Published on February 8, 2014
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? 2/7/2014 AJAZ@AJAZHUSSAIN.COM 2
Current Situation: CGMP, India & USA 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? 2/7/2014 AJAZ@AJAZHUSSAIN.COM 3
Current Situation: CGMP, India & USA 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. 2/7/2014 AJAZ@AJAZHUSSAIN.COM 4
Integrity of data Survey question 1: A. Contemporaneous Key attributes of data quality necessary for assurance integrity? B. Accurate (select all correct answers) C. Attributable D. Original 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” 2/7/2014 AJAZ@AJAZHUSSAIN.COM 6
CAPA: Unacceptable to acceptable Past Behavior Future Behavior CAPA 2/7/2014 AJAZ@AJAZHUSSAIN.COM 7
Change in antecedents to past & current behavior? Past behavior: “…results failing specifications are retested until …” 2/7/2014 Attitude towards the behavior? Subjective norm? Perceived behavioral control? AJAZ@AJAZHUSSAIN.COM Current behavior: “…results failing specifications are retested until …” 8
Correcting past poor data integrity practices … High stakes Complexity Interrelated goals, large number of sub-tasks, high information density High risk (legal, reputational, financial..) at individual & organizational level Interdependence Pooled, sequential and reciprocal dependencies across the enterprise 2/7/2014 AJAZ@AJAZHUSSAIN.COM A useful analogy is the concept of ‘Risky Trust’ proposed by 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. 9
Building this – “Risky Trust” Trust Dimensions Antecedents Behaviors • Intentions • Competence, and • Process • Leader framing, • Team member interactional expertise, • Procedural transparency and impartiality • Monitoring behaviors (authorized peer pressure and continuous co-validation) • 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. 2/7/2014 AJAZ@AJAZHUSSAIN.COM 10
Three areas that need a added emphasis Trust dimension: Intentions 2/7/2014 Antecedents: Behaviors: Leader framing Learning behaviors (swift corrective action and adaptive problem solving) AJAZ@AJAZHUSSAIN.COM 11
Key challenges: Leader framing Leader framing ◦ Poor data integrity practices have been noted by US and UK regulators (the same observation were not necessarily noted by their Indian counterparts) ◦ From the US perspective - procedural adherence, documentation, and testing are critically necessary for assurance of product quality; not doing so results in the product to ‘adulterated’ ◦ In the Indian regulatory system word ‘adulterated’ is defined differently 2/7/2014 In a report (http://www.livemint.com/)dated 26 August 2013 the CEO of this Indian Company explained… “The meaning of the word adulterated was very different in the US compared to the dictionary meaning as understood by people or even as defined under the Indian Drugs and Cosmetics Act.” AJAZ@AJAZHUSSAIN.COM 12
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.” 2/7/2014 AJAZ@AJAZHUSSAIN.COM 13
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. 2/7/2014 AJAZ@AJAZHUSSAIN.COM 14
How about now? “….records are not completed contemporaneously” 2/7/2014 “…observed analyst back-date logbooks” AJAZ@AJAZHUSSAIN.COM Misguided or malicious 15
And now? “….records are not completed contemporaneously” 2/7/2014 “…observed analyst back-date logbooks” AJAZ@AJAZHUSSAIN.COM “appropriate controls not established.” Misguided or malicious 16
If observations are arranged in this sequence? “…appropriate controls not established….” 2/7/2014 “….records are not completed contemporane ously” “…over-writing electronic raw data…..” “…trial injections…..” AJAZ@AJAZHUSSAIN.COM “…results failing specifications are retested until acceptable results are obtained….” “…OOS not investigates per XYZ SOP” 17
Do you agree? Survey Question 2: “Jugaad, coupled with the attitude of “chalta-hai” in an environment that rewards absolute conformity to hierarchy and greed eventually leads to fraud.” Dinesh Thakur June 19, 2013. A. No B. Yes a. Shop-floor b. Supervisors c. Middle managers “Does India have cultural issues?” [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 2/7/2014 AJAZ@AJAZHUSSAIN.COM 18
Do you agree? Survey Question 3: “Scientists and operators were incentivized to act in a manner that produced results desired by the management by whatever means necessary.” Dinesh Thakur January 26, 2014 What % of companies you believe do so? A. 0% Caution – potential for a ‘framing effect” B. Less than 10% The range A (0%) - E (>30%) is arbitrary. C. Between 10 -20% Ensure the choice of this range does not influence your answer. D. Between 20 -30% E. More than 30% http://www.thehindubusinessline.com/opinion/our-propensity-for-jugaad-comes-in-the-way-of-developing-quality/article5620563.ece 2/7/2014 AJAZ@AJAZHUSSAIN.COM 19
