2. SGC2
in complying to increased Regulatory expectations.
Current Challenges to Industry
3. 3
Frequent questions asked at the time of
review & inspections
âś“Product design
âś“Critical quality attributes
âś“Critical material attributes
âś“Critical process parameters
âś“Lack of clear rationale behind setting specification
âś“Minimal justifications on scale up process
Moving towards Process & Product
understanding……
4. 4
String of warning letters has put Pharma industry into microscopic scrutiny of regulators-especially
in India.
Major findings…
➢Data Integrity.
➢Inadequate investigations,
➢Inadequate laboratory systems,
➢Repeat issues due to improper implementation of CAPA
or identification of root cause.
Questions in the minds of regulators-
âś“ Do they investigate to improve knowledge or simply build arguments for release of product?
âś“ Reactive rather than proactive usage of knowledge!
âś“ Is company learning organization?
âś“ Above all Integrity of the organization is at question.
In addition last decade…….
5. 5
In the words of Ms. Janet Woodcock, MD, Director, CDER,
USFDA…
“ Key lessons that could mitigate current Pharmaceutical Quality
issues such as avoiding a shame and blame game and denial of
collective responsibility”
In conclusion she said.. “Reliable drug quality occurring when
organization and industry look beyond just compliance and start
moving towards Culture of Quality”
(PDA/FDA joint conference,WashingtonDC, September,2013).
USFDA thoughts on this situation-
6. 6
Quality Culture
Quality in a Person arises
from a concern for
excellence in Quality
Sustainability Achieved
through robust Quality
Systems
Always CGMP
Complaint
Company
Moving towards Perfection
Excellence in
Operation Excellence in
Quality
Development or
improvement of
mind by education
& training
QUALITY SYSTEMS-PRACTICAL
ROADMAP
TO SUSTAINABLE QUALITY CULTURE
7. 7
QUALITY SYSTEMS-PRACTICAL ROADMAP
Leading to Excellence
The Quality Culture: Focus on Continuous Improvement.
:Work beyond just compliance.
The Quality Guru Mr. Philip.B.Crosby said "Quality is Free"
i.e. cost of prevention is much less than correction and remedial costs.
Quality costs are broadly classified as below...
➢ Prevention Cost (design, auditing, training etc).
➢ Appraisal Cost (inspection and testing).
➢ Internal Failure Cost (scrap, reprocess, rework).
➢ External Failure Costs (complaints. Recalls, also stoppage of business due to
import alert from regulatory authorities).
Investment in prevention i.e. is robust Quality Systems and developed culture of
Quality will reduce failure costs.
8. 8
Quality Culture.
➢Quality Culture is a feature of Organizational design
that fosters cross functional ownership of Quality.
It treats Quality is not hindrance for success, but as necessity that
allows the company to make decisions that best benefits patients.
➢Culture determines Quality outcomes.
➢A healthy quality culture requires management ownership and
accountability, performance metrics that promote continual
improvement and a strong risk management frame work.
9. 9
Quality Culture.
Culture of Quality creates an environment needed to
facilitate every individual to guide his/her own
behaviour to work in the interest of patients and to
continually improve this ability.
Creating a Culture of Quality: Financial incentives don’t
reduce errors. Employees must be passionate about
eliminating mistakes.
Quality Culture is doing right things when no body is looking
at you.
