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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
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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*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
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.”
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
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
“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)
“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.
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
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.
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…