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IDMA – UL SUMMIT 24 March 2015, Mumbai
"Evolving Quality Culture in Indian Pharmaceutical Industry“
Strengthening Our Cult...
February 25, 2005, Mumbai
The ISPE India- US FDA PAT
forum….
Sharing the stage with…
Dr. M. Venkateswarlu, Deputy
DCGI, an...
Organizational Culture, Good or Bad?
What can we learn from cases of
“Organizations Gone Wild”?* Normative
support for mis...
“And like the
heroes of the
French Revolution,
we look to a future
that will bring us
everything or
nothing, depending
on ...
 Indian Pharma & US Market Share
 2001 – 2014 CAGR 35% ; 15%
Volume Share
 “Pharmacy to the World“
 Relatively uniform...
To remain true to ‘first do no harm’ we, the
legitimate pharmaceutical community, have
inherited, and accepted, a culture ...
 1937
 1962
 1989
 2007
 2012
FD&C Act Kefauver-Harris
1984 Drug Price Competition
and Patent Term Restoration Act
FD...
Patients' trust in medicine and information
Trusting our ability as a reliable information provider
involves a reliance on...
“Generics is all about file first and figure out later” State
of QbD Implementation Report to FDA June 2010, Ted Fuhr,
Mck...
Staff Supervisors Sr. Mgmt.
R&D
Operations
Quality Unit Others
CEO
Company X: Normative support for Culture of Quality?
Ba...
Do these questions continue to linger in
Company X?
What is pharmaceutical quality?
Compendial testing sufficient?
Process...
3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 12
Practice, Control, Process: Maturity
Initial
• Unpredictable
Managed
• Characterized,
but reactive
Defined
• Characterized...
Maturity Level & Assurance of Quality
Managed Characterized,
but reactive
High risk of
‘Cheating by
Design’
“Trial
Injecti...
Risk of unintended or intended normative
support for ‘testing into compliance’?
attitude
toward
performing
the
behavior
Pr...
Patterns suggestive of ‘intentional holes’
3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 16
“….records not
...
3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 17
Organization (Policies
& Sr. Mgmt.)
Technology
(Constraint...
How would you
respond to this
statement? 15.21
9.9
14.1
17.5
43.4
At many Pharma companies
[in India] the staff would feel...
How would you respond to
this statement?
I think management should
urgently work towards
making error/mistake
reporting No...
Rationalization &
Attitude
Pressure &
Incentive
Opportunity –
‘holes in the QMS”
“The key to good
decision‐making is not
k...
Going beyond rules pays..
3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 21
3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 22
Culture of
Quality
Normal
Rewarding
Easy
QMS
System
Knowle...
Culture of Error गलती
Management प्रबंधन
What words would you use to
describe how you feel and
react to mistakes?
Your own...
Culture of Error Management प्रबंधन
• Error strain
• Covering up
Fear of Errors
X
• Anticipation
• Risk taking
Awareness
Y...
Two products; better than placebos
Culture of
Quality
Quality
by
Design
Good
[Manufacturing]
Practices
Quality
Management
...
“Both industry and the FDA need a culture of
quality” (see link to FDA website)
• Industry and the FDA have the shared
obl...
 Systems thinking: System is the product of interacting parts; improving the parts
taken separately will not improve the ...
9. Into a blind darkness they enter who follow after the Ignorance, they as if into a greater darkness who devote
themselv...
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QbD and CoQ IDMA Mumbai 24 March 2015 slideshare

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IDMA – UL SUMMIT 24 March 2015, Mumbai

"Evolving Quality Culture in Indian Pharmaceutical Industry“: Strengthening Our Culture of Quality

Organizational Culture, Good or Bad?

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QbD and CoQ IDMA Mumbai 24 March 2015 slideshare

