Culture of Quality - Ajaz Hussain

Dr. M. VenkatDr. M. Venkat

Indian Pharma Inc. : AIndian Pharma Inc. : A

[email protected]

June 2015 IPA Convention 20

teswarlu Memorial Lectuteswarlu Memorial Lectu

Culture of QualCulture of Qualdapting to the Rapidly Evolving Global Challedapting to the Rapidly Evolving Global Challe

015, BKC, Mumbai

Pharmacy to the World” isdiadiaPharmacy to the WorldPharmacy to the World

Strengthen Strengthen our culture our culture of qualityof quality

Health Care for All –Leadership in setting

the standards for Integrative Medicine, of qualityof qualityleveraging the Wisdom Traditions.

1144

Affordability - Patient f d i llO li d d

2233

focused, continually improving system

based on deep understanding &

integrating engineering &

One quality standard -‘Do No Harm’ to

‘Providing a Healing Touch’ – “India Pharma Brand Identity – Made

in India Proudly”


engineering & statistics.

in India, Proudly .

Pharmaceutical Factory to the WorldPharmaceutical Factory to the World

the right aspiration for

Purpose of this talk is to request you toPurpose of this talk is to request you toPurpose of this talk is to request you to Purpose of this talk is to request you to consider the following 4 Steps consider the following 4 Steps

•• Strengthening the ‘Culture of Quality’ Strengthening the ‘Culture of Quality’ –– the the f f thi t lkf f thi t lkfocus of this talkfocus of this talk

• Improve efficiency with confidence in controls by integrating India’s engineering and statistical know-how and technologiesknow how and technologies

• Working together – ‘One Quality for All’ to say proudly – Made in India: Pharmaceutical Factory Pharmaceutical Factory the Worldthe World

• Leverage India’s Wisdom Traditions to provide leadership in setting the standards for IntegrativeMedicine so as to deliver a model of ‘Health Carefor All’: Pharmacy to the WorldPharmacy to the World

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for All : Pharmacy to the WorldPharmacy to the World

actory of the world’ thenactory of the world then

India in 2020: the factory of the worldIndia in 2020: the factory of the world

• Ansuya Harjani | Wednesday, 3 Sep 2014;y j | y, p ;•http://www.cnbc.com/id/101966191

'It is now India's turn to sustain Asia's'It is now India's turn to sustain Asia's

• Narendra Modi | May 23, 2015•http://wap.business-standard.com/article/opinion/it-is-now-india-s-turn-to-susta

Pharmacy Vs. Factory - is there a diffePharmacy Vs. Factory - is there a diffe

• Journey to 2020 would benefit from clar


‘Pharmacy to the World’Pharmacy to the World

d? d?

; ;

success‘ success‘

ain-asia-s-success-115052300806_1.html

erence? YES.erence? YES.

ity of the vision

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ndia is set to become the020a Shivkumar, The Hindu, April 17, 2013

In the immediate – short term, until 2020, industrthe work force it needs to be the ‘pha

With 64 per cent of

the work-force it needs to be the pha

By 2020, India is set to become

the world’s t

With 64 per cent of its population in the working age group.

youngest country Median age in India

will be 29 years.

In parallel, a strong focus on institutional recoveryto be the ‘Pharmac


e youngest country by

y will need to take-on ‘skills development’ for armaceutical factory to the world’!armaceutical factory to the world !

• Institutional recoverwill have to be its topmost priority

• Quality of teachers a

The impact of The impact of institutional decay. institutional decay. Krishna Kumar, The Hindu, 15 • Quality of teachers a

all levelsSeptember 2014

y to excellence critical to realize the aspiration cy to the World’

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NDIA’S SCIENCE TEST V P d 14 MAY 2015 | VOL 521 | NATUREV. Padma, 14 MAY 2015 | VOL 521 | NATURE

h i i i h ih i i i h iThe Mars mission experience has once again strThe Mars mission experience has once again str

pharmacy of the developing world”pharmacy of the developing world”

…great strides in research and development…great strides in research and development, , bubu

Lack of even bare, minimal and sustainable funds for teachingLack of even bare, minimal and sustainable funds for teachingandards of science education,” andards of science education,” Krishna Ganesh, Director of the

Here [state universities], there are no good science teachers, nHere [state universities], there are no good science teachers, ne poorly equipped”e poorly equipped”

There is overThere is over--bureaucratization within the universitiesbureaucratization within the universities

