Dataintegrity 140207203534 Phpapp01

Data In teg ri ty ÷ ÷ ÷
AJAZ S. HUSSAIN, PH.D.| INSIGHT, ADVICE & SOLUTIONS LLC
2/7/2014 AJAZ@AJAZHUSSAIN.COM 1
Current Situation: CGMP, India & USA
Poor data integrity practices noted by US FDA &
UK’s MHRA at several companies in India
• Remediation poses several challenges. How to understand why?
It has bee alleged that “Chalta-Hai” attitude etc.,

are part of the cause…
• Understanding human behavior is critical . What may be the root cause of noted
‘cluster’ of challenges?
Both US and UK regulators have acknowledged
that many companies in India state-of-the art
• Reason for optimism. It is already happening.
Authorities in India have expressed displeasure on

the notion of dual standards
• Signal standard will take time . How to move in this direction and create a win-win
opportunity?
Suspicion of ‘political and business interest’ raise
the possibility of unease in bilateral relations
• Appreciating differences in each others needs. Opportunities at hand to improve

affordability.
It is time to turn the corner by getting to the root

cause and work to fill the divide
• Delivering affordable high quality for all - Training, technology and trust.
Integrity of data
Survey question 1: A. Contemporaneous
Key attributes of B. Accurate

data quality
necessary for
assurance C. Attributable
integrity?
D. Original
(select all correct
answers)
E. Long-lasting
An illustrative list of observations (FDA 483)
During inspection of your firm we observed
• “…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….”
• “….records are not completed contemporaneously”
• “…observed analyst back-date logbooks”
CAPA: Unacceptable to acceptable
Past Future
Behavior Behavior
CAPA
Change in antecedents to past & current
behavior?
Attitude
towards the
Past behavior? Current
behavior: behavior:
“…results Subjective “…results
failing norm? failing
specifications specifications
are retested are retested
until …” Perceived until …”
behavioral
control?
Correcting past poor data integrity
practices …
Complexity High stakes
High risk (legal,
Interrelated goals,
reputational,
large number of
financial..) at
sub-tasks, high
individual &
information density
organizational level
Interdependence
Pooled, sequential
and reciprocal A useful analogy is the concept of ‘Risky Trust’
dependencies proposed by Faaiza Rashid and Amy C.
across the
enterprise Edmondson. Risky Trust: How Multi-entity Teams
Develop Trust in a High Risk Endeavor . Working
Paper 11-089. 2011, Harvard Business School.
Building this – “Risky Trust”
• Intentions
Trust Dimensions • Competence, and
• Process
• Leader framing,
Antecedents • Team member interactional expertise,
• Procedural transparency and impartiality
• Monitoring behaviors (authorized peer pressure and

continuous co-validation)
Behaviors • Learning behaviors (swift corrective action and adaptive
problem solving)
Faaiza Rashid and Amy C. Edmondson. Risky Trust: How Multi-entity Teams Develop Trust in a High Risk Endeavor . Working Paper 11-089. 2011, Harvard Business School.
Three areas that need a added emphasis
Trust
Antecedents: Behaviors:
dimension:
Learning
behaviors (swift
Intentions Leader framing corrective action
and adaptive
problem solving)
Key challenges: Leader framing
Leader framing In a report (http://www.livemint.com/)dated 26
◦ Poor data integrity practices have been noted by August 2013 the CEO of this Indian
US and UK regulators (the same observation
were not necessarily noted by their Indian Company explained…
counterparts)
◦ From the US perspective - procedural
adherence, documentation, and testing are “The meaning of the word adulterated was
critically necessary for assurance of product very different in the US compared to the
quality; not doing so results in the product to dictionary meaning as understood by people
‘adulterated’ or even as defined under the Indian Drugs and
◦ In the Indian regulatory system word Cosmetics Act.”
‘adulterated’ is defined differently
Drug Manufacturing Focus: Why India?
Siegfried Schmitt. PHARMACEUTICAL TECHNOLOGY. Volume 37, Issue 12, pp. 58 (Dec 2, 2013).
“Though there is no denying that data-handling irregularities have been

detected, there has not always been a malicious intention behind them.”
“In several cases, there has been a misguided belief that data should look good.
However, such data manipulation or data invention still constitutes fraud,

irrespective of a person’s intention.”
Would you give the benefit of doubt* and
categorize this observation as an misguided?
Misguided
“….records are not

completed
contemporaneously”
Malicious
*Sometimes the desire to have visually clean (without smudges)

records can be the explanation; but the body language - fear and
stress of an inspection – conveys the opposite impression.
How about now?
“….records are not

