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.
Welcome to the 2017 NIPTE Conference @ USP Ajaz Hussain
Re-thinking Pharmaceutical Technology Continuing Education.
Co-sponsored by the USP.
@ The USP Conference Center,
12601 Twinbrook Parkway, Rockville, MD 20852-1790, USA
Free Registration @
http://www.nipte.org/content/2017-nipte-conference-registration
Need and Urgency for Harmonization and One Quality VoiceAjaz Hussain
We are in the Experience Economy in which the demand for Assurance is increasing exponentially. Our quality systems are improving linearly, and we are falling behind in delivering the assurance needed by patients to realize therapeutic benefits of medicine we deliver. Industry's need to continually improve is urgent, but their ability to do so remains constrained despite the FDA initiatives. To realize FDA's vision of an agile pharmaceutical manufacturing systems ... Without the need extensive regulatory oversight, industry should be encouraged to "self-author" "performance standards" and regulators should harmonize on the global accessibility of the self-authored performance standards.
#AAPS2017 Need and Urgency for Harmonization and One Quality Voice. A. S. Hussain. Insight, Advice & Solutions LLC.
Roadmap to QbD is (should be) a roadmap to adult human developmentAjaz Hussain
Our system is complex, we are in over our heads!
“Ostrich Syndrome” is holding back the Pharmaceutical Quality For the 21stCentury! Some adults continue to develop but at different rates, many do not!
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
How to Build Effective Pharmaceutical Quality Managment System & Self-develop...Ajaz Hussain
Building on the goals of your LIU education and training, we will learn how the Experience Economy has already changed and will continue to change, the healthcare and new drug pricing and development model and how it is impacting generic drugs.
We will use the ICH Q10 model and adopt a system within a system framework to identify common effectiveness measures – Assurance, Availability, Adherence, and Affordability to understand how these may relate improvement of a system and development of individuals (Amgen case example). Finally, we will outline an easy to use/remember framework that we can use as a starting point in writing their a self- development plan.
Systems Engineering of Pharmaceutical Quality by Design 18 December 2017 Alb...Ajaz Hussain
Invitation by Prof. Olivier Lecoq to deliver a lecture at the School of Mines, Albi, France. The topics of interest are connected to the international world of the industrial pharmacy, so the drug development, the product and process quality, the GMP's, the international regulation, the authorities, the industries...
The talk you presented at the "International Rencontres in Pharmaceutical Engineering" in 2004 in Albi, could be an interesting idea to start with if you agree. The keywords being: PAT, FDA, pharmaceutical engineering of the 21st century!
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).
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?
Welcome to the 2017 NIPTE Conference @ USP Ajaz Hussain
Re-thinking Pharmaceutical Technology Continuing Education.
Co-sponsored by the USP.
@ The USP Conference Center,
12601 Twinbrook Parkway, Rockville, MD 20852-1790, USA
Free Registration @
http://www.nipte.org/content/2017-nipte-conference-registration
Need and Urgency for Harmonization and One Quality VoiceAjaz Hussain
We are in the Experience Economy in which the demand for Assurance is increasing exponentially. Our quality systems are improving linearly, and we are falling behind in delivering the assurance needed by patients to realize therapeutic benefits of medicine we deliver. Industry's need to continually improve is urgent, but their ability to do so remains constrained despite the FDA initiatives. To realize FDA's vision of an agile pharmaceutical manufacturing systems ... Without the need extensive regulatory oversight, industry should be encouraged to "self-author" "performance standards" and regulators should harmonize on the global accessibility of the self-authored performance standards.
#AAPS2017 Need and Urgency for Harmonization and One Quality Voice. A. S. Hussain. Insight, Advice & Solutions LLC.
Roadmap to QbD is (should be) a roadmap to adult human developmentAjaz Hussain
Our system is complex, we are in over our heads!
“Ostrich Syndrome” is holding back the Pharmaceutical Quality For the 21stCentury! Some adults continue to develop but at different rates, many do not!
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
How to Build Effective Pharmaceutical Quality Managment System & Self-develop...Ajaz Hussain
Building on the goals of your LIU education and training, we will learn how the Experience Economy has already changed and will continue to change, the healthcare and new drug pricing and development model and how it is impacting generic drugs.
We will use the ICH Q10 model and adopt a system within a system framework to identify common effectiveness measures – Assurance, Availability, Adherence, and Affordability to understand how these may relate improvement of a system and development of individuals (Amgen case example). Finally, we will outline an easy to use/remember framework that we can use as a starting point in writing their a self- development plan.
Systems Engineering of Pharmaceutical Quality by Design 18 December 2017 Alb...Ajaz Hussain
Invitation by Prof. Olivier Lecoq to deliver a lecture at the School of Mines, Albi, France. The topics of interest are connected to the international world of the industrial pharmacy, so the drug development, the product and process quality, the GMP's, the international regulation, the authorities, the industries...
The talk you presented at the "International Rencontres in Pharmaceutical Engineering" in 2004 in Albi, could be an interesting idea to start with if you agree. The keywords being: PAT, FDA, pharmaceutical engineering of the 21st century!
