QUALITY MANAGEMENT

IN PHARMACEUTICAL INDUSTRY

Wayan Redja
2018

Fakultas Farmasi Universitas Pancasila

Jakarta
 QUALITY MANAGEMENT
IN PHARMACEUTICAL INDUSTRY

MID SEMESTER FINAL SEMESTER

 QUALITY MANAGEMENT INTRODUCTION
 ISO 9000, ISO 9001, GMP, ICHQ10
 GMP FOR PHARMACEUTICAL PRODUCT
 RESOURCES: PERSONNEL, PREMISES,
MACHINE, DOCUMENTATION
 CRITICAL SUPPOTING FACILITIES: AHU,
WATER TREATMENT INSTALLATION
 PRESENTATION AND REVIEW
 MID SEMESTER EXAMINATION
 PROCESSES: SANITATION AND HYGIENE,
PRODUCTION
 QUALITY CONTROL
 SELF INSPECTION, COMPLAINT-RECALL-
RETURNED PRODUCT HANDLING
 CONTRACT MANUFACTURE & ANALYSIS
 QUALIFICATION & VALIDATION
 PRESENTATION & REVIEW
 FINAL SEMESTER EXAMINATION
 QUALITY MANAGEMENT
INTRODUCTION
 QUALITY MANAGEMENT AND HAPPINESS
 CONTEXT OF AN ORGANIZATION AND ISO 9000 RELATED
TERMS
 ORGANIZATION PURPOSE AND ISO 9000 RELATED TERMS
 PROCESS AND ISO 9000 RELATED TERMS
 REVIEW
 • QUALITY MANAGEMENT FOR HAPPINESS
WHAT?
Quality Management is management with regard to
quality.
Quality is ability to fulfil requirements.
Manajemen Mutu = Manajemen Kehidupan = Manajemen
Kebahagiaan.
Kehidupan dimulai dengan keingninan dan dijalani dengan
bahagia. Bahagia bukan tujuan , bahagia itu dalam
menjalani kehidupan. Tujuannya adalah makin bahagia.
Mutu Kunci Kebahagiaan > Kompetensi, Kebenaran,
Kepedulian (Cinta-Kasih)
Kompetensi > Kebijaksanaan, Kebenaran > Kedamaian,
Cinta-Kasih > Kebahagiaan
• Prinsip Hidup Bahagia = Prinsip Manajemen Mutu
“Hari ini harus lebih baik dari kemarin dan hari esok lebih
baik dari hari ini”.
MOTO
MUTU atau MATI
“ Selalulah bekerja benar sejak awal”.
Bersyukurlah, apapun hasilnya.
WHAT – WHY - HOW
Tetap bersemangat > lebih baik dan benar!
WHY?
Setiap tahapan kehidupan dimulai dengan
keinginan yang makin baik. Motivasi
BELAJAR EFEKTIF
mencapainya akan makin kuat. Makin
bahagia kitika sukses mencapainya.
Bahagia adalah senang dan puas tanpa
beban , karena keinginan yang benar diapai
Suka, Fokus, Repetisi
dengan cara yang benar.
HOW?
Belajar sepanyang hayat, aplikasikan
ilmunya. Terapkan prinsip Manajemen Mutu.
“Ingatlah: Setiap tempat > sekolah, setiap
orang > guru, setiap waktu > kesempatan”
Fig. 1 – Context of an Organization :
Internal Factors and External Factors •
CONTEXT OF AN ORGANIZATION
AND ISO 9000 RELATED TERMS
Require- Satisfac-
ments tion