11. Product life cycle: ICH Q10
Pharmaceutical Development
Commercial Manufacturing
Product Discontinuation
Technology Transfer
• Drug substance development
• Formulation development
• Manufacture IMP
• Delivery development
• Manuf. process development
• Scale up
• Analytical method development
• New product transfer
• Transfer marketed product between &
within Manuf. & Test sites
• Acquisition & control material
• Facilities provision
• Utilities & Equipment provision
• Production
• QC & QA
• Release
•Storage & Distribution
• Retention of documents
• Sample retention
• Continued product assessment and
reporting
Validation
• Equipment
• Analytical method
• Process
• Cleaning validation
11
12. 12
âś“ Achieves Product Realization
* “Delivery of products with the quality attributes appropriate to
â–Ş Meet the needs of patients
â–Ş Health care professionals
▪ Regulatory authorities ”
âś“ Establishes and Maintains a State of Control
* “Effective monitoring and control systems for process performance and product quality”
âś“ Facilitate Continual Improvement
* “implement, appropriate product quality improvements, process improvements, variability
reduction, innovations and pharmaceutical quality system enhancements”
âś“ Enablers
* Knowledge Management
* Quality Risk Management
Objectives - ICH Q10
13. 13
âś“ Knowledge Management
*Product and process knowledge should be managed from
development through the commercial life of the product up to and
including product discontinuation
âś“ Quality Risk Management
* Quality risk management is integral to an
effective pharmaceutical quality system
* Proactive approach to identifying, scientifically
evaluating and controlling potential risks to quality
Objectives - ICH Q10
14. SGC14
Quality Policy.
Quality Manual.
Quality Planning.
Participate in design, implementation &
monitoring of
Pharmaceutical Quality System (PQS)
Define individual & collective roles &
responsibility.
Organizational structure /independent Quality unit.
Effective Resource Management.
Management Responsibility.
15. 15
Conduct Management Reviews.
Advocate continual improvement.
Communication.
Flow of appropriate information between all
levels of the company.
Ensure the escalation of product quality issues to
appropriate level of management.
Oversight of outsourced activities.
Supplier, Contractor- manufacturing &
analysis.
Management Responsibility.
16. 16
*Elements.
âś“Process Performance and Product Quality Monitoring.
âś“Corrective Action & Preventive Action (CAPA).
âś“Change Management System.
âś“Management Review of Process Performance and
Product Quality.
ICH Q10
Pharmaceutical Quality Systems (PQS).
17. SGC17
Tools for Measurement.
Data management &
Statistical tools.
Use of QRM for
control strategy
Identify source of
Variation.
Strategy to control or
reduce variation
Feedback on Product
Quality. Complaints,
Rejection, deviation , audits
& regulatory Inspection
findings.
Knowledge Management to
Enhance Process & Product understanding
Process Performance and Product Quality
Monitoring.
18. 18
Corrective actions resulting from Investigations
of Complaints, Rejections, non-conformances,
Recalls, Deviations, Audit & Regulatory
Inspection findings.
Preventive Action resulting from trends from
process performance & product quality
monitoring.
CAPA enhances process & product knowledge, supports continual
improvement.
Monitor Effectiveness of CAPA.(Knowledge Management).
Corrective Action & Preventive Action (CAPA)
19. 19
Use QRM to evaluate change.
Impact Analysis.
R&D, Production. Quality,
Regulatory &Engineering.
Change is Scientifically
Justified.
Assess impact on Regulatory
Submission.
Change Management to ensure Continual Improvement helps in…
Knowledge Management
Change Management System.
20. 20
The results of Regulatory inspections
external & internal audits.
Quality Reviews.
Measures customer satisfaction- complaints &
recalls.
Conclusion on process performance
& product Quality monitoring –APQR.
Effectiveness of process and product changes. Change
control & CAPA.
Management Review of Process
Performance and Product Quality.
21. 21
Improvements to manufacturing process &
products.
Provision, training and/or realignment of
resources.
Capture and dissemination of knowledge.
Management Review is important tool for Continual
Improvement of the Pharmaceutical Quality System.
Management Review of Process
Performance and Product Quality.
22. 22
QUALITY CULTURE.
Six Dimensions of Cultural Excellence Framework
1. Building Capability.
2. Corporate Culture.
3. Business Continuity Planning.
4. Robust Quality Systems.
5. Quality Metrics.
6. Communication - Communication within the Organisation.
Communication with Customer.
Communication with Vendors.
Communication with Regulatory authorities.
(Basis: ISPE project report, 2015).
23. 23
QUALITY CULTURE: Building Capability
The capability of the organisation depends on
➢ Quality Culture,
➢ Robust Quality Systems,
➢ Right Organisational Capability
➢ Effective supply chain partnerships.
The organisational capability includes..
âś“ Effective leadership and Management.