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).
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?
Explaining the behavioral economics context of culture of qualityAjaz Hussain
Thank you for the many comments on Pharmaceutical Culture of Quality presentation. Some of you asked for more information to understand why I based the discussion in the context of behavioral economics (as opposed to, for example, ethics). This slide-deck provides an explanation for my decision to link culture of quality to the dimension of econometric and behavioral economics.
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.
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.
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 ....
Generic non-biological complex drugs DIA CMC Workshop 2017Ajaz Hussain
#DIACMC17
Assigned title for the talk by the organizers:“The need of conducting clinical study for assuring safety and efficacy, as well as a lack of immunogenicity for generic NBCDs”
SUMMARY
Integrated analytical, product and process development to reduce uncertainty in ‘pharmaceutical equivalence’ is the foundation on which confidence in generic drugs rests
Need to leverage the context: RLD “Prescribe-ability” and lot-lot “Switchability” is acceptable
The “sameness” mindset (as opposed to an “equivalence” mindset) poses challenges to evidence ‘synthesis” (not “piece meal” check the box ) in ANDA submissions
Integrated evidence must a priori account for posed/anticipated “legal challenges” intrinsic to the US system
Clinical assessment of Therapeutic Equivalence of generic product intended (i.e., designed) to be equivalent to RLD should only be needed in rare circumstances
When there is a need to provide assurance to non-scientists stakeholders
Currently the FDA’s GADUFA Research and efforts by many in the sector are predominantly focused on developing a “test of bioequivalence”
For most complex products such a test, in and of itself, may be insufficient to ensure therapeutic equivalence over generic product life-cycle
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?
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.
Regulatory Aspects of Continuous Pharmaceutical ManufacturingAjaz Hussain
Digital Pharma Manufacturing RoundtableKronberg, Germany, March 17 2017
A story about manufacturing two products, medicinal product and documented data, and a “little secret”
Real World Success and Development of Pharmaceutical Professionals in the 21...Ajaz Hussain
For the Bombay College of Pharmacy Alumni Association. Their event announcement:
The 21st century has thrown new challenges for the pharmaceutical profession. Learn about professional development in this era to ensure success! Block your date and time for this exciting webinar to be conducted by our accomplished alumni Ajaz Hussain, through the association website www.bcpalumni.org
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?
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?
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.
Pharmaceutical quality decisions are made by multidisciplinary teams (a range of maturity), at different times and in various organizations; understanding of the QbD paradigm and methodology is derived experientially -One Quality Voice is hard to achieve!
Legacy challenges, various ontological assumptions, and weak epistemology curtails knowledge sharing, delays consensus and keeps us trapped in a reactive mode (3rd Order)
The risk of irrational decision making needs to be accounted. ”Cut-paste” or “check-the-box” practices are reminders that we are not achieving an optimal integration or practicing systems thinking.
A reactive approach (3rd Order) to filling the noted gaps poses risk of continued erosion in the confidence the public should have in our assurance of pharmaceutical quality
We need a thoughtful, planned approach to filling these gaps –NIPTE should take on this challenge! Will it?
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?
Visiting My Alma mater University of Cincinnati 20 April 2017Ajaz Hussain
On a recent visit to my alma mater, University of Cincinnati, I shared my thoughts in a talk entitled Epistemology and a Medicine Maker: If I Could Send a Message Back in Time? What was the message - build self-confidence based on facts and not fake news by practicing questioning how do I know what I know (epistemology) before choosing the appropriate feeling or emotional response. This practice will help to feel (build emotional state) based on facts. This practice can become your pursuit of (true) happiness. See: Epistemology necessary to break the Procrustean bed: 4+ Order of Consciousness & Pharm. Quality which posted on LinkedIn, March 23, 2016.
Sharpen your Unique Sensing Proclivity: Dissolution is a process in mind and ...Ajaz Hussain
Self-authorship bridging the Academia to Industry (A2I) Gap. The challenge in our systems asking why signifies ignorance. Perhaps until a correction is needed. But after corrective and preventive actions (CAPA) often nothing changes. Errors reoccur and we acquire an “immunity to change.”
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)
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?
NIPTE for Pharmaceutical Technology & Education 2018Ajaz Hussain
Little Secret: Unverified assumptions; adequate education, training & experience. Professional development; Elephant in the Dark. The Nation needs a “Critical Mass” of pharmaceutical professionals. We have 18 glinting candles, it is flooding all over; floodlights are needed. One Voice of suitable timber and consistency; improve awareness of opportunities NIPTE can offer.
Three Lessons to Help Accelerate Pharmaceutical Breakthroughs for CNS DisordersQPS Holdings, LLC
"Developing therapies for diseases of the central nervous system (CNS) presents special challenges directly related to the complexity of the human brain and its function of integrating our communications with the outside world. Animal models of human neurological and psychiatric disorders are scarce, because many of these human diseases do not naturally occur in animals, and their study necessitates either specific manipulation (induced models) or the production of genetically modified rodents (transgenic and KO models). Even with these models, it remains unclear, what behavioral domain really resembles higher brain function in humans, and how we can interpret animal data on cognition, emotion, social interaction or activities of daily living.