“…observed analyst Misguided or
completed
back-date logbooks” malicious
contemporaneously”
And now?
“….records are
“…observed “appropriate
not completed Misguided or
analyst back-date controls not
contempor- malicious
logbooks” established.”
aneously”
If observations are arranged in this
sequence?
“…OOS not
investigates
“…results per XYZ SOP”
failing
“…trial specifications
injections…..” are retested
“…over-writing until
electronic raw acceptable
“….records are data…..” results are
not completed obtained….”
“…appropriate contemporane
controls not ously”
established….”
Do you agree?
Survey Question 2:
A. No
“Jugaad, coupled with the attitude of
“chalta-hai” in an environment that
rewards absolute conformity to B. Yes a. Shop-floor
hierarchy and greed eventually leads
to fraud.” Dinesh Thakur June 19, b. Supervisors
2013.
“Does India have cultural issues?” c. Middle managers
[compliance with US FDA
requirements] d. Senior management
e. All levels
http://www.thehindubusinessline.com/opinion/our-propensity-for-jugaad-comes-in-the-way-of-developing-quality/article5620563.ece
Do you agree?
Survey Question 3: What % of companies you believe do so?
“Scientists and
operators were A. 0%
incentivized to act Caution – potential for a
in a manner that ‘framing effect”
produced results B. Less than 10%
desired by the The range A (0%) - E (>30%)
management by C. Between 10 -20% is arbitrary.
whatever means
necessary.” Ensure the choice of this
D. Between 20 -30% range does not influence
Dinesh Thakur
January 26, 2014 your answer.
E. More than 30%
http://www.thehindubusinessline.com/opinion/our-propensity-for-jugaad-comes-in-the-way-of-developing-quality/article5620563.ece
We have already used terms such as…
Intention [इरादा] • a determination to act in a certain way
Belief [विश्िास] • a state or habit of mind in which trust or confidence is placed in some person or thing
Misguided [पथ से भटका हुआ] • led or prompted by wrong or inappropriate motives or ideals
• intentional perversion of truth in order to induce another to part with something of

Fraud [छल/कपट/धोखा ] value
“Chalta-hai” [चलता है ]
• literal translation ‘it moves’ - often expresses an attitude of ignoring rules because
of a belief that they are not important (“it will do”)
“Juggad” [जुग्गद] • a frugal solution or innovation (with a undertone of disregarding rules)
http://www.merriam-webster.com
http://www.shabdkosh.com
Lets add a few more ….
Behavior [बतााि] • the way a person or animal acts
Perception [अनभ
ु ि]
• the way you think about or understand someone or something; the ability
to understand or notice something easily
Subjective norm [आत्मननष्ठ, • an individual’s perception of social normative pressures, or relevant

व्यक्ततपरक] others’ beliefs that he or she should or should not perform such behavior
Control [काबू में रहना]

• to have power over (something); to cause (something) to act or function
in a certain way
Misconduct [दरु ाचार] • To proceed objectively we need a precise definition….
http://www.merriam-webster.com
http://www.shabdkosh.com
Behaviors and antecedents
Attitude towards Perceived behavioral
Past behavior Subjective Norms Intention Future behavior
behavior control
Shop-floor
Supervisor Attitude towards usually found to predict behavioral intentions, in combination with
the behavior intentions with a high degree of perceived behavioral control, can
accuracy account for a considerable proportion of
Middle Management variance in behavior.
Senior Management
Shareholders Past Future

Behavior Subjective norm Intention
Behavior
Regulators (local)
Regulators (aboard)
Media
Perceived
behavioral control
Health care providers
Ajen, I. The theory of planned behavior. ORGANIZATIONAL BEHAVIOR AND HUMAN DECISION PROCESSES 50, 179-211 (1991)
Patients
Based on recent media reports* would
this be a useful representation?
“chalta-hai”
As noted in Please the Repeat of FDA

Juggad
FDA 483 supervisor 483
absolute
conformity to
hierarchy
*see previous slide; Survey questions 2 & 3
I don’t entirely think so; why?
Generalization • There is generally high degree of
to the sector professionalism and the recognition Risk
would not be of proper context & cultural Attitude Perception
undertones conveyed by such terms towards the
based on facts behavior
Training & • Of staff is certainly an aspect in need