WE ARE CAUGHT IN A VICIOUS CIRCLE OF MEDIOCRITY” WE ARE CAUGHT IN A VICIOUS CIRCLE OF MEDIOCRITY” - De

Often the appointed person has never been exposed tOften the appointed person has never been exposed tebastian, Chair of the science-education panel of the Indian Acade


h d b li f hh d b li f hrengthened our belief that we can.”rengthened our belief that we can.”

ut it has a long way to go.”ut it has a long way to go.”

g, let alone research, has seriously plagued the quality and g, let alone research, has seriously plagued the quality and Indian Institute of Science Education and Research in Pune.

no good Indian textbooks, and most of the science laboratorno good Indian textbooks, and most of the science laborator

s and their controlling bodies” s and their controlling bodies”

epak Pental, former vice-chancellor, the University of Delhi.

to a good university in India or abroad,” to a good university in India or abroad,” Kizhakeyilemy of Sciences in Bangalore.

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ackground: India Pharmaackground: India Pharma

The narrative on India The narrative on India Pharmaceutical SectorPharmaceutical Sector

20052005

Current stateCurrent state

Looking forward to 2020

Looking forward to 202020202020


Independence-2005: Independence-2005: pNonexistent to a World Leader

pNonexistent to a World Leader

l b l l l lGlobal sales: Value 1%, Volume 8%; ranking: 4 in volume, 13 in value

Continued growth and challenges to ‘Brand Identity’

What will ensure growth that justifies the claim of ‘Pharmacy

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to the World’?

ackground: 2005 a speciaackground: 2005 a specia


al yearal year

February 25, 2005, February 25, 2005, Mumbai Mumbai The The ISPE ISPE IndiaIndia-- US US FDA FDA PAT PAT forum….forum….

Sharing the stage Sharing the stage with…with…Dr MDr M VenkateswarluVenkateswarlu

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Dr. M. Dr. M. Venkateswarlu, Venkateswarlu, then Deputy DCGIthen Deputy DCGI

ackground: My viewpointackground: My viewpoint

ViewView

Building successful bgenerics, biosimila

Building successful bgenerics, biosimila

Reconnecting with IInd

Reconnecting with IInd

Way forward to Way forward to yy


on Culture of Qualityon Culture of Quality

point in 2005point in 2005

business models for complex ars, plant-based vaccines,..business models for complex ars, plant-based vaccines,..

India and current practice in dia: “Dil Se”India and current practice in dia: “Dil Se”

2020: Culture of Quality2020: Culture of QualityQ yQ y

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y Viewpoint in 2005: As ay Viewpoint in 2005: As a

With increased complexity the current approacp y ppssurance are untenable

Need a effective methodology for QbD and forgy Qust tests and SOP’s

ncorrect focus on compendial tests and their uction mode”; continual improvement unlikely

An integrated approach (e.g., PAT Team) to regi l iontinual improvement.

We must transform our education system fromi ingineering


a regulatora regulator

ch to development, manufacturing and qualityp , g q y

r a focus on in –process controls as opposed tp pp

use for lot-release keeps the system in ‘correctwithin this mindset.

ulatory oversight is necessary to move toward

m ‘Industrial Pharmacy’ to Pharmaceutical

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iewpoint 2005: As a reguliewpoint 2005: As a regulThe Nation Needs a CoPh i l E iVIEWPOINT 2005 Pharmaceutical EngineeResearch System

“A recent re‐examinationAdministration of the cur

VIEWPOINT 2005

fdecision‐making system rabout its efficiency andto address the increasinpharmaceutical systemp y“….low success rate foof deviations and out‐oas well as the predomintesting—often based ontesting often based onconsideration of inhereprocess conditions—wfacilitate regulatory documvalidation ”


validation.Pharmaceutical Technology SEPTEMBER 2005

atoratormprehensive i Ed i dering Education and

n by the US Food and Drug rrent pharmaceutical quality

“And like the heroes of the French Revolution, we look to a future

p q yraised fundamental questions d its continuing effectiveness ng complexity of ms.”

that will bring us everything or

nothing, depending on the public trust”

or identifying the root cause of‐specification observations nant focus on end‐product n an inadequate statisticaln an inadequate statistical ent variability and static which, some argue, evolved to ment expectations for “process

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005 onwards, amazing opewpoint 2015ewpoint 2015

VP & Global Head Biopharmaceutical Development, SandozVP & Global Head Biopharmaceutical Development, Sandoz

Biosimilars & complex generics

VP Next Generation Product Assessment and hen Chief Scientific Officer at Philip Morris

VP Next Generation Product Assessment and hen Chief Scientific Officer at Philip Morris pnternational

pnternational

Plant based vaccines & Modified Risk Tobacco Products

President Biotechnology & Chief Scientific Officer t Wockhardt Ltd

President Biotechnology & Chief Scientific Officer t Wockhardt Ltd

Understanding the aspirations opportunities and challengesUnderstanding the aspirations, opportunities and challenges in India


pportunities to expand my

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Way forward to 2020Way forward to 2020


Culture Culture of of QualityQuality

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What is Quality?What is Quality?