  1. 1. IDMA – UL SUMMIT 24 March 2015, Mumbai "Evolving Quality Culture in Indian Pharmaceutical Industry“ Strengthening Our Culture of Quality Ajaz S. Hussain, Ph.D. Insight Advice & Solutions LLC National Institute for Pharmaceutical Technology & Education 3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 1
  2. 2. February 25, 2005, Mumbai The ISPE India- US FDA PAT forum…. Sharing the stage with… Dr. M. Venkateswarlu, Deputy DCGI, and Dr. S. P. Adeshara, Commissioner, FDCA Gujarat, .. 3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 2
  3. 3. Organizational Culture, Good or Bad? What can we learn from cases of “Organizations Gone Wild”?* Normative support for misconduct can occur in three main ways: Endorse it with varying degrees of explicitness (e.g., ADM) “Techniques of neutralization”; or a basis for rationalization (e.g., SB) Place a high value on achieving extraordinary performance (e.g., Enron) 1 2 3 *HENRICH R. GREVE, DONALD PALMER, and JO-ELLEN POZNER. Organizations Gone Wild: The Causes, Processes, and Consequences of Organizational Misconduct. The Academy of Management Annals Vol. 4, No. 1, (2010), 53–107 Also see: A Demon of Our Own Design QMS 3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 3
  4. 4. “And like the heroes of the French Revolution, we look to a future that will bring us everything or nothing, depending on the public trust”  The Nation Needs a Comprehensive Pharmaceutical Engineering Education and Research System  “A recent re-examination by the US Food and Drug Administration of the current pharmaceutical quality decision-making system raised fundamental questions about its efficiency and its continuing effectiveness to address the increasing complexity of pharmaceutical systems.”  “….low success rate for identifying the root cause of deviations and out-of-specification observations as well as the predominant focus on end-product testing—often based on an inadequate statistical consideration of inherent variability and static process conditions— which, some argue, evolved to facilitate regulatory document expectations for “process validation.” VIEWPOINT 2005 Pharmaceutical Technology SEPTEMBER 2005 3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 4
  5. 5.  Indian Pharma & US Market Share  2001 – 2014 CAGR 35% ; 15% Volume Share  “Pharmacy to the World“  Relatively uniform US FDA cGMP inspection findings for about a decade; recently a cluster of ‘breaches in data integrity‘  Is all of this rational? Is India being tageted for its success?  Today increasingly common understanding and commitment to work collaboratively  Culture of Quality  In the USA: 21st Centrury Initiative  Shortages, several deaths/ injuries from contaminated imported and domestc products, generic product recalls,.......  Erroding confidence, new laws, FDA funding to “test“ quality of generic products, OPQ/CDEREvolving Context: Culture of Quality is a ‘hot’ topic 3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 5
  6. 6. To remain true to ‘first do no harm’ we, the legitimate pharmaceutical community, have inherited, and accepted, a culture of quality that demands that our intention, our awareness and our skills deliver ‘quality by design’ with continued vigilance to detect, correct and to prevent errors that have caused, or have the potential to cause, harm to the patients we serve. We also recognize the limitations of our pharmacovigilance. We must more clearly recognize that CAPA is not ‘continual improvement’ and that we must strengthen our culture of quality to deliver continual improvement in our ability to assure quality, reduce costs and enhance confidence in what we do. Ajaz S. Hussain, Ph.D., Mumbai, 24 March 2015 VIEWPOINT 2015 3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 6
  7. 7.  1937  1962  1989  2007  2012 FD&C Act Kefauver-Harris 1984 Drug Price Competition and Patent Term Restoration Act FDASIA ………………. A partial, historical, ‘snap-shot’ of the US FD&C Act Proactive risk classification & mitigation needed 3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 7
  8. 8. Patients' trust in medicine and information Trusting our ability as a reliable information provider involves a reliance on us having the right attitude towards the possible consequences of our epistemic work. Torsten Wilholt. Epistemic Trust in Science. Br J Philos Sci (2013) 64 (2): 233-253 3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 8
  9. 9. “Generics is all about file first and figure out later” State of QbD Implementation Report to FDA June 2010, Ted Fuhr, Mckinsey& Company “It would also mean the FDA had no power to deny tentative approval to an application that clearly could never win final approval - an applicant could state in its ANDA that it planned to manufacture a generic drug in an outhouse behind the applicant's house using a child's chemistry set.“ U.S. District Judge Beryl Howell (March 11, 2015) 3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 9
  10. 10. Staff Supervisors Sr. Mgmt. R&D Operations Quality Unit Others CEO Company X: Normative support for Culture of Quality? Baddi Mumbai 3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 10
  11. 11. Do these questions continue to linger in Company X? What is pharmaceutical quality? Compendial testing sufficient? Process validation – representative of commercial manufacturing? Any deviation from cGMP means the product is ‘adulterated’? 3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 11
  12. 12. 3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 12
  13. 13. Practice, Control, Process: Maturity Initial • Unpredictable Managed • Characterized, but reactive Defined • Characterized; proactive Measured & Controlled • In control Optimizing • Focus on improvement 3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 13 Capability Maturity Model Integration; Carnegie Mellon University A validated process?
  14. 14. Maturity Level & Assurance of Quality Managed Characterized, but reactive High risk of ‘Cheating by Design’ “Trial Injections” “Testing in to Compliance” Defined Characterized; proactive Lower level of assurance Stopping & Correcting Batch Rejection Measured & Controlled In control Quality by Design Quality Assured Improvement Opportunities 3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 14