Past Subjective Future
Empowerment for attention Behavior Intention
norm Behavior
More apt • Would need to consider the element Perceived

behavioral
representation? of ‘risk perception’ control
Then what may be the root cause of
noted ‘cluster’ of challenges?
Although there are similarities in poor data integrity practices noted across several
companies specific root-causes would need to be investigated based on facts on ground
As noted previously (Siegfried Schmitt, December 2013) - there has not always been a
malicious intent and there are misguided beliefs; these point to a need to further evaluate
the attitudes and subjective norms in this context to ensure effective corrections
Clearly, like any where else, the possibility of malicious intent needs to be thoroughly
investigated and appropriately disciplined not just by the organization but broadly;
mechanisms for the letter (e.g., as available to the US FDA) are not apparent today
[Non-malicious] Intention?
perception that
the degree of important others
positive negative think that one
evaluation of the should or should
behavior not..
unpleasant- "People who are

attitude toward pleasant, unwise- the subjective important to me
performing the wise, bad-good, think I should do
behavior unnecessary- norm
XYZ
necessary,..
Validation is done
so quality is good; Supervisor would
documentation not think batch failure
critical; test prone is my mistake
to error
ALBARRACIN, JOHNSON, FISHBEIN, AND MUELLERLEILE Psychological Bulletin 2001, Vol. 127, No. 1, 142-161
It is often not understood that
Compendial standard (testing) is applicable to “units tested”
USP General Notices: 34th Revision: The similarity to statistical procedures

may seem to suggest an intent to make inference to some larger group of
units, but in all cases, statements about whether the compendial
standard is met apply only to the units tested. Repeats, replicates,
statistical rejection of outliers, or extrapolations of results to larger
populations, as well as the necessity and appropriate frequency of batch
testing, are neither specified nor proscribed by the compendia.
An additional influence?
The focus is mainly on
ensuring the final product
meets tolerance zones.
the fact that

“The DCGI standards are facilities have failed
Subjective lower but can we as a
nation invest on each
to meet FDA
standards does not
norms facility at par with USFDA
standards?”
necessarily mean
the company's drugs
are ineffective
“The almost doubling of
costs is something we need
to factor in.” Praful Akeli .
Surabhi , Abantika Ghosh.
Jan 28 2014
Almost doubling of cost due to increase
in?
Doing it right should not add cost
as projected
QA staff
root-cause investigations)
Batch rejection
Cycle-time (to complete
Training budget
Improved quality assurance
Diminishes perception of
domestic vs. export quality
Pride and confidence
Support India’s aspiration to be

the ‘pharmacy to the world’
US FDA is actively addressing these
challenges
India has a tremendous opportunity to lead with existing center of excellence
Many companies in India have already moved forward
Quality by Design
• Punjab University has won the AAPS QbD Awards
Technological improvements
• IIT’s and NIPER
Clear path forward must be win-win
If I follow US standards, I will have to shut almost all drug facilities:
G N Singh. Interview with Drug Controller General of India. Sushmi
Dey January 30, 2014
We are going to insist that they don’t have any dual standards for
international and Indian markets,” G N Singh, Drugs Controller
General of India. Aesha Datta. January 27, 2014.
Suspicion of ‘political and business interest’ raise
the possibility of unease in bilateral relations
• Appreciating differences in each others needs. Opportunities at hand to improve

affordability.
It is time to turn the corner by getting to the root

cause and work to fill the divide
• Delivering affordable high quality for all - Training, technology and trust.

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Data In teg ri ty ÷ ÷ ÷

AJAZ S. HUSSAIN, PH.D.| INSIGHT, ADVICE & SOLUTIONS LLC

• Remediation poses several challenges. How to understand why?

It has bee alleged that “Chalta-Hai” attitude etc.,

• Reason for optimism. It is already happening.

Authorities in India have expressed displeasure on

• Appreciating differences in each others needs. Opportunities at hand to improve

It is time to turn the corner by getting to the root

Key attributes of B. Accurate

• Monitoring behaviors (authorized peer pressure and

“Though there is no denying that data-handling irregularities have been

However, such data manipulation or data invention still constitutes fraud,

“….records are not

*Sometimes the desire to have visually clean (without smudges)

“….records are not

• intentional perversion of truth in order to induce another to part with something of

“Juggad” [जुग्गद] • a frugal solution or innovation (with a undertone of disregarding rules)

Subjective norm [आत्मननष्ठ, • an individual’s perception of social normative pressures, or relevant

Control [काबू में रहना]

Misconduct [दरु ाचार] • To proceed objectively we need a precise definition….

Shareholders Past Future

As noted in Please the Repeat of FDA

Training & • Of staff is certainly an aspect in need

More apt • Would need to consider the element Perceived

unpleasant- "People who are

USP General Notices: 34th Revision: The similarity to statistical procedures

the fact that

Cycle-time (to complete

Pride and confidence

Support India’s aspiration to be

Many companies in India have already moved forward

• Appreciating differences in each others needs. Opportunities at hand to improve

It is time to turn the corner by getting to the root

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