MMedicine made correctly whenedicine made correctly when

no one is lookingno one is lookingno one is looking.no one is looking.

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When is medicine When is medicine mademade correctly?correctly?made made correctly?correctly?


Our collective consensus, based on sciencOur collective consensus, based on sciencobjectively determines what are the good objectively determines what are the good practices practices –– capability, capacity and capability, capacity and commitment to practice when no one iscommitment to practice when no one iscommitment to practice when no one is commitment to practice when no one is looking.looking.

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When medicine isWhen medicine isWhen medicine is When medicine is not made not made correctly…correctly…


People People get sick. Some get sick. Some die. die. It is hard to It is hard to detectdetect harmharm Some of these people areSome of these people aredetect detect harm. harm. Some of these people are Some of these people are already very vulnerable, and proving the already very vulnerable, and proving the cause of harm from impurities, adulterationcause of harm from impurities, adulterationand counterfeits can be elusive. and counterfeits can be elusive. Congressman ShimkusCongressman Shimkus

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19891989

19371937

19621962

19891989

19371937

FD&C Act FD&C Act Kefauver-Harris Kefauver-Harris 1984 Drug Prand Patent Te1984 Drug Prand Patent Te

A partial, historical, ‘snap-shot’ of the US F


20122012

20072007Proactive risk Proactive risk

classification & classification & mitigation mitigation

needed needed

rice Competition erm Restoration Actrice Competition erm Restoration Act FDASIAFDASIA ……………….……………….

FD&C Act

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With increasing With increasing complexitycomplexitycomplexity…complexity…


Mistakes cost more lives. Path to success must be built on trustworthiness so as to proudly proclaim to the world we (a company) make the medicine you confidencompany) make the medicine you confidengive to your child!

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What is Culture What is Culture of of Quality?Quality?Quality?Quality?


Knowledge, beliefs, values, Knowledge, beliefs, values,

t diti b h i dt diti b h i d tititraditions, behaviors and traditions, behaviors and practices practices

that give confidence that medicine that give confidence that medicine

made made correctly when no one is correctly when no one is

looking.looking.

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When When no one is no one is ooking?ooking?ooking?ooking?


Our intention guides our Our intention guides our

behaviorbehaviorbehavior.behavior.

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We are humansWe are humans


Our thoughts and beliefs areOur thoughts and beliefs are

powerful and influence our

actions and also outcomes.

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Placebo effect:Placebo effect:Placebo effect: Placebo effect: A study A study ublished in 2015 “opens ublished in 2015 “opens our eyes to another our eyes to another uance of placebo effect with implications for uance of placebo effect with implications for inical practice the research enterprise andinical practice the research enterprise andinical practice, the research enterprise, and inical practice, the research enterprise, and ealth ealth policy”. policy”. Editorial Neurology 84: Editorial Neurology 84: 20152015


““perceptionsperceptions of cost are capabof cost are capabperceptions perceptions of cost are capabof cost are capab

of altering the placebo responsof altering the placebo respons

in clinical studiesin clinical studies.” .” Neurology 84: 20Neurology 84: 20

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lso, as humans lso, as humans “we “we cancanbvious, and we are alsobvious, and we are alsolindnesslindness.”.”

Daniel Kahneman,

Thinking, Fast and Slow


n be blind to the n be blind to the o blind to our o blind to our

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http://web.mit.edu/persci/people/adelson/checkershadow_proof.h

o these questions contio these questions contiompany Xompany X??ompany Xompany X??

What is pharmaceutical quality?

Compendial testing sufficient?

Process validation – representativ

Deviation from cGMP means the


inue to linger in inue to linger in

ve of commercial manufacturing?

product is ‘adulterated’?

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k of unintended or inten‘testing into compliance

Process validation is

done so quality is

dattitude toward

performing

good;

test prone to errorperforming

the behaviorerror

“Batch failure means I made a mistake”

“T ti i t li ”“T ti i t li ”

/14/2015 CONFIDENTIAL – ©INSIGHT ADVICE &

“Testing into compliance”“Testing into compliance”

nded normative supportppe’?