âś“ Sufficient resources at all levels to meet work demands.
âś“ Defined organisation structure.
âś“ Clear definition of roles and responsibilities.
âś“ Decision making and accountability at each level of organisation.
âś“ Skills and training to enable effective decision making and fulfil roles and
responsibilities.
âś“ Effective engagement with supply chain partners.
24. 24
QUALITY CULTURE: Building Capability
Effective Leadership…
✓ Defined Goals aligned with Company’s strategies and plan.
âś“ Motivate Resources to take right decision.
âś“ Communication across the organisation.
âś“ Promote Integrity and Transparency at all levels.
Skill development and training is core focus on capability building. Other than
on job and CGMP training using Subject Matter Experts (SMEs), Mentoring
and coaching (by leaders and peers) is important part of capability
development.
Knowledge Management: product and process knowledge should be managed
throughout the product life cycle through robust quality systems.
25. 25
QUALITY CULTURE: Corporate Culture.
Corporate Culture is driven by leadership and plays key role in sustainable quality
culture.
âś“ Leaders establishing the vision for the organisation through leading by example
(Walk the Talk).
âś“ Engage the employee at all levels to understand the attitude & mind-set.
âś“ Assessing and coaching using Gemba Walks. (Shop floor rounds, understand the
real issues and get inputs from operators, resolve issues, use this walk for
mentoring).
âś“ Ongoing monitoring using key triggers and leading indicators of Quality.
âś“ Oversight, reporting and review by learning leaders. Proactive approach to
understand the status, resolve issues and drive resources to improvement.
âś“ Building capability is structural enabler for healthy culture. Learning organisation
development, developing proactive problem solving skill by training and
development.
26. 26
QUALITY CULTURE: Business Continuity Planning.
âś“ Achieve robustness in supply chain management with robust Quality
System.
âś“ Build redundancy. Assess the process and operation, identify and
evaluate, plan for additional capacity, a backup facility, second supplier,
additional inventory, in case of contract manufacturer additional customer
etc.
âś“ Establish resiliency: Crisis management plan.
âś“ Develop facility response plans: these will restore operations if event
occurs.
27. 27
QUALITY CULTURE: Robust Quality System.
• Effective implementation of ICH Q10 Pharmaceutical Quality System in
conjunction with...
âś“ ICH Q8. Pharmaceutical Development.
âś“ ICH Q9. Quality Risk Management.
âś“ ICH Q11. Development and Manufacture of Drug Substance.
is the key to the success.
• The Quality Policy, Quality Manual, and various elements of quality systems
should be implemented throughout the product life cycle.
• The implementation of Quality systems should trigger Knowledge Management
and facilitate continual improvement.
28. Process Development
Stage-2: Process Qualification
Qualification Batches
Process scale up / Q-Lots Stage-1: Process design
Process Validation
Commercial Manufacturing
Change Management
CAPA
Annual Product review
Stage-3: Process Verification
Technology Transfer
Changes
Changes
Changes
Changes
Knowledge Management through Product life cycle
28
30. 30
QUALITY CULTURE: Communication
➢Communication within the Organisation.
➢Communication with Customer.
➢Communication with Vendors.
➢Communication with Regulatory authorities.
This will create transparency in the organisation and high level of
corporate culture is achieved.
31. 31
Quality Culture leads to Excellence.
➢Six elements which will lead to Cultural Excellence.
1. Leadership and Vision.
2. Mindset and Attitudes.
3. Gemba Walk.
4. Leading Quality Indicators and Triggers.
5. Oversight and Reporting.
6. Cultural Enablers.
Holistic assessment of these elements required to foster, develop, monitor,
measure, learn and ultimately improve an organization’s Quality Culture.
This is a cycle , learning goes back to this elements and it continues.
32. 32
Quality Culture leads to Excellence.
Leadership and Vision.
5V Model Leader.
➢Vision – Quality vision, strategy, Unifying goals, Plan Mantra –share
with entire organization.
➢Vigilance.- Accountability, Follow through etc.
➢Visibility- Presence/ Gemba Walks, Priority actions and reactions.
➢Voice- Passion, Credibility, Clarity, Motivation.
➢Values- Ethics, Model Behaviors, Humility
Leader should lead by example, able to coach and mentor his team and
helps to build learning organization.
33. 33
Quality Culture leads to Excellence.
Mindset and Attitudes.
Culture is a way of thinking, behaving, or working that exists in a place or
organization.
Mindset performance loop has
Mindset Attitude Behavior Action
Performance Results
Mindset is established set of attitudes.
Attitude is a settled way of thinking or feeling about something.
Behavior is the way in which something or some one functions.
Leaders can influence the mindset and attitudes by mentoring by providing positive
cultural experience (feed back from Gemba walks). This needs time and commitment.
34. 34
Quality Culture leads to Excellence.
Gemba.
Gemba means “actual place” (Japanese term).
Gemba walks demonstrates visible commitment from the leadership to all
employees.
Crucial for continual improvement, best way to engage the frontline in problem
solving, understanding real issues, …
Visibility of the leaders make difference in overall mindset.
Process of mentoring, a way to empower operator and analysts, building/
enhancing capabilities and giving due recognition.
Opportunity for operators to show their performance and share their thoughts on
process and environment. Also leader to communicate the vision priorities.
It is not an audit or trouble shooting exercise.
35. 35
Quality Culture leads to Excellence.
Leading Quality Indicators and Triggers.
➢A Leading Indicator is proactive situation on the basis of knowledge
before process begins or error occurs.
➢ A Lagging indicator is reactive situation. It is the
measurement that indicates Result.
In addition to various quality triggers such as deviation, OOT,OOS, audit
observation etc, in the context of Quality Culture we should review
changes in behavior that may relate to Quality issue.
â–Ş Antecedents triggers behaviors.
â–Ş Behaviors are followed by consequences.
â–Ş Consequences determine if behavior will reoccur.
36. 36
Quality Culture leads to Excellence.
Management Oversight and Review.
➢Aligned Quality Objectives.
Quality Dash board, Periodic reporting, Process mapping.
➢Monitoring for Continuous Improvement.
APQR, QMS trending, Quality Metrics, MRM
➢Leadership Involvement.
Gemba walks, MRM, Monitors and Continuously supports
Manufacturing and Quality Process
➢External Party oversight and reporting.
Product Quality, Audit Compliance, Contractual Compliance.
37. 37
Quality Culture leads to Excellence.
Cultural Enablers.
➢Learning Organization.
Learning from situation, Mentoring, Goal alignment, Communication.
➢Model behavior.
Leader demonstrates during Gemba walk.
➢People Recognition System.
Key Performance Indicators.
➢Identify and Recognize the change.
Through trends, QMS monitoring
➢True Root cause analysis with CAPA.
➢Continuous Problem Solving.
PDCA plan-do-ckeck-act.
38. 38
• Six dimensions of cultural excellence framework when
implemented leads to Proactive Quality Culture.
• The spirit of Continual Improvement becomes core agenda
of the organisation.
• Knowledge Management by effective implementation of
Quality System through out the product life cycle leads to
Excellence i.e.
Sustainable Quality Culture.
39. 39
“Quality (meaning getting everyone to do what they have
agreed to do) is the skeletal structure of an organization;
finance is the nourishment; and the relationship are the soul.
All of this comes together in what I call completeness”
Phillip. B. Crosby
(Quality Guru)
Completeness :Sustainable Quality Culture
40. 29-10-201940
*A strong quality culture is best indicated by what is done when
no one is looking.
*Culture is cornerstone of Quality.
*“Excellence is Continuous Process and not an accident"
- Dr. A.P.J Abdul Kalam.
41. 29-10-201941
1. ISPE Drug Shortages Assessment and Prevention
Tool document, 2015.
2. Quality Culture- Quarterly Report,
Pharmaceutical Engineering, October, 2015.
3. Cultural Excellence Report –ISPE,2017.
4. Creating Culture of Quality by Ashwin
Srinivasan and Bryan Kurey, Harvard Business
Review April, 2014.
5. ICH Q10 Pharmaceutical Quality System.
References:
