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    Wayan Redja 2018 Fakultas Farmasi Universitas Pancasila Jakarta

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    didin k
    The document discusses quality management in the pharmaceutical industry. It covers topics such as quality management introduction, processes like sanitation and hygiene and production. It also discusses quality control, self-inspection, complaint handling, contract manufacturing, qualification and validation. The presentation provides an overview of quality management systems based on ISO 9000 standards and principles including customer focus, leadership, engagement of people, and process approach. It emphasizes the importance of quality management in fulfilling requirements and exceeding customer expectations.

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    Wayan Redja 2018 Fakultas Farmasi Universitas Pancasila Jakarta

    Uploaded by

    didin k
    37 views8 pages
    The document discusses quality management in the pharmaceutical industry. It covers topics such as quality management introduction, processes like sanitation and hygiene and production. It also discusses quality control, self-inspection, complaint handling, contract manufacturing, qualification and validation. The presentation provides an overview of quality management systems based on ISO 9000 standards and principles including customer focus, leadership, engagement of people, and process approach. It emphasizes the importance of quality management in fulfilling requirements and exceeding customer expectations.

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    QUALTY MANAGEMENT 2018

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    The document discusses quality management in the pharmaceutical industry. It covers topics such as quality management introduction, processes like sanitation and hygiene and production. It also discusses quality control, self-inspection, complaint handling, contract manufacturing, qualification and validation. The presentation provides an overview of quality management systems based on ISO 9000 standards and principles including customer focus, leadership, engagement of people, and process approach. It emphasizes the importance of quality management in fulfilling requirements and exceeding customer expectations.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    37 views8 pages

    Wayan Redja 2018 Fakultas Farmasi Universitas Pancasila Jakarta

    Uploaded by

    didin k
    The document discusses quality management in the pharmaceutical industry. It covers topics such as quality management introduction, processes like sanitation and hygiene and production. It also discusses quality control, self-inspection, complaint handling, contract manufacturing, qualification and validation. The presentation provides an overview of quality management systems based on ISO 9000 standards and principles including customer focus, leadership, engagement of people, and process approach. It emphasizes the importance of quality management in fulfilling requirements and exceeding customer expectations.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    of 8

    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,


    PRODUCTION
     ISO 9000, ISO 9001, GMP, ICHQ10  QUALITY CONTROL
     GMP FOR PHARMACEUTICAL PRODUCT
     SELF INSPECTION, COMPLAINT-RECALL-
     RESOURCES RETURNED PRODUCT HANDLING
     AIR HANDLING UNIT  CONTRACT MANUFACTURE & ANALYSIS
     WATER TREATMENT INSTALLATION  QUALIFICATION & VALIDATION
     PRESENTATION AND REVIEW  PRESENTATION & REVIEW
     FINAL SEMESTER EXAMINATION
     MID 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.

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