Documennot critic

subjective norm

Compendtestingnorm g

sufficien

Local regulatoregulato

collect & tsamples –issue ther

””

© AJAZ S. HUSSAIN | & SOLUTIONS LLC 2

””

Latent Latent अूकट अूकट conditions conditions

Fear of errorFear of error

Design flawsDesign flaws

Techno

ErrorError

(Constra

“We cannot change the human condition. Bhumans work” James Reason


humans work James Reason

Goal conflicts & mixed messagesGoal conflicts & mixed messagesProduction pressuresProduction pressuresProduction pressuresProduction pressures

O i iOrganization (Policies & Sr. Mgmt.)

Team & Supervisor (Soft Defenses)

ology

Individual (Training & Certification)

DefensesDefenses(Quality Management System)(Quality Management System)

aints & Controls)

But…we can change the conditions under which

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H ldH ldHow would you How would you respond to this respond to this t t t?t t t?statement?statement?

At many Pharma companiesAt many Pharma companiesAt many Pharma companies At many Pharma companies in India] in India] the the staff would feel staff would feel

afraid to question afraid to question a a upervisor’supervisor’s order even whenorder even whenupervisor’s upervisor’s order even when order even when hey know hey know for sure for sure that the that the upervisor’s order is not in upervisor’s order is not in the the t tt t f ti tf ti tnterest nterest of patients.of patients.

I cwi


I disagree with this statement

15.21

9.943.4 N=263Skipped = 0

14.1

17 517.5

completely agree ith this statement

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ow would you ow would you respond respond this statement? this statement?

think management think management houldhould urgently workurgently workhould hould urgently work urgently work owards making owards making rror/mistakerror/mistakerror/mistakerror/mistakeeporting eporting ormal, Easy and ormal, Easy and ewarding.ewarding.

It isthi


this

It is already easy soIt is already easy – so this is not urgent.

5.86.6

[VALUE]

17.4

[VALUE]

N=259Skipped =4

32.8

s very difficult currently so i t t i

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s is very urgent topic

redictors of CoQ: Act consatients – when no one is latients when no one is l

Leadership Emphasis

Only four attributes

ll d

Only four attributes

ll d

Message Credibility

actually predict a culture of

quality:

actually predict a culture of

quality: Peer Involvement

Employee Empowerment


sciously in the interest of ookingooking.

N l (1)

People will change their

b h f h

People will change their

b h f h

Normal (1)

behavior if they see the new behavior as

behavior if they see the new behavior as

Easy (2)

Rewarding (3)

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simple framework for CoQsimple framework for CoQ

EnvironmentEnvironment Leadership EmphasisLeadership Emphasis Message CredMessage Cred

Culture of

Normal

Easy QMSQuality

Rewarding

Q

Dem


& Ja

QQ

dibilitydibility Peer InvolvementPeer Involvement Employee EmpowermentEmployee Empowerment

Systemy

KnowledgeBehavior

GXPs

Fear Removed

Mastery

Variation

Behavior

- GXPs

Awarenes

ming’s Profound Knowledge

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g games Reasons – Human Factors

Systems thinking: System is the product of ink t l ill t i th t aken separately will not improve the system

Quality Quality

CEO & Managers & All


Sr. Management Leaders Employees

nteracting parts; improving the parts

is Easy is Easy

Culture Effective GXP

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of QualityQMSCompliance

June 2015 IPA Convention 20015, BKC, Mumbai 3

Not so highly Not so highly regulated”regulated”gg

Export qualityExport qualityp q yp q y

Highly regulated” Highly regulated” g y gg y g


“Pharmacy to the World”“Pharmacy to the World”

Domestic qualityDomestic quality

St d d Hi hlSt d d Hi hlStandard = Highly Standard = Highly

RegulatedRegulatedRegulated Regulated

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llopathy: Export quality =llopathy: Export quality

f not - why should any one believe that,ooking, quality is delivered as promised

The argument – that “affordabilitylit t d d i k i d fquality standards is weak, indefen

from the aspiration to be “pharma

Commitment to a single quahumans – is a measure of cu


Domestic qualityDomestic quality

, when no one is ?

y” demands two ibl d t ksible and takes away

acy to the world”.

ality standard – we are all ulture of quality.

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ince 2000 organizations beceived the most Demingeceived the most Deming

0

5

Deming Prizes since 2000http://blog.deming.org/2014/10/2014-deming-prize-awardees/

5

0

5

0

0


based in India have PrizesPrizesWhat does it take to win the “Deming Prize”?

•Commitment to Total Quality Management•The foundation is total employee involvement!