QMS
Q
CUSTOMER & OTHER

CUSTOMER & OTHER

INTERESTED PARTIES

INTERESTED PARTIES
Orgization Structure
Processes, Procedures, Productivity =
Effectiveness/Efficiency
Resources
“Do it right from
The first time & every time”. QA LEGAL
Input > Process > Output
QM VALUES,
Reqmnts Effective Product
Resources Efficient Productivity
MARKET,
CULTURE
SOCIAL
CULTURE, ECONOMY,
KNOWLEDGE, TECHNOLOGY,
PERFORMANCE COMPETITION,
Feedback / Outcome / CAPA > Continual Improvement
Q = Quality, QM = Quality Management, QMS = Quality Management System, QA = Quality Assurance,
POAC = Planning, Organizing , Actuating, Controlling; PDCA + Plan, Do, Check, Act; CAPA= Corrective Action & Preventive Action.
 •
CONTEXT OF AN ORGANIZATION AND ISO 900O
RELATED TERMS •
• Organization
Person or group of people that has its own
functions with responsibilities, authorities and
relationships to achieve its objectives, e.g.
sole-trader, company, institution, association,
etc.
• Context of an organization, Business
or Organizational environment
Combination of internal and external issues
that can affect on an organization’s approach
to developing and achieving its objectives.
Internal issues: organization’s purpose (vision,
mission, policies, objectives), value, culture,
knowledge, performance.
External Issues: legal, market, competitive,
technological, cultural, social, and economic
environments
• Interested Party, Stakeholder
Person or organization that can affect, be
affected by, or perceive itself to be affected
by a decision or activity.
• Customer
Person or organization that could or does
receive a product or service that is intended
for or be required buy this person or organi-
zation.
Customer can be internal: receiver of the next
process, or external customer; consumer,
end-user, client, retailer.
• Provider, Supplier
Person or organization that provides a product
or a service. Provider can internal: the previous
process, or external provider: producer, distri-
butor, retailer, vendor, contractor,
• ORGANIZATION PURPOSE AND ISO 900O RELATED
TERMS

WHAT?
• Any Organization exists for a particular purpose.
• Organization purpose can be expressed by its vision, mission, policies and
objectives.
• Strategy or Strategic Plan shall be prepared to achieve a long-term or overall
objectives.
• Action Plan shall be prepared to achieve a short-term objective.
• Quality objective is result to be achieved with regard to quality.
• The purpose shall be clear about its Quality, Quantity, and Time.
• Achievable Purpose shall be SMART
( Specific, Measurable, Achievable, Reasonable, Timed)
TERMS•
ORGANIZATION PURPOSE AND ISO 900O RELATED

WHY?
• Action plan can not be planned accurately without clear objective.
• Clear objective facilitates the planning of a right plan.
• Right plan will facilitate the right action.
• Rigt action will produce quality product or sevice.
• Quality product or servive will fulfil requirements > satisfaction > happiness.

HOW?
• Seek to understand the purpose.
• Plan the purpose according to SMART principles.
• Do it right from the first time and every time.
 •ORGANIZATION PURPOSE AND ISO 900O RELATED
TERMS
• Vision Asiration of what an organization • Objective, aim, goal, target
would like to become as expressed by top Result to be achieved.
management. Top management is person or
group of people who directs and controls an
oeganization at the highest level. Top mgt
• Quality objective i Objective related to
has the power to delegate authority and quality. It is based on quality policy specified
provide resources. for relevant functions, levels and processes
• Mission Organization purpose for existing • Specification Document stating requirements.
as expressed by to management
e.g. Quality manual, quality plan, technical
• Policy Intention and direction of an organi- drawing, procedure document, work instructi-
zation as formally expressed by to on, process , test , product, performance,
management
• Quality Policy Policy with regard to • Quality Plan Specification of the procedures
quality., consistent with the overall policy, and associated resources to be applied when
can be aligned with vision-mission, and by whom to a specific object.
provides framework for stting of quality
policy.
• Quality Manual Specification for the QMS
• Strategy Plan to achieve a long-term or
• PROCESS AND ISO 9000 RELATED TERMS
Fig. 2 - The elements of
a single process

Starting Point End Point

Sources Receivers
Receiversofof
Sourcesofof Inputs Activities Outputs outputs
inputs Inputs Activities Outputs outputs
inputs
PREDESESSOR MATTER MATTER SUBSEQUENT
PROCESSES at: ENERGY ENERGY PROCESSES at
Customers, INFORMATION INFORMATION
Providers e.g. Materials, e.g. Product, External or
Other intersted Other resources Service, Internal
parties Requirements Decision Customers, and
. Other Relevant
Intersted parties.
Possible controls and check points
To monitor and measure performanc
 PROCESS AND ISO 9000 RELATED TERMS
• Process Set of interrelated and interacting
activities that use inputs to deliver intended result
(output, product, service).
A process may be two or more interrelated and
interacting process in series. Processes are geneally
planned and controlled to add value.
• Activity Smallest identified object of work in a
project. Project is unique process consisting of a
set of coordinated and controlled activities with
start and finish date.
• Requirement Need or expectation that is stated or
generally implied. Requirements can be generated
by differentinterested parties or by the
organization itself.
• Input Requirements needed to carry out a process
(materials, energy, information, other resources).
• Procedure Specified way to carry out an activity or
a process. It can be written or not
Monitoring Determining the status of a system, a
procss, a product, a service, or an activity,
whenever there is a need to check, supervice or
critically observed, at different stage or different
time.
Effectiveness Extent to which planned activities
are realized and planned results are achieved.
Efficiency Relationship between the result achied
an the resources used.
Quality Degree to which a set of inherent cha-
racteristics of an object fulfils requirements.
‘Inherent’ as opposed to ‘assigned’,
means existing in the object, e.g.price is assigned
characteristics. Quality may be poor, good or
excellent.
Risk Effect of uncertainty. Uncertainty is the state
, even partial, of deficiency of information
(meaningful data) related to, understanding or
knowledge of, an event, its consequence, or
likelihood.
 QMS ISO 9000
FUNDAMENTALS AND VOCABULARY
A. Scope
B. Fundamental Concepts and Quality Management Principles
1. Fundamental concepts
2. Quality Management Principles
3. Developing QMS
C. Terms and Definitions
 QMS ISO 9000
FUNDAMENTALS AND VOCABULARY