  15. 15. Risk of unintended or intended normative support for ‘testing into compliance’? attitude toward performing the behavior Process validation is done so quality is good; test prone to error “Batch failure means I made a mistake” subjective norm Documents not critical; Compendial testing sufficient Local regulators collect & test samples – no issue there! 3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 15 “Testing into compliance”
  16. 16. Patterns suggestive of ‘intentional holes’ 3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 16 “….records not completed contemporaneously” “…observed analyst back-date logbooks” “…trial injections…..” “…results failing specifications are retested until acceptable results are obtained….” “…over-writing electronic raw data…..” “…OOS not investigates per XYZ SOP” “…appropriate controls not established….” Each additional observation adds reasons to confirm that this is very likely a system with intentional ‘holes’ in its defenses.
  17. 17. 3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 17 Organization (Policies & Sr. Mgmt.) Technology (Constraints & Controls) Individual (Training & Certification) Team & Supervisor (Soft Defenses) Defenses (Quality Management System) Error Latent अप्रकट conditions Goal conflicts & mixed messages Design flaws Production pressures Fear of error “WE CANNOT CHANGE THE HUMAN CONDITION. BUT…WE CAN CHANGE THE CONDITIONS UNDER WHICH HUMANS WORK” JAMES REASON
  18. 18. How would you respond to this statement? 15.21 9.9 14.1 17.5 43.4 At many Pharma companies [in India] the staff would feel afraid to question a supervisor’s order even when they know for sure that the supervisor’s order is not in the interest of patients. 3/24/2015 Ajaz S. Hussain | Insight Advice & Solutions LLC 18 I disagree with this statement I completely agree with this statement N=263 Skipped = 0
  19. 19. How would you respond to this statement? I think management should urgently work towards making error/mistake reporting Normal, Easy and Rewarding. 5.8 6.6 17.4 32.8 31.54 3/24/2015 Ajaz S. Hussain | Insight Advice & Solutions LLC 19 It is already easy – so this is not urgent. It is very difficult currently so this is very urgent topic N=259 Skipped =4
  20. 20. Rationalization & Attitude Pressure & Incentive Opportunity – ‘holes in the QMS” “The key to good decision‐making is not knowledge, it is understanding. We are swimming in the former. We are desperately lacking in the latter” ‐ Malcolm Gladwell 3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 20
  21. 21. Going beyond rules pays.. 3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 21
  22. 22. 3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 22 Culture of Quality Normal Rewarding Easy QMS System Knowledge Variation Behavior Behavior - GXPs Fear Removed Mastery Awareness Environment Leadership Emphasis Message Credibility Peer Involvement Employee Empowerment Connect to CoQ Connect to GXPs A Framework and a Tool (for gap analysis)
  23. 23. Culture of Error गलती Management प्रबंधन What words would you use to describe how you feel and react to mistakes? Your own, of a co-worker, of a subordinate. How does your supervisor react? 3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 23 Picture purchased from www.pixtastock.com
  24. 24. Culture of Error Management प्रबंधन • Error strain • Covering up Fear of Errors X • Anticipation • Risk taking Awareness Y • Development QbD/RFT • Error detection, Communication • Analyzing errors, Correction Mastery orientation Z 3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 24
  25. 25. Two products; better than placebos Culture of Quality Quality by Design Good [Manufacturing] Practices Quality Management System 3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 25 Immediate Attention: Management responsibilities – leadership emphasis and message credibility to remove even a perception of normative support for cGMP deviations; reduce fear Effective training, coaching and mentoring: System, design and statistical thinking; Culture of quality training Setting the ‘right specification’ Effective root-cause investigations and CAPA; improve logic and communication Change current regulatory requirements for post- approval supplements to facilitate effective CAPA
  26. 26. “Both industry and the FDA need a culture of quality” (see link to FDA website) • Industry and the FDA have the shared obligation to reduce quality errors and provide high quality medications to the American public. • To fulfill this responsibility, both industry and the FDA need a culture of quality. • A true quality culture is an environment in which the entire organization not only follows quality guidelines but also is focused on continuous improvement. • It is important to recognize that financial incentives don’t always reduce errors. • Employees must be passionate about eliminating mistakes and making quality their driving principle. 3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 26
  27. 27.  Systems thinking: System is the product of interacting parts; improving the parts taken separately will not improve the system CEO & Sr. Management Culture of Quality Managers & Leaders Effective QMS GXP Compliance All Employees Quality is Easy 3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 27
  28. 28. 9. Into a blind darkness they enter who follow after the Ignorance, they as if into a greater darkness who devote themselves to the Knowledge alone. 10. Other, verily, it is said, is that which comes by the Knowledge, other that which comes by the Ignorance; this is the lore we have received from the wise who revealed That to our understanding. 11. He who knows That as both in one, the Knowledge and the Ignorance, by the Ignorance crosses beyond death and by the Knowledge enjoys Immortality Isha Upanishad: Knowledge and Ignorance, Verses 9 – 11 VIDYA AND AVIDYA VOLUME 17 THE COMPLETE WORKS OF SRI AUROBINDO (2003) The problem of reductionism: - it works for small, not for big steps - it misses the whole - it misses the meaning - in the end, it undercuts itself. Systems approach…… Note. I have take a different point of view from that of Dharm P. S. Bhawuk, Science of Culture and Culture of Science: Worldview and Choice of Conceptual Models & Methodology. The Social Engineer. Vol. 11, No. 2, July, 2008. Practicing to improve (awareness of) our intentions is our wisdom tradition, and is reflected in our laws, in US, India and around the globe… 3/24/2015 © Ajaz S. Hussain | Insight Advice & Solutions LLC 28

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