• Attrition rates 25-50%; primarily in QC/QA departments; why? Is the fear level so high?

Where are we today in India Pharma?

• How effective is their training in college? At the company? How effective are supervisors in coaching and mentoring techniques?

• How effective are the HR systems to mitigate the effects of “Saala main to sahab ban gaya” attitudes in someSaala main to sahab ban gaya attitudes in some supervisors and senior management?

• Why 483 Observations are often not shared with the employees?

• How many Sr. Management truly understand what is quality

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How many Sr. Management truly understand what is quality – and are their messages credible?

mpower professionals, give tdia the ‘pharmacy to the wordia the pharmacy to the wor

There is amazing taleThere is amazing tale

Urgent need for moreUrgent need for moreU ge t eed o o ementoring – to removU ge t eed o o ementoring – to remov

Within India, but outs“quality revolution” inclass quality’ is right

Within India, but outs“quality revolution” inclass quality’ is rightclass quality is right class quality is right


them the challenge to make rld’; slogans will not do itrld ; slogans will not do it.

ent & commitment to hard work ent & commitment to hard work

e effective training, coaching and e effective training, coaching and e e ect e t a g, coac g a dve fear and to empowere e ect e t a g, coac g a dve fear and to empower

side Pharma, there is an ongoing n some sectors; knowhow for ‘world here

side Pharma, there is an ongoing n some sectors; knowhow for ‘world herehere here

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nowhow for ‘world class qnowhow for world class q


quality’ is right herequality is right here

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iewpoint 2015 “Dil Se”iewpoint 2015 Dil Se

VIEWPOINT 2015


To remain true to ‘first do no harm’ we, the legitimate pharmaceutical community havelegitimate 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 thepatients we serve. We also recognize the limitations of our pharmacovigilance.

We must more clearly recognize that CAPA is not ‘continual improvement’ and that wenot 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 fid i h t d

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confidence in what we do. Ajaz S. Hussain, Ph.D., Mumbai, 24 March 2015

iewpoint 2015 “Dil Se” toiewpoint 2015 Dil Se to

In the immediateIn the immediate –– short term ushort term uIn the immediate In the immediate short term, ushort term, uto taketo take--on ‘skills development’ foon ‘skills development’ fobe the ‘pharmaceutical factory tobe the ‘pharmaceutical factory top yp y

In parallel, a strong focus onIn parallel, a strong focus onexcellence critical to realize texcellence critical to realize texcellence critical to realize texcellence critical to realize t‘Pharmacy to the World’!‘Pharmacy to the World’!


SolutionsSolutions

ntil 2020 industry will needntil 2020 industry will needntil 2020, industry will need ntil 2020, industry will need or the workor the work--force it needs to force it needs to o the world’! o the world’!

institutional recovery to institutional recovery to the aspiration to be thethe aspiration to be thethe aspiration to be the the aspiration to be the

015, BKC, Mumbai 3

rmacy to the World”: A champion forrmacy to the World”: A champion for

Health Care for All –

Pharmacy to the WorldPharmacy to the World 11

Strengthen Strengthen our culture our culture of qualityof quality

Health Care for All Leadership in setting the standards for Integrative Medicine, leveraging the

Wisdom Traditions.

11

2233

44

Affordability - Patient focused, continually

improving system based

One quality standard -‘Do No Harm’ to

‘Providing a Healing

2233

improving system based on deep understanding

& integrating engineering & statistics.

Providing a Healing Touch’ – “India Pharma

Brand Identity – Made in India, Proudly”.

Pharmaceutical Factory to the WorldPharmaceutical Factory to the World


yy

•• Leadership emphasisLeadership emphasis

ReRe--shaping the Environmentshaping the Environment

p pp p•• Message credibilityMessage credibility•• Peer involvementPeer involvement•• Employee empowermentEmployee empowerment

•• Quality is normalQuality is normal•• Quality is easyQuality is easy

ReRe--setting the Normssetting the Norms

•• Quality is rewardingQuality is rewarding

Commitment to the SystemCommitment to the System

Ensuring effective QMSEnsuring effective QMS

•• Commitment to the SystemCommitment to the System•• Knowledge basedKnowledge based•• Understanding & controlling variationsUnderstanding & controlling variations•• SafeSafe--guard human error; pride of workmanshipguard human error; pride of workmanship

•• Fear removedFear removed•• MasteryMastery

Promoting proactive behaviorsPromoting proactive behaviors

015, BKC, Mumbai 3

MasteryMastery•• Awareness Awareness

Documents

Culture of Quality - Ajaz Hussain