Furthermore, in contrast with other organs, the CNS is sequestered from the general circulation by the blood brain barrier (BBB), potentially preventing many compounds from reaching their intended target. Quantifying how much of and how long a compound resides in the CNS is difficult and indirect. Therefore, the assessment of target engagement calls for specific techniques and know-how. While animal models provide some information as to how well a given compound accesses the brain, this data cannot always be translated directly to humans. Insufficient knowledge of target-compound interaction may be a major cause of failure in drug development for CNS disorders.
QPS understands the specific challenges of translation from animal models to human clinical application. Our extensive experience in CNS affords us a clear view of its complexities and its current global clinical study environment. Our direct links with the international scientific community and close relationships with key opinion leaders worldwide, together with our dedicated experts, original strategies and operational transparency, are keys to the effective execution of CNS programs for our clients."
Explaining the behavioral economics context of culture of qualityAjaz Hussain
Thank you for the many comments on Pharmaceutical Culture of Quality presentation. Some of you asked for more information to understand why I based the discussion in the context of behavioral economics (as opposed to, for example, ethics). This slide-deck provides an explanation for my decision to link culture of quality to the dimension of econometric and behavioral economics.
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.
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.
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 ....
Generic non-biological complex drugs DIA CMC Workshop 2017Ajaz Hussain
#DIACMC17
Assigned title for the talk by the organizers:“The need of conducting clinical study for assuring safety and efficacy, as well as a lack of immunogenicity for generic NBCDs”
SUMMARY
Integrated analytical, product and process development to reduce uncertainty in ‘pharmaceutical equivalence’ is the foundation on which confidence in generic drugs rests
Need to leverage the context: RLD “Prescribe-ability” and lot-lot “Switchability” is acceptable
The “sameness” mindset (as opposed to an “equivalence” mindset) poses challenges to evidence ‘synthesis” (not “piece meal” check the box ) in ANDA submissions
Integrated evidence must a priori account for posed/anticipated “legal challenges” intrinsic to the US system
Clinical assessment of Therapeutic Equivalence of generic product intended (i.e., designed) to be equivalent to RLD should only be needed in rare circumstances
When there is a need to provide assurance to non-scientists stakeholders
Currently the FDA’s GADUFA Research and efforts by many in the sector are predominantly focused on developing a “test of bioequivalence”
For most complex products such a test, in and of itself, may be insufficient to ensure therapeutic equivalence over generic product life-cycle
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?
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.
Regulatory Aspects of Continuous Pharmaceutical ManufacturingAjaz Hussain
Digital Pharma Manufacturing RoundtableKronberg, Germany, March 17 2017
A story about manufacturing two products, medicinal product and documented data, and a “little secret”
Real World Success and Development of Pharmaceutical Professionals in the 21...Ajaz Hussain
For the Bombay College of Pharmacy Alumni Association. Their event announcement:
The 21st century has thrown new challenges for the pharmaceutical profession. Learn about professional development in this era to ensure success! Block your date and time for this exciting webinar to be conducted by our accomplished alumni Ajaz Hussain, through the association website www.bcpalumni.org
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?
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?
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.
Pharmaceutical quality decisions are made by multidisciplinary teams (a range of maturity), at different times and in various organizations; understanding of the QbD paradigm and methodology is derived experientially -One Quality Voice is hard to achieve!
Legacy challenges, various ontological assumptions, and weak epistemology curtails knowledge sharing, delays consensus and keeps us trapped in a reactive mode (3rd Order)
The risk of irrational decision making needs to be accounted. ”Cut-paste” or “check-the-box” practices are reminders that we are not achieving an optimal integration or practicing systems thinking.
A reactive approach (3rd Order) to filling the noted gaps poses risk of continued erosion in the confidence the public should have in our assurance of pharmaceutical quality
We need a thoughtful, planned approach to filling these gaps –NIPTE should take on this challenge! Will it?
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?
Visiting My Alma mater University of Cincinnati 20 April 2017Ajaz Hussain
On a recent visit to my alma mater, University of Cincinnati, I shared my thoughts in a talk entitled Epistemology and a Medicine Maker: If I Could Send a Message Back in Time? What was the message - build self-confidence based on facts and not fake news by practicing questioning how do I know what I know (epistemology) before choosing the appropriate feeling or emotional response. This practice will help to feel (build emotional state) based on facts. This practice can become your pursuit of (true) happiness. See: Epistemology necessary to break the Procrustean bed: 4+ Order of Consciousness & Pharm. Quality which posted on LinkedIn, March 23, 2016.
Sharpen your Unique Sensing Proclivity: Dissolution is a process in mind and ...Ajaz Hussain
Self-authorship bridging the Academia to Industry (A2I) Gap. The challenge in our systems asking why signifies ignorance. Perhaps until a correction is needed. But after corrective and preventive actions (CAPA) often nothing changes. Errors reoccur and we acquire an “immunity to change.”