A. Scope: Any types, small or big organizations

> Organizations seeking for: sustained success, confiden in providing
product/service quality, confidence in their supply chain quality,
improving quality of communication;

> Organizations performing conformity assessment against ISO 9001;

> Developers of related standards.

 QMS ISO 9000
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B. Fundamental Concepts and Quality Management Principles

1. Fundamental concepts
- Quality Ability to fulfil requirements. Promote culture and processes that deliver value to satisfy
customer and other interested parties.

- Quality Management System: organization structure, processes, procedures,

resources.
- Context of An Organization: vision, mission, policies, objectives values, culture, knowledge,
performance; legal, technological, competitive, market, cultural, social and economic environments.
- Interested Parties: customers, suppliers, partners, governments, employee, owner.

- Support: top management, people & other resources, competence, awareness, communication.
 QMS ISO 9000
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B. Fundamental Concepts and Quality Management Principles
2. Quality Management Principles
a. Customer Focus
b. Leadership
c. Engagement of People
d. Process Approach
e. Improvement
f. Evidence-based Decision Making
g. Relationship Management
 QMS ISO 9000
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How?
2. Quality Management Principles - Recognize direct and indirect
a. Customer Focus customer, understand customer
requirements, benefitted
What? customers, link objectives to
Definition: Full attention to meet customer requirements customer requirements,
and to strive to exceed customer expectations. communicate customer
requirem ents throughout the
Benefit: increased customer value, satisfaction, loyalty, organization, plan-design-
reorder, reputation, customer base, market share, revenue. develop-produce-deliver-support
Why? products/ services to meet
custome requirements.
Sustained success is achieved by: attractings & retaining
Measure and monitor customer
customer confidence, creating value from customer satisfaction, take CAPA, manage
interaction ,understanding current & future needs of relationship with customer.
the interested parties.
 QMS ISO 9000
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2. Quality Management Principles

b. Leadership
What?
Definition: The way to lead in establishing unity of purpose and diection, and create
conditions in which all people are enggage in achieving organization’s quality objectives.
Benefit: Increased effectiveness and efficienccy, better coordination of processes,
improvement & development of capability.
Why?
Increased effectiveness & efficiency will be achieved in align strategies,, policies, processes
and resources by creation of unity of purpose, and direction,and engagement of people
 QMS ISO 9000
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2. Quality Management Principles
b. Leadership (continuation)
How?
- communicate vision, mission, strategy, policies and processes throughout
the organization;
- Establish a culture of trust and integrity;
- encourage an organization-wide commitment to quality;
- ensure leaders at all levels are positive examples (role models)
- provide people with the required, training, and authority to act with
accountability;
- inspire, encorage, and recognize the contribution of people.
 QMS ISO 9000
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2. Quality Management Principles
c. Engagement of People
What?
Definition: Involvement of competent, empowered people at all levels throughout the
organanization to enhance the organization’s capability to create and deliver value.
Benefit: Improved understanding and increased motivation to achieve the organization’s
quality objectives; enhanced: partisipation for improvement; personal developement,
initiatives, crativity, people satisfaction, trust and collaboration; inceased attention to shared
values and culture.

Why? Respect, recognition, empowerment, enhancement of competence, facilitate the

engagement of people in achieving the organization’s quality objectives efeectively and
efficiently.
 QMS ISO 9000
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2. Quality Management Principles
c. Engagement of People (Continuation)
How?
- Communicate the important of individual contribution;
- Promote collaboration;
- Empower people to determine constraints to performance and to take
initiative without fear;
- Enable self-evaluation of performance aginst personal objectives;
- Recognize and aknowledge people’s contributtion, learning and improvement;
- Facilitate open discussion & sharing of knowledge and experience
- Conduct surveys to assess people’s satisfaction, communicate tehe results, and
take appropriate actions.
 QMS ISO 9000
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2. Quality Management Principles
d. Process Approach
What?
Definition: Understanding and manage activities as interrelated processes that function as
coherent system to achieve consistent and predictable results more effectively and efficiently.
Benefit: Enhanced ability to focus effort on key processes and opportunities for improvement;
consistent and predictable outcomes; optimized performance and reduced cross-functional
barriers; enhance confidence of interested parties to organization’s consistency, effectiveness
and efficiency.
Why?
Understanding that the QMS consists of interrelated processes and how the results are produced,
enables an organization to optimize the system and its performance.
 QMS ISO 9000
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2. Quality Management Principles
d. Process Approach (continuation)
How?
- define objectives of the system, and processes necessary to achieve them;
- establish authority, responsibility and accountability for managing processes;
- understand the organization’s capabilities and determine resource constraints prior to action;
- determine process interdependencies and analyze the effects of modifications to individual
processes on the system as a whole;
- manage processes and their interrelations as a system to achieve the organization’s quality
objectives effectively and efficiently;
- ensure the necessary information is available to operate and improve the processes and to
monitor, analyse and evaluate the performance of the overall system;
- manage risks which can affect outputs of the processes and overall outcomes of the QMS.
 QMS ISO 9000
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2. Quality Management Principles
e. Improvement
What?
Definition Preventive or corrective actions taken after analysing and evaluating the discrepancies
of the current levels of performance of the processes or the whole system o the QMS, to maintain
the current levels of performance, to react to changes in its internal and external conditions and to
create new opportunities.
Benefit Improved: process performance, oganizational capability, customer satisfaction,
use of learning for improvement; Enhanced: focus on root cause investigation and determination,
followed by CAPA, ability to anticipate and react to internal and external risks and opportunities,
consideration of both incremental and breaktrough improvement, drive for innovation.
Why? Improvement is essential for an organ ization to maintain current levels of performance , to react to
changes in its internal and external conditions and to create opportunities.
 QMS ISO 9000
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2. Quality Management Principles
e. Improvement
How?
- Promote establishment of improvement objectives;
- Educate and train people to apply basic tools and methodologies to achieve
improvement objectives;
- Ensure people are competent to successfully promote and complete
improvement
project;
- Develop and deploy processes to implement improvement projects;
- Track, review and audit the planning, implementation, completion and results of
improvement project.
 QMS ISO 9000
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2. Quality Management Principles
f. Evidence-based Decision Making
What? Definition Factual approach to decision making, i.e. Conclusion be drawn after
analysing and evaluating facts or data in. accordance with the problem.
Benefit Improved decision making processes; Improved assessment of process performance
and ability to achieved objectives; improved operational effectiveness and efficiency; Increased
ability to review, challenge and change opinions & decisions; Increased ability to demonstrate the
effectiveness of past decisions.
Why?
Decision making can be a complex process, involves some uncertainty, multiple types and sources of
inputs & interpretations, which can be subjective. Cause & effect relationships and potensial
unintended consequencies must be understood, so that the decision made after facts, evidence and
data analysis lead to greater objectivity.
 QMS ISO 9000
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2. Quality Management Principles
f. Evidence-based Decision Making (contn)
How?
- Determine, measure and monitor key indicators to demonstrate organization’s
performance;
- Make all data needed available;
- Ensure that data and information are sufficiently accurate, reliable and secure;
- Analyse and evaluate data and information using suitable methods;
- Ensure people are competent to analyse and evaluate data as needed;
- Make decisions and take actions based on evidence, experience and intuition.
 QMS ISO 9000
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2. Quality Management Principles
g. Relationship Management
What?
Definition Management of relationships with relevant interested paties , such as providers, to
achieve sustain success of the organization.
Benefit Enhanced performance of the organizations through responding to the opportunities and
constraints; Common understanding of objectives and values; Increased capability to create value
for interested parties by sharing resources and competence and managing quality related resks;
A well manage supply chain that provides a stable flow of products and services.
Why?
The organization relationship with provviders and partners network will optimize the impact of its
performance.
 QMS ISO 9000
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2. Quality Management Principles

g. Relationship Management (contn)
How?
- Determine and prioritize relevant interested parties;
- Establish relationship that balance short-term gains and long-term considerations;
- Gather and share information, expertise and resources;
- Measure performance and provide feedback to enhance performance initiatives;
- Establish collaborative development and improvement;
- Encourage and recognize improvements and achievements.
 QMS ISO 9000
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2 Developing QMS Using Fundamental Concepts and Principles
a. QMS Model
What? QMS model is a unique set of interrelated and interacting elements of an organization
with regard to quality, to establish quality objectives, policies, and processes to achieve those
objectives. No QMS model can be predetermined, therefore it need to be flexible and adaptable
to the complexities of the organizational context for continual improvements.

Why? Organizations share many characteristics with humans as a living and learning social
organism to achieve their quality objectives and to improve the quality performance of the QMS.
Both are adaptive on their varying context, and comprise the interacting systems, processes and
activities. Organizations often innovate to achieve breakthrough improvements.
.
 QMS ISO 9000
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2. Developing QMS Using Fundamental Concepts and Principles (contn)
a. QMS Model
System System is set of interrelated and interacting elements. Organizations seek to understand the
internal and external context to identify the needs of relevant interested parties. This information is
use in the development of QMS to achieve organizational sustainability.
The system may be the overall network of the interlinked processes. The output of the previous
process can be the input of the next process. Although often appearing to be comprised of similar
processes, each organization and its QMS is unique.

Processes Process is set of interrelated and interacting activities that use inputs to deliver output
(an intended result). The process can be defined, measured and improved to deliver results consistent
with the organizational objectives and cross functional boundaries. As a system, processes have
interrelated activities with inputs to deliver outputs.
 QMS ISO 9000
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2 Developing QMS Using Fundamental Concepts and Principles
a. QMS Model (contn)
Activity
People carry out their daily activities to collaborate within a process. Some activities
are prescribed according to organization’s objectives, while others are not and react
to external stimuli to determine their nature and execution.
b. Development of a QMS
A QMS is a dynamic system that evolves over time through periods of improvement.
Every organization has quality manag ement activities. ISO 9000 provides guidance on
how to develop a formal system to manage these activities. The standard along with
ISO 9001 and ISO 9004 , can then be used to develop a cohesive QMS.
 QMS ISO 9000
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2> Developing QMS Using Fundamental Concepts and Principles
b. Development of a QMS (contn)
The QMS should reflect the need of the organization. A formal QMS provide a framework for
planning, executing, monitoring and improving the performance of quality management
activities. The QMS need to accurately reflect the need of the organization. In developing the
QMS, the fundamental concepts and the principles given in ISO 9000 can provide valuable
guidance.
The QMS should cover all guidance of ISO 9000 and ISO 9001. QMS planning is an ongoing
process . Plan evolve as the organization learns and circumstances change. It covers all guidance
of ISO 9000 and requirements of ISO 9001.
The implementation and the performance of the QMS should be regularly monitored
Auditing is a means of evaluating the effectiveness of the QMS. Effective audit collects tangible
and intangible evidence. Indicators should be carefully considered in order to identify risk and the
fulfilment of the requirements.. Correction ,improvement and the knowledge gained could lead to
innovation, taking QMS performance to higher levels.
 QMS ISO 9000
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2. Developing QMS Using Fundamental Concepts and Principles (contn)
c. QMS Standards, Other Management Systems and Excellence Models
All those management systems are based on common principles. They all enable the
organization to identify risks and opportunities, and contain guidance for improvement.
In current context, many issues such as innovation, ethics, trust and reputation could be
regarded as parameters within the QMS.

The QMS standards developed by ISO/TC 176 provide a comprehensive set of requirements
and guidelines for a QMS. ISO 9001 provides requirements for a QMS, ISO 9001 provides
guidance for sustainable success and improved performance of the QMS. Guidelines for
components, technical subject, and technical report in support of a QMS, have been published
by ISO.
 QMS ISO 9000
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3. Terms and Definitions
3.1. Terms related to person or people 3.12. Terms related to action
3.2. Terms related to organization 3.13. Terms related to audit
3.3. Terms related to activity
3.4. Terms related to process
3.5. Terms related to system
3.6. Terms related to requirement
3.7. Terms related to result
3.8. Terms related to data, information and document
3.9. Terms related to customer
3.10. Terms related to characteristic
3.11. Terms related to determination