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 LLCNational Institute for Pharmaceutical
Technology & Education
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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, ..
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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)
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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
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“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
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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
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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
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1937
1962
1989
2007
2012
FD&C Act Kefauver-Harris 1984 Drug Price Competition
and Patent Term Restoration ActFDASIA ……………….
A partial, historical, ‘snap-shot’ of the US FD&C Act
Proactive risk classification &
mitigation needed
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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
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“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)
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Staff Supervisors Sr. Mgmt.
R&D
Operations
Quality Unit Others
CEO
Company X: Normative support for Culture of Quality?
Baddi
Mumbai
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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’?
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Practice, Control, Process: Maturity
Initial
• Unpredictable
Managed
• Characterized, but reactive
Defined
• Characterized; proactive
Measured & Controlled
• In control
Optimizing
• Focus on improvement
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Capability Maturity Model Integration; Carnegie Mellon University
A validated process?
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 controlQuality by
DesignQuality Assured
Improvement Opportunities
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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!
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“Testing into compliance”
Patterns suggestive of ‘intentional holes’
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“….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.
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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
How would you respond to this statement? 15.21
9.9
14.1
17.5
43.4At many Pharma companies [in India] the staff would feel afraid to question asupervisor’s order even when they know forsure that the supervisor’s order is not in theinterest of patients.
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I disagree with this statement
I completely agree with this statement
N=263Skipped = 0
How would you respond to this statement?
I think management should urgently work towards making error/mistakereporting Normal, Easy and Rewarding.
5.86.6
17.4
32.8
31.54
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It is already easy – so this is not urgent.
It is very difficult currently so this is very urgent topic
N=259Skipped =4
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
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Culture of Quality
Normal
Rewarding
Easy
QMS
System
Knowledge
Variation
Behavior
Behavior -GXPs
Fear Removed
Mastery
Awareness
EnvironmentLeadership Emphasis
Message Credibility Peer InvolvementEmployee
Empowerment
Connect to CoQ
Connect to GXPs
A Framework and a Tool (for gap analysis)
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?
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Picture purchased from www.pixtastock.com
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
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Two products; better than placebos
Culture of Quality
Quality by
Design
Good [Manufacturing]
Practices
Quality Management
System
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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
“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.
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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
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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…
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