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)
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?
NIPTE for Pharmaceutical Technology & Education 2018Ajaz Hussain
Little Secret: Unverified assumptions; adequate education, training & experience. Professional development; Elephant in the Dark. The Nation needs a “Critical Mass” of pharmaceutical professionals. We have 18 glinting candles, it is flooding all over; floodlights are needed. One Voice of suitable timber and consistency; improve awareness of opportunities NIPTE can offer.
Three Lessons to Help Accelerate Pharmaceutical Breakthroughs for CNS DisordersQPS Holdings, LLC
"Developing therapies for diseases of the central nervous system (CNS) presents special challenges directly related to the complexity of the human brain and its function of integrating our communications with the outside world. Animal models of human neurological and psychiatric disorders are scarce, because many of these human diseases do not naturally occur in animals, and their study necessitates either specific manipulation (induced models) or the production of genetically modified rodents (transgenic and KO models). Even with these models, it remains unclear, what behavioral domain really resembles higher brain function in humans, and how we can interpret animal data on cognition, emotion, social interaction or activities of daily living.
Furthermore, in contrast with other organs, the CNS is sequestered from the general circulation by the blood brain barrier (BBB), potentially preventing many compounds from reaching their intended target. Quantifying how much of and how long a compound resides in the CNS is difficult and indirect. Therefore, the assessment of target engagement calls for specific techniques and know-how. While animal models provide some information as to how well a given compound accesses the brain, this data cannot always be translated directly to humans. Insufficient knowledge of target-compound interaction may be a major cause of failure in drug development for CNS disorders.
QPS understands the specific challenges of translation from animal models to human clinical application. Our extensive experience in CNS affords us a clear view of its complexities and its current global clinical study environment. Our direct links with the international scientific community and close relationships with key opinion leaders worldwide, together with our dedicated experts, original strategies and operational transparency, are keys to the effective execution of CNS programs for our clients."
Emergency: “No-pain No-gain”
Standard: “Plan Do Check & Act”
Pathfinders: B1: “Don’t Use & Don’t Tell”; no more!
B2: Every vertex can be a Tipping Point
G1: Same and Similar
G2: Synthesis & Analysis
Excipient Knowledge Management Mumbai 12 March 2015 Part 1 & 2Ajaz Hussain
Why attention to excipient knowledge management (specifically their functionality) is critical to mitigating risks (or to leverage opportunities) posed by the rapidly increasing complexity and uncertainty
Note: Knowledge management in the context of ‘intellectual property’ is not the focus of this talk
Culture of Quality Bagladesh AAPS 8 August 2015 FinalAjaz Hussain
Why we are discussing Culture of Quality?
What is Culture of Quality?
How can it help?
The American public is facing unprecedented drug shortages and recalls (erosion of confidence)
Industry and the FDA have the shared obligation to reduce quality errors …
To fulfill this responsibility, both industry and the FDA need a culture of quality.
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…
Different hats, same needs: Marketing compliance from doctor’s office to boar...Prolifiq Software
At the Marcus Evans 2011 Pharma Marketing Summit on May 4th, GPP blogger Jonathan Sackier presented a physician’s take on Good Promotional Practices for pharmaceutical and medical device sales, including four actionable strategies for marketing compliance.
Please enjoy our Brain Health Bulletin #7! Please feel free to forward this to anyone who may find benefit in receiving it! The Brain Health Bulletin is designed to be your quick reference to the latest information about brain health information, research, technology, cultural awareness for effective, inclusive, and compassionate treatment, care partner tools, and more!
To catch the latest episode of our new podcast, go to The Resilient Caregiver: Empowering Those Who Serve People Diagnosed with Dementia • A podcast on Anchor
This presentation focuses on informed decision making in clinical practice making use of evidence based practice. It addresses the use of PICO to formulate clinical question, searching the evidence/literature, critically appraising the evidence, and application of the evidence to improve the quality of clinical practice
From Deming to Orders of ConsciousnessAjaz Hussain
It is very easy to feel “in over our head” in an increasingly complex world. CGMP Regulations (written in 1997) required “education, training or experience”; these regulations need to be updated. Traditional education (e.g., chemistry, pharmacy, etc.) is not adequately preparing students for the demands of the real world. Systems proficiency is a stage in adult development; we must take responsibility for our self-development and support development of others.
NIPTE, A Community of Knowledge at 2019 Research ConferenceAjaz Hussain
The nation’s “Pharmaceutical Technology” faculty: Distributed (as it should be) but sparsely, integrated with NIPTE
Nation’s attention on its pharmaceutical technology faculty
Increasing awareness of threats and vulnerabilities
Impactful solutions
The NIPTE Model: Team Science & Education for Pharmaceuticals
Integrating systems: Solutions for the real-world
DeciBio Perspectives on Pain Points, Unmet Needs, and Disruption in Precision...Andrew Aijian
We conducted interviews with precision medicine KOLs to create a map of the precision medicine stakeholder landscape and identify and understand the unmet needs and pain points within precision medicine, as well as areas and scenarios of potential disruption.