We have already used terms such as… Intention [इरादा] Belief [विश्िास] Misguided [पथ से भटका हुआ] • a determination to act in a certain way • a state or habit of mind in which trust or confidence is placed in some person or thing • led or prompted by wrong or inappropriate motives or ideals Fraud [छल/कपट/धोखा ] • intentional perversion of truth in order to induce another to part with something of 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 2/7/2014 AJAZ@AJAZHUSSAIN.COM 20
Lets add a few more …. Behavior [बतााि] • the way a person or animal acts Perception [अनभि] ु • 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 others’ beliefs that he or she should or should not perform such behavior व्यक्ततपरक] Control [काबू में रहना] Misconduct [दराचार] ु • to have power over (something); to cause (something) to act or function in a certain way • To proceed objectively we need a precise definition…. http://www.merriam-webster.com http://www.shabdkosh.com 2/7/2014 AJAZ@AJAZHUSSAIN.COM 21
Behaviors and antecedents Past behavior Attitude towards behavior Subjective Norms Perceived behavioral control Intention Future behavior Shop-floor Attitude towards the behavior Supervisor usually found to predict behavioral intentions with a high degree of accuracy Subjective norm Intention Middle Management intentions, in combination with perceived behavioral control, can account for a considerable proportion of variance in behavior. Senior Management Shareholders Past Behavior Regulators (local) Future Behavior Regulators (aboard) Media Health care providers Patients 2/7/2014 Perceived behavioral control Ajen, I. The theory of planned behavior. ORGANIZATIONAL BEHAVIOR AND HUMAN DECISION PROCESSES 50, 179-211 (1991) AJAZ@AJAZHUSSAIN.COM 22
Based on recent media reports* would this be a useful representation? “chalta-hai” As noted in FDA 483 Juggad Please the supervisor Repeat of FDA 483 absolute conformity to hierarchy *see previous slide; Survey questions 2 & 3 2/7/2014 AJAZ@AJAZHUSSAIN.COM 23
I don’t entirely think so; why? Generalization to the sector would not be based on facts • There is generally high degree of professionalism and the recognition of proper context & cultural undertones conveyed by such terms Training & Empowerment • Of staff is certainly an aspect in need for attention More apt representation? • Would need to consider the element of ‘risk perception’ 2/7/2014 Attitude towards the behavior Past Behavior AJAZ@AJAZHUSSAIN.COM Subjective norm Risk Perception Intention Future Behavior Perceived behavioral control 24
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 2/7/2014 AJAZ@AJAZHUSSAIN.COM 25
[Non-malicious] Intention? perception that important others think that one should or should not.. the degree of positive negative evaluation of the behavior attitude toward performing the behavior unpleasantpleasant, unwisewise, bad-good, unnecessarynecessary,.. the subjective norm Validation is done so quality is good; documentation not critical; test prone to error "People who are important to me think I should do XYZ Supervisor would think batch failure is my mistake ALBARRACIN, JOHNSON, FISHBEIN, AND MUELLERLEILE Psychological Bulletin 2001, Vol. 127, No. 1, 142-161 2/7/2014 AJAZ@AJAZHUSSAIN.COM 26
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. 2/7/2014 AJAZ@AJAZHUSSAIN.COM 27
An additional influence? The focus is mainly on ensuring the final product meets tolerance zones. Subjective norms “The DCGI standards are lower but can we as a nation invest on each facility at par with USFDA standards?” “The almost doubling of costs is something we need to factor in.” Praful Akeli . Surabhi , Abantika Ghosh. Jan 28 2014 2/7/2014 AJAZ@AJAZHUSSAIN.COM the fact that facilities have failed to meet FDA standards does not necessarily mean the company's drugs are ineffective 28
Almost doubling of cost due to increase in? 2/7/2014 Training budget QA staff Cycle-time (to complete root-cause investigations) Batch rejection Doing it right should not add cost as projected Improved quality assurance Diminishes perception of domestic vs. export quality Pride and confidence Support India’s aspiration to be the ‘pharmacy to the world’ AJAZ@AJAZHUSSAIN.COM 29
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 2/7/2014 AJAZ@AJAZHUSSAIN.COM 30
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. 2/7/2014 AJAZ@AJAZHUSSAIN.COM 31
Current Situation: CGMP, India & USA 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. 2/7/2014 AJAZ@AJAZHUSSAIN.COM 32
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