Basic Principles of GMP
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Basic Principles of GMP. Quality Management. Section 1 and 2. Quality Management. Objectives To understand key issues in quality assurance/good manufacturing practices/quality control. To understand specific requirements on quality management and quality assurance including:

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Basic Principles of GMP

Quality Management

Section 1 and 2

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Quality Management


  • To understand key issues in quality assurance/good manufacturing practices/quality control.

  • To understand specific requirements on quality management and quality assurance including:

    • Organization

    • Procedures, processes and resources.

  • To develop actions to resolve your current problems.

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Quality Management

Quality relationships

Quality Management

Quality Assurance


Production and Quality Control

Section 1 and 2

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Quality Management

Philosophy and essential elements

  • What is Quality Management?

    • The aspect of management function that determines and implements the “quality policy”

    • The overall intention and direction regarding quality, as formally expressed and authorized by top management

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Quality Management

Quality Management

  • The basic elements are:

    • An appropriate infrastructure or “quality system” encompassing the organization structure, procedures, processes and resources

    • The systematic actions necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for “Quality”

      The totality of these actions is termed “Quality Assurance”

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Quality Management

Quality Management

  • Quality assurance is a management tool

  • In contractual situations, it also serves to generate confidence in a supplier

  • QA, GMP and Quality Control are interrelated aspects of Quality Management

    • They are described on the following slides in order to emphasize their relationship and their fundamental importance to the production and control of pharmaceutical products

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Quality Management

Principles of Quality Assurance (QA)

  • Wide-ranging concept

    • covers all matters that individually or collectively influence the quality of a product

  • Totality of the arrangements

    • to ensure that the drug is of the right quality for the intended use

  • Quality Assurance incorporates GMP

    • and also product design and development which is outside the scope of this module


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Quality Management

QA System should ensure:

  • Products are designed and developed correctly

    • Complying with, e.g. GMP, GCP, GLP

  • Production and control operations are defined

  • Managerial responsibilities are defined

    • In job descriptions

  • The manufacture, supply and use of correct starting and packaging materials

1.1 a- d

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Quality Management

QA System should ensure (2):

  • Controls are performed, including intermediates, bulk, calibration and validation

  • Correct processing and checking of the finished product

  • Products are sold/supplied only after review by the authorized person

    • Complying with marketing authorization, production and QC requirements

  • Proper storage, distribution and handling

1.1 e - h

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Quality Management

QA