COMMUNITIES OF INFORMATION, KNOWLEDGE & PRACTICE Some lessons learned, with PQRI and on to NIPTE Common characteristics build a “community of information” With common experience, a “community of knowledge” emerges For a “pre-competitive” community: “New Prior Knowledge” Why AAPS Mumbai Discussion Group can and should emerge as a Community of Knowledge? How? What (outcomes)? Today information is at our fingertips, and we are flooded with IT; urgent need a “community of knowledge” Information is “what,” knowledge is “how”, and wisdom is “why”: Insight (Why), Advise (How), Solution (What)

1. AAPS MUMBAI
DISCUSSION GROUP
PHARMACEUTICAL
COMMUNITY OF
KNOWLEDGE
AJAZ S. HUSSAIN, PH.D.
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2. COMMUNITIES OF INFORMATION,
KNOWLEDGE & PRACTICE
 Some lessons learned, starting with PQRI and on to NIPTE
 Common characteristics builds a “community of information”;
with common experience a “community of knowledge” emerges
 For a “pre-competitive” community: “New Prior Knowledge”
 Why AAPS Mumbai Discussion Group can and should emerge as
a Community of Knowledge? How?What (outcomes)?
 Today information is at our fingertips, and we are flooded with IT;
urgent need a “community of knowledge”
 Information is “what,” knowledge is “how”, and wisdom is “why”:
Insight (Why), Advise (How), Solution (What)
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3. “NEW PRIOR
KNOW>LEDGE” :
THREE “PRODUCT”
EXAMPLES
 Generic Enoxaparin Injection
 Generic Nasal Spray (Previous visit
to SciTech Center 15 October
2016)
 Levothyroxine Tablets
 Solve problems, application in
specific context of failure modes
 Failure modes: Patients, Product,
Process, Professional, and Profit
 Aggregated information,“connect-
the-dots” or synthesis,“totality of
evidence” that provides assurance
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4. WHEN IS INFORMATION TRANSFORMED
INTO “KNOWLEDGE”
 Sharing information by merely placing it in the public
domain is often insufficient until there is a need for the
information to solve a problem, and with application in
specific context, [then] information is transformed into
knowledge.
 New prior knowledge relevant for pharmaceutical product
development is, the aggregated information, in the context
of likely failure modes, that link the characteristics of the
drug substance to the physical-chemical to product
performance, therapeutic equivalence, and demands of
creating a manufacturable quality dosage form.
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5. PRODUCTS, PROCESSES,
PROFITS, PATIENTS,
PROFESSIONALS:
FAILURE MODES
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6. MULTIPLE SYSTEMS:
ECOLOGICAL (EVOLVED)
AND ENGINEERED
 Socio-economic-political system
 Public health system
 Disease care system
 Pharmaceutical system
 Corporate systems
 Professional system
 Education system
5 Whys 5 Whys 5 Whys 5 Whys
Corporate Regulators Politicians Professional Citizens
PQRI
NIPTE
AAPS
ISPE
PDA
USP, ASTM,..
ICH, Others
James Reason proposed the Swiss Cheese Model and Sakichi Toyoda, the 5 Whys technique
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7. 5 WHYS:TOO DIFFICULT TO ASK BROADLY
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8. INSURANCE IS UNAFFORDABLE WITHOUT
ADEQUATE ASSURANCE. Whereisthewisdomwehavelostin
knowledge?Whereistheknowledgewehavelostininformation? (Eliot)
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9. 5 WHYS:TOO DIFFICULT TO ASK UNDER CGMP “VALIDATED” STATE
Top Five Most Frequent 483 Citations recur year after year (Jerry Chapman, November 2018)
Responsibilities & Procedures for the QA Unit are not in writing or fully followed
Laboratory controls do not include the establishment of scientifically sound & appropriate
Failure to thoroughly review any/all unexplained discrepancy or failure of ….
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10. ARE WE ASKING THE “RIGHT” WHY QUESTIONS,AT
EACH LEVEL (OF A SYSTEM)?
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11. LET’S GO BACK TO
 11 November 2001: US FDA
Science Board Meeting
 Current state is untenable
 When standard deviation >
the mean it indicates Chaos
 Beyond average the system is
unpredictable
 The Butterfly Effect –
sensitivity to “starting
conditions” (dogmas, raw
materials and talent)
Data for brand companies, can generics “afford” such low efficiencies?
A causal factor for BAD-I!
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12. 8/5/2019AJAZ S. HUSSAIN | INSIGHT, ADVICE & SOLUTIONS 12