ICH Guidelines Effective for Regulating Quality of Medicines?Ajaz Hussain
ICH Guidelines: Effective tools for regulating the quality of medicines? Enabling regulatory considerations – the ICH Q8 – 12 are such considerations. Effective implementation of enabling regulatory considerations is a challenge. The challenge is what we know and what we can implement are two different things. Education, training, and experience linked to measures of professional development, as it relates to PQS, should bridge what we know and what we implement. What are such measures? Some corporations are already focused on making their PQS effective (e.g., Amgen) but most are not. In a global supply chain (with ~ 90% of Rx being generics) this can pose a major challenge to deliver assurance patients need. Why? #education #medicine #assurance #regulations #globalization #corporations #bridging #measurements
Similar to Re-thinking Pharmaceutical Technology Continuing Education in the Context of Pharmaceutical Quality for the 21st Century (20)
A Leapfrog Need and Opportunity for mAbsAjaz Hussain
Leapfrogging on reforming mAbs policies makes sense, and doing so can be a principled duty of care.
SMART Technology, SMART Professionals, SMART Services, SMART Organization.
SMART Quality by Design Applications Not Submissions in 2024Ajaz Hussain
Many generic pharma companies seeking regulatory approval uncritically follow “past” practices and prior knowledge. Few, if any, correct errors and innovate to improve past expertise and techniques. The idea of SMART "QbD in ANDApplications" (not “submission”) builds on this observation.
Intuitively Moving Institutions Towards Global Regulatory Resilience Ajaz Hussain
From my experience, how can I describe an intuitive and self-organizing social force around "attractors" patients' value to be assured of therapeutic equivalence?
Critical Importance of Pharmaceutical Traceability in the Experience.pdfAjaz Hussain
From a narrow viewpoint, serialization is just a process of printing an identifying number on products and shipping cases.
From a long-term view, the integration of serialization numbering systems with the production line as well as the quality control procedures required to maintain the integrity of the numbers.
Validation 4 for Credible Pharma 4 a Keynote for Valconnect 2023.pdfAjaz Hussain
The notion of Validation 4.0 in the title of this keynote relates to the development and maturity of people and professionals, which I will elaborate on in the context of the ValGenesis experiences [of its users and service providers].
Validation 4.0 in this talk is about internal assurance, self-assurance, and self-authoring policies, plans, and procedures, ideally without the need [to wait] for FDA guidance.
SMART Triaxial Compaction, Social Form 483 and VAI or OAI to an Avenger.pdfAjaz Hussain
Why did the company not design and formulate a tablet that did not “cap”? Why wouldn’t NIH fund my proposal for CAFD? Why did the FDA [discount] Pharmaceutical Development Reports, while in the EU and Japan, is it an essential part of the regulatory review?
Under a hypothetical social inspection scheme, a report submitted in 2010 is imagined as PM 483 in the spirit of FDA Form 483 of “Inspectional Observations.”
What do the noted observations suggest about my professional maturity or state of mind at that event in 2010? What would be an appropriate “feedback” response?
Statistical Thinking and Pharmaceutical Professional Development, a keynote b...Ajaz Hussain
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An Updating Perspective on BAD I in March Madness 2023.pdfAjaz Hussain
Why does it take decades to acknowledge the obvious? Something to ponder and write about. How do you suggest we keep moving closer to the truth? Can we simultaneously personalize our minds, machines, and medicines to develop continuously? How? I am sharing a slide deck of thoughts to discuss meaning-making and the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the context of the post-truth world, which I collected to populate two invited lectures at the University of Minnesota, College of Pharmacy. The slides I am uploading here are in reverse order, 2nd lecture followed by the first. It is, to begin with, a journey to 2020+ to note that the root cause of BAD-I is I and to pose a challenging premise that beyond the age of majority, few adults continue to develop and mature. What evidence warrants this premise, and why? Then how to develop and mature continuously as an adult and a professional.
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We live in a post-truth world, and we like to think we are good. Are we? Do we not need ALCOA for the integrity of our experience?
Remember: Experience means to feel; how you feel determines what you learn! Honoring my grandmother’s advice, keeping intentions clean, इरादों को साफ रखें to begin to recognize a pattern of interactions between how I feel, what I think to explain why I behaved in a certain way.
Some of my thoughts on SMART Objective negotiations and to be better at SMART Experiencing than SMART Machines. The content describes insights from observing the immaturity of political, regulating, and management systems. Why does “immature” claim “I am mature” when it shouldn't?
I-SMART Internal Validation for Continuous Professional Development.pdfAjaz Hussain
i-SMART: Internal validation [is] continuous [professional development]. It is a journey within and without. In the growing chaos, it is urgent and essential that we must be the change we seek in the world. Be I-SMART! #Validaiton #good
S.M.A.R.T Pharmaceuticals 2021 -2030: AI or Human?Ajaz Hussain
Take a smart “development stance” to prepare for 2022 and beyond, envision your journey to 2030. Spiral high and wide like a migratory bird. Recall, Reflect, Research, Remember, Reset and Rebuild: Recycling necessary but not sufficient.
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The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
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Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
Embracing GenAI - A Strategic ImperativePeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Re-thinking Pharmaceutical Technology Continuing Education in the Context of Pharmaceutical Quality for the 21st Century
1. 9/13/2017 1
Ajaz S. Hussain, Ph.D., President
The National Institute for Pharmaceutical Technology & Education, Inc.
2. My interest and viewpoints
• My interest
• Make high pharmaceutical quality (i.e., assurance) affordable
and globally available
• My viewpoints
• Pharmacy & Pharmaceutical Science
• Academic (Ohio Northern University & University of Cincinnati)
• US FDA – SUPACs, IVIVC, BCS, PAT and Pharmaceutical Quality for the 21st
Century 1.0
• Sandoz/Novartis – Biosimilars and Complex Generics
• Philip Morris International – Plant based vaccines, iQOS® -
Modified Risk Tobacco Product
• Wockhardt – Biosimilars and Complex Generics
• Insight, Advice & Solutions LLC
• NIPTE Our knowledge pyramid topples easily!
9/13/2017 2
Also note – Advisor (pro bono) to the USP on PCM
3. I wonder,
seriously
• Does working in some of the current
GXP regulated environments impede
adult human development?
9/13/2017 3
4. I seek to understandstages of adult
development in the context of PQS; individual &
corporate
• What dangers he/she “knows” to be present that causes
him/her anxiety?
• CEO: Loosing access to market, delay in accessing
markets, …..
• FDA leaders: The next “Heparin Tragedy”,…….
• Head of R&D: Delay in clinical trial, missing the “filing
date”,…..
• QC Analyst: The next Out of Specification (OOS)
observation, the next Inspection
• FDA Investigator: High rate of invalidated OOS ,
Cheating by Design,….
• How change leaves him/her feeling defenseless or “In over
his/her head”?
• How it all relates to his/her know-how-what-why and
to his/her stage of development – Looking Good,
Being Good, Doing Good…..
9/13/2017 4
Life-cycle of a pharmaceutical professional
Looking Good
Being Good
Doing Good
Procrustes
6. Contribute to efforts seeking to fill epistemological gaps in our knowledge and create a
professional design space within which our practices prevent Procrustes within us to
surface and all have opportunity to achieve a higher order of consciousness.
9/13/2017 6
Design Space
Procrustes
Epistemology
Then and now?
7. Quality?
An elephant in
the dark! Not Six
Blind[folded]
Men and the
Elephant
9/13/2017 7
If each of us held a candle there, and if we went in together, we could see it - Rumi.
8. 21 CFR 211.25: Not on a solid
theoretical foundation! Nor can it
be expected to have a rich practice
experience.
• The only source of knowledge is experience.
• Rational behavior requires theory. Reactive
behavior requires only reflex action.
• We're blind to our blindness. We have very
little idea of how little we know. We're not
designed to know how little we know.
• What we mean by maturity in people's
thinking is not a matter of how smart they are,
but it is a matter of the order of consciousness
in which they exercise their smartness or their
lack of it.
9/13/2017 8
Einstein, Deming, Kahneman, Kegan
9. Leading
Indicators:
Cause the
Desired
Effect
9/13/2017 9
Double-blind, placebo controlled clinical trials – the “Gold Standard”
Quality predominantly confounded in clinical trial information!
Why not require a double-blind, placebo controlled QC testing system?
Oh, that is silly! Is it?
10. NIPTE 2017 Conference
In partnership with the USP
9/13/2017 10
NIPTE Pharmaceutical Education Mission
Center of Excellence - Pharmaceutical Education &
Certification Roadmap Integration
11. USP Pharmaceutical Education Programs for
Compendial Standards
USP Quality Standards
for Biologics
Excipients Up-to-Date
– the Importance of
Stakeholder
Engagement with USP
Pharmaceutical
Education at US
Pharmacopeia
12. Pharmaceutical Education Needs and Ways to
Improve the Impact of NIPTE’s contributions
Pharmaceutical
Certification Rationale and
Structure: Purdue
University Model
Evolving Industry Trends:
Science-Based Education
Distance Masters and PhD
Program at The University
of Kansas
Training of FDA Reviewers:
Lessons Learned and
Future Perspective
Industry Training in QbD:
Lessons Learned and
Future Perspective
Perspective: Generic
Industry
Perspective: Brand Industry
Pedagogy: Knowledge
Framework, Relating
Science and Engineering to
Development, Assessment
of Competences
[Best] Practices in
Pharmaceutical Education
NIPTE Certification in
Pharmaceutical Science
Pharmaceutical Education:
Priorities, [Best]Practices,
Sustainability
Certification: Explicit and
Implicit Value
Methods of Delivery;
“Flipped” Course
13. A wish; that we change the we think about -
Best, Good and Emerging Practices
Regulation of pharmaceutical quality is based on the assumption
that the processes contained within it are complicated (i.e.,
predictable, for a set defined starting conditions) so that Good
Practices such as defined Operational Routines (SOPs) and Project
Management are sufficient to reliably deliver the desired output.
