changes. The session will include tutorials, discussions, and Q&A to help participants better understand GMP requirements and ensure quality assurance. Participants will pay Rs. 10,000 or Rs. 5,000 depending on whether they are attending as part of their job. More details and contact information are provided.
This document contains questions and answers related to pharmaceutical quality and manufacturing. It discusses topics like clean hold time, dirty hold time, contamination control strategies, particles in injections, the differences between CMC, GMP, and continuous manufacturing. It also addresses questions about PIC/S, such as whether they issue membership, if inspections by one country are accepted by others, and that GMP certificates are issued by individual regulatory authorities rather than PIC/S.
This document discusses issues that may arise with generic drugs compared to innovator drugs. Bioequivalence studies only show equivalence at a single point in time and do not guarantee equivalence over the lifetime of the drug. Manufacturing the drug involves many variables like people, equipment, materials that could result in potency and dissolution differences compared to the innovator. The document provides data that showed increased hospitalization rates for certain generics compared to the innovator drug. It emphasizes the need for consistent quality manufacturing to ensure patient safety.
The document discusses several topics related to improving drug quality including:
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2) Errors must be eliminated through quality by design in development and operational excellence, and companies must continuously improve rather than just fixing problems.
3) Digital transformation, identifying critical quality attributes, and moving to more flexible and integrated quality systems will help address issues and improve patient outcomes.
This document appears to be a scanned receipt from a restaurant in New York City listing various food and drink items purchased, with a subtotal of $86.62 and total including tax of $97.45. The receipt details a variety of appetizers, entrees, drinks and desserts ordered for multiple guests.
This document discusses key elements of good manufacturing practices (GMP) for pharmaceutical manufacturing. It covers topics like building layout, equipment, utilities, documentation, materials, production processes, packaging, quality systems, facilities, laboratories and ensuring the safety, efficacy and quality of pharmaceutical products. The overall message is that GMP provides a foundation and framework to establish process and quality control, validate operations, continuously improve and ultimately ensure that pharmaceutical products meet their intended quality standards.
A presentation on mastering key management concepts across projects, products, programs, and portfolios. Whether you're an aspiring manager or looking to enhance your skills, this session will provide you with the knowledge and tools to succeed in various management roles. Learn about the distinct lifecycles, methodologies, and essential skillsets needed to thrive in today's dynamic business environment.
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KHALID YOUSUF SAHAB DASHBOARD 2017 REVIEW
1. Opening Note at Discussion Forum on Pharmaceutical Manufacturing Dashboard 2017 Review
(14th
Jan 2018 at ICCBS, University of Karachi)
Mrs. Roohi Bano Obaid
Deputy Director/ Civil Service Officer,
Drug Regulatory Authority, Government of Pakistan
Alumni, CDER Forum of International Regulators, US-FDA, Maryland
Alumni, HPFB Forum of International Regulators, Health Canada, Ottawa
Member International Society of Pharmaceutical Engineering (ISPE)
Member Parenteral Drug Association (PDA)
Indeed it is my great privilege to express our gratitude on behalf of CCK. Thank you very much for being with us,
for walking with us by great patience, for great enthusiasm to learn, and last but not the least for evolving visible
overwhelming spirits to support others. CCK is so gratified to see the extending coordination among participants and
extending volunteers engagements with us through CCK page on Facebook, through Google application and through
What’s App. You are aware that CCK does not charge any fee and all working behind is voluntary and free from
any financial interest. We leave it upon you to answer questions outside the CCK that why and how CCK is able to
do it. The beauty of discussions, its uniqueness, novelty and non-obviousness remains a source of energy and hope
among all of us Allhamdolilah.
Let me allow to share with you the recent death of our beloved Khalid Yousaf Sahab who always shared his
knowledge with generosity. He was a pharmacist by degree from Karachi University, studied further in USA and
was a registered pharmacist in USA till his death. He worked in Novartis for decades and we have very special
regards for him due to his contribution to the profession, affection and dignity. He will be deeply missed.
CCK has tried to provide opportunities of learning that may contribute in national progress. Like all other multiple
fields of science new innovations and technology in pharmacy and medicine seems to be committed to provide
treatment of disease like inherent diseases that may never be thought possible. Patients own immune cells are re-
engineered now to target their own cancer cells. Paradigm shift in every field is unpredictable. So the safety affairs
are much more challenging than ever before. On the other hand, the global world is encouraging generic competition
by reducing the potential misuse of scientific hitches to block entry of generic drugs, simplifying obstacles to
resolve scientific and regulatory concerns as well as reshaping the regulatory policy and framework in more
predictable and efficient way. Entry of generic products reduces prices and increase accessibility and its huge
contribution in healthcare system can never be undermined.
CCK is trying to provide both a platform and hope to our pharmaceutical circle for respecting the science and
discussion to achieve the best future and best contribution to the healthcare profession and society that would be
proven worthy for our generations. We understand the relationship between opportunities and progress but at the
same time we see deprivation proven as a great constituent of success. In any case, time is going fast, world is
becoming a global village and to live with grace we must not waste our time, we must not be rigid, we must not be
intolerant.
Our world has entered in a fast train that is designed with the ability to reshape its frames by default and align it with
the mission of protection and advancement of health. Our journey from gene therapy to biological intervention, from
multiple cycle review to smart review, from independence to interdependence, from traditional approach to risk
based approach, from science to super science, from truth to integrity, from hope to assurance in the business of
drug manufacturing is striding more progressively and smartly than ever before. About 04 new molecules per month
are coming out to reduce the disease burden and improve the quality of life and this speed have never been
witnessed in the history what we know.
Today we all will be taking part in great discussion that will remain focus on challenges, innovations and changes
this world is experiencing. We had decided in last meeting of CCK that we would dedicate the session with the
name of Khalid Yousuf Sahab, that’s why let me allow opening the Khalid Yousuf Sahab session of Dashboard
2017 Review. Have a very good day.