13. KNOWLEDGE HAS A
SOCIAL DIMENSION
 We can describe the why, how
and what of this social dimension
 Why: Social aspects influence
scientific inquiry (research) itself
 How: Social relations and values
effect research, and
 What: Desired effects on human
life and social relations
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14. “LAW IS ORDER”,AND
GOOD LAW MUST BE
SYSTEMS ORIENTED. BUT
LAWS NOT SUFFICIENTTO
ENSURE GOOD PRACTICES
 A system separates order from
disorder: Four systems
 Simple (cause & effect, self-evident:
“Best Practices”)
 Complicated (cause & effect
requires expertise;“Good
Practices”)
 Complex (cause & effect not
known, known in hind-sight; R&D)
 Chaotic (“Butterfly Effect”, extreme
sensitivity to starting conditions;
“line in the sand”, Jugaad,
Innovation)
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15. A BAD SYSTEMWILL
BEAT A GOOD PERSON
EVERY TIME (DEMING)
 Common cause strategy
(Deming)
 Common sense is not so common
(Voltaire)
 Common sense is the collection of
prejudices acquired by the age of
eighteen. (Einstein)
 Common sense is what tells us the
earth is flat (Stuart Chase)
 Many who are self-taught far
excel the doctors, masters,
and bachelors of the most
renowned universities (Ludwig
von Mise)
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16. The author is thankful toViveka Roychowdhury, Editor, and Express Pharma, for the kind permission to reproduce this picture from the
May 16, 2016, issue of the Express Pharma publication, Mumbai, India.
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17. AAPS MUMBAI
DISCUSSION GROUP
A“Communityof
Information”maturing
intoa“Communityof
Knowledge”
How? “Butterflyeffect”?
“Fractals”?
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18. ANSWERS TO WHY ARE
EXPLANATIONS, ARE OUTSIDE
THE SYSTEM, NEVER INSIDE IT!
(PROF. RUSSELL ACKOFF)
 Professional members/participants:
What should we do
 Management, administrators and
leaders: How do we doWhat we
should do
 Board of Directors, Advisors or
Mentors: Why how we do what we
should do
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19. SYSTEMS UNDERSTANDING IS A STAGE IN ADULT DEVELOPMENT
An intrapersonal (internal)
model for “Good Practice”
Our development occurs in multiple dimensions: Cognitive, Inter- and Intrapersonal proficiencies.
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20. A MODEL OF PHARMACEUTICAL QUALITY SYSTEM
ICHQ10GuidelineinEUandGuidanceintheUS:“CurrentThinking”.
AdoptedinEU2008,US2009,Japan2010,Canada2016
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21. GOOD PRACTICES & ORDER OF CONSCIOUSNESS:
PERSONALIZING PROFESSIONAL DEVELOPMENT [DIL SE]
Alice Y. Kolb and David A. Kolb. Learning Styles and Learning
Spaces: Enhancing Experiential Learning in Higher Education.
Academy of Management Learning & Education. 4: 193-212
(2005). https://www.jstor.org/stable/40214287
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22. THEVERB
‘EXPERIENCE’ IS
TO FEEL!!
Feeling,reflecting,thinkingand
acting–fourstagesofexperiential
learning.
Rememberweareinthe
“ExperienceEconomy”! Ifyouare
notfeelingyourEmotionsanAIIs!!
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23. EVENTS @ SCITECH CENTER: ADVISORY BOARD
 Prof. H.L. Bhalla
 Dr. Milind Biyani
 Mr.A.T. Borate
 Dr. (Mrs.) Parizad Elchidana
 Dr.Ajaz S Hussain
 Prof. (Dr.) Dwarkanath D. Kale
 Prof. Shunji Nagata
 Dr. Himadri Sen
 Dr.Vinod P. Shah
 Mr.Ajit Singh
 Dr.Amarjit Singh
 Mr. Jasjit Singh
 Prof. Clive G.Wilson
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Illustrative listing of “Communities of Information” @ different stages of evolution.

24. EVENTS @ SCITECH CENTER: FACILITATING EVOLUTION
 Problem-solving emphasized, 5 Whys
 Self-authorship opportunities for, and commitment by, participants
 Integrated programming to pair established and emerging experts
 Continual connectivity viaWeb for the SciTech Community
 Web based Q&A sessions and self-assessment and staging development
 Expectations (merit based) & satisfaction across the levels
 AAPS Mumbai Discussion Group take advantage to define its charter
to emerge as a Community of Knowledge
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25. BCP COMMUNITY @ AAPS, NIPTE COMMUNITY @ RUTGERS,..
PHARMACEUTICAL COMMUNITIES OF KNOWLEDGE:
Groups of individuals sharing a common identifying characteristic attentive to
generating caring for knowledge and to channel its power for good practices.
Only
because
Dil Se
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2004 2019

26. IF I COULD SEND A MESSAGE BACK INTIME:
CARE IS RESEARCH, KNOWLEDGE IS POWER,WISDOM IS IN PRACTICE
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