Occasional errors (nothing is perfect) are quickly detected,
understood, corrected and prevented.
• Best; for simple systems that do not require any sophisticated attention
to education, training and experience
• Good; for complicated systems that require sophisticated attention to
education, training and experience
• Emerging; for complex systems that are not reliably predictable due to
multiple interactions and non-linearities
9/13/2017 13
14. Key points
• One Quality Voice @ FDA, USP, Industry and Academia
Priorities
• To the patients.
• Performance based standards that promote development of
pharmaceutical professionals and the Pharmaceutical Quality SystemValue
• Educational offering : Fundamentals and Specialized
• Stand-alone system for Assessment (Certification)Delivery
1
15. On an
average day
in the USA
91 people die from an opioid-related overdose (CDC
National Vital Statistics System)
Across the country, people like Riha are going in to fill
prescriptions only to discover that the cost has
doubled, tripled and in some cases soared by 1,000
percent or more (AARP)
In recent years, shortages of all sorts of drugs —
anesthetics, painkillers, antibiotics, cancer treatments
— have become the new normal in American
medicine. The American Society of Health-System
Pharmacists currently lists inadequate supplies of
more than 150 drugs and therapeutics, for reasons
ranging from manufacturing problems to federal
safety crackdowns to drug-makers abandoning low-
profit products. (NY Times)
9/13/2017 15
1
16. The engine of Affordability in the USA:
Current State (July-August 2017)
1
With U.S.
Generic Drug
Market in Chaos,
Indian Upstarts
Rise
2
Generic price
increased …..
reduced
manufacturer
counts
3
Market .. small
revenue .. supply
… duopoly or
monopoly in
recent years
4
FDA to boost
generic approval
to help
consumers lower
their .. costs
5
Maintain FDA’s
gold standard
for rigorous,
science-based
regulation
Assurance
a concern
Affordability
decreased
Availability +
Affordability
at Risk
One Quality Voice?
Prevailing “blind-spots”?
Increased complexity
increased uncertainty
19. Pharmaceutical Quality for the
21st Century 2.0.
• The future of pharmaceutical
quality is six sigma – 3.4 dpm!
• Path to get there- economic
drivers, performance-
based regulation, Quality by
Design, advanced manufacturing
technologies, continuous
improvement and operational
excellence.
• Six-sigma is rarely seen in the
pharmaceutical sector
External Failure: Class I Recalls
Lawrence X. Yu and Michael Kopcha
International Journal of Pharmaceutics 2017
9/13/2017 19
Note: All recalls > 7000 in just the 2007-2012 period
21. How the “Pill Ghost” and the
Procrustean Legacy maintains
our immunity to change?
• Under a shadow; the Generic Drug
Scandal - decisions of Judge Wolin –
left a lasting imprint on the “C” in
CGMP
• In the US; CMC reviewers pushed
back on considering Pharmaceutical
Development Report – “Black Art”!
• Then, what is critical? or Risk?
remained uncertain; everything is
critical and risky – paralysis!
• Increasing material and performance
complexity, increased concern on
controls and generalizability of
SUPAC – defaults (10X, 3-batches,….)
• Regulatory decisions without state-
of-art “pharmaceutical technology”
knowledge became untenable
9/13/2017 21
22. The legendary quote –still a good summary of the
current state of affairs; good news is that few
exceptions have emerged – such as Amgen!
•“We are a six sigma sector
with 2-3 sigma processes!”
• This was then and as it is now –
The Little Secret (WSJ 3
September 2003)
9/13/2017
22
Note: The author has no association with Amgen.
23. Amgen’s journey to six sigma – 3.4 dpm: The Background
9/13/2017 23
Martin VanTrieste, R.Ph CAPA within the Pharmaceutical Quality System, ICH Q10 Conference; October 4-6, 2011 – Arlington, Virginia
24. If I don’t look there is no problem!
9/13/2017 24
Martin VanTrieste, R. Ph. Improving the Quality of Investigations. PIA Meeting – June 21, 2012
25. From – “If I do not look there is no problem”
to “We are here to serve patients”
The critical question leaders at Amgen
posed - Why are Investigations
Important? Their answer - Stuff
Happens! They decided to leave
behind a mindset – If I do not look
there is no problem - and began their
journey with a reaffirmation “We are
here to serve patients.”
By 2010 – error rates reduced 90%, scrap
reduced 54%, disposition cycle time reduced
54%, and 65% of the manufacturing process
and product parameters were at six sigma.
By end of 2014, 82% of parameters are
performing at six sigma, 14% at 3-6 sigma
and 4% had CAPA open to improving
performance; cost savings cumulated (over
$ 300 million).
