QUALITY MANAGEMENT

IN PHARMACEUTICAL INDUSTRY

Wayan Redja
2018

Fakultas Farmasi Universitas Pancasila

Jakarta
 QUALITY MANAGEMENT
IN PHARMACEUTICAL INDUSTRY

 QUALITY MANAGEMENT INTRODUCTION  PROCESSES: SANITATION AND HYGIENE,

 ISO 9000, ISO 9001, GMP, ICHQ10
 GMP FOR PHARMACEUTICAL PRODUCT
 RESOURCES
 AIR HANDLING UNIT
 WATER TREATMENT INSTALLATION
 PRESENTATION AND REVIEW
 MID SEMESTER EXAMINATION
PRODUCTION
 QUALITY CONTROL
 SELF INSPECTION, COMPLAINT-RECALL-
RETURNED PRODUCT HANDLING
 CONTRACT MANUFACTURE & ANALYSIS
 QUALIFICATION & VALIDATION
 PRESENTATION & REVIEW
 FINAL SEMESTER EXAMINATION
 QUALITY MANAGEMENT
POAC / PDCA
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
Input > Process > Output
QM Reqmnts
Resources
Effective Product
Efficient Productivity

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.
 QMS ISO 9000
FUNDAMENTALS AND VOCABULARY
• Scope
• Fundamental Concepts and Quality Management Principles
> Fundamental concepts
> Quality Management Principles
> Developing QMS
• Terms and Definitions
 QMS ISO 9000
FUNDAMENTALS AND VOCABULARY

• 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
FUNDAMENTALS AND VOCABULARY
• Fundamental Concepts and Quality Management Principles
> 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
FUNDAMENTALS AND VOCABULARY
• Fundamental Concepts and Quality Management Principles

> Quality Management Principles

1. Customer Focus
2. Leadership
3. Engagement of People
4. Process Approach
5. Improvement
6. Evidence-based Decision Making
7. Relationship Management
 QMS ISO 9000
FUNDAMENTALS AND VOCABULARY

> Quality Management Principles How?

1. Customer Focus - Understand customer
What? requirements, benefitted
customers, link objectives to
Definition: Full attention to meet customer requirements
customer requirements,
and to strive to exceed customer expectations. communicate customer
Benefit: increased customer value, satisfaction, loyalty, requirem ents throughout the
organization, plan-design-
reorder, reputation, customer base, market share, revenue.
develop-produce-deliver-support
Why? products/ services to meet
- Sustained success is achieved by: attractings & retaining custome requirements.
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.