26. If I don’t look there
is no problem –
Problem-solving -
Prevention of errors
9/13/2017
26
Stages of Development
Individuals and Corporations
28. Order
Mindset – Leadership -
Regulatory Context
Cognitive Intrapersonal Interpersonal
3rd
Socialized; Leader:
Ineffective; FDA
Approved – All Okay
Know and follow the
rules, seek support
Are we OK?
Mend
relationships
4th
Self-authored;
Leader: Effective; FDA
Approved – but we are
responsible for quality
Problem-solving,
systems orientation
Did I achieve my
goals?
Follow a process;
methodology
5th
Self-transforming;
Leader: Exceptional;
“Our quality standards”
better than the
minimal requirements.
Explore options,
prevention of problems;
system of systems
Did I achieve a
valued outcome?
Value and learn
from the conflict
Stages of adult human development – the Orders of Consciousness (Kegan)
9/13/2017 28
4th Order; Self-authored (in every job, line-worker to CEO)
and problem solving know-how – needed for effective PQS!
29. The Amgen’s Journey (Biotech)
• Analytical characterization of raw materials, manufacturing
processes, and products; not just in the development
phase but also, as needed, in the commercial setting
• Will of the management and their involvement to identify,
track and control variation via process capability
assessment
• Continually monitoring to ensuring robust analytical
methods, manufacturing processes, and products (e.g.,
using industry benchmark for analytical variability and
decreasing assay variability; relevant to Invalidated OOS
Rate discussion to follow)
• Training, Qualification, Certification and Mentoring
support to ensure flawless execution, and
• Focus on supply chain controls and confidence.
9/13/2017 29
Connect to the Pharmaceutical Quality for the 21st Century 2.0.
Economic drivers, Performance-based regulation –
We must simultaneously achieve
Availability, Availability & Assurance and
ensure similar or equivalent performance
improvement in the Biosimilar and Generic
sector.
30. How I wish we would
organize our multiple
cognitive processes?
Remember Einstein’s
challenge that we will
never solve the problems
tomorrow with the same
order of consciousness we
are using to create the
problems of today!
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32. PQS Enablers & Elements: Link GDP to GMP over 5P Life-cycle
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Root-cause of many
OOS issues are often
built in R&D and CMC
Review!
Cognitive biases
Knowledge illusion
Business model: File
first – figure it out
later!
FDA Approved,
Validated – often
reasons for
rationalization!
33. Recognize how adults and corporations mature (or not)
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Recognize that a critical mass of 4+ Order Consciousness (at FDA and in industry)
necessary for effective PQS & Performance-based regulation
Warning Letters, Import Alerts
File first figure out with CMC review staff
- Multiple Review Cycles
Management-based regulations
2nd
3rd
4th
Per CMC reviewer demands
Per CMC reviewer demands
Science based & Risk assessed
34. Synthesis Across
Three Dimensions &
align and link to solutions and tools in HR Systems
(e.g., operational excellence tools industry uses)
• Cognitive competencies involve thinking,
reasoning, and related skills
• Intrapersonal competencies involve self-
management and the ability to regulate
one’s behavior and emotions to reach goals
• Interpersonal competencies involve
expressing information to others as well as
interpreting others’ messages and
responding appropriately
• Professional development stages looking-Good,
being-Good, to doing-Good to Good; in the context
of GXP’s and how these relate to societal needs.
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In the Context of
Pharmaceutical Quality for the 21st Century
Supporting pharmaceutical professional’s success.
2
3
4 5
35. Building on the 2016 initiatives
with a 2020 Vision
• Build on experience and lessons
from NIPTE-Sun Pharma Module 1
• Expanding collaboration beyond
FDA: USP and Industry
• New Prior Knowledge for
Availability, Affordability and
Assurance
• Credibility and business acumen –
“Third Leg of the Stool”
36. Looking forward to discussion @ NIPTE 2017
Anticipating a glimpse of a framework for:
21st Century Pedagogy
One Quality Voice , continually developing
professionals and improving PQS – in the
interest of patients and the next generation of
professionals.
A global [PT] education &
certification system for
individuals and corporation
seeking to achieving and
demonstrate:
One Quality Voice in the
context of PQS via “self-
authorship” relevant to their
current responsibility (front-
lines to CEOs) and future
growth aspirations and
benchmark their continual
development and improved
understanding and
capabilities to solve
contemporary problems.
General module – One
Quality Voice in the context
of PQS & Other Modules
Fundamental and advanced
levels
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37. Acknowledgment
The synthesis of Amgen’s journey discussed in this presentation was shared with Martin VanTrieste
(Chief Quality Office, retired, at Amgen) to ensure that my independent outside-view accurately
represented this journey. Martin graciously reviewed and confirmed its accuracy (7 August 2017).
Thank you! Martin suggested that it would be useful to add - on human performance - that a lot of
the system incorporated learning from systems used by the United States Nuclear Navy.
Also, please see: https://www.linkedin.com/pulse/break-2-3-sigma-barrier-biopharma-case-
example-ajaz-s-hussain-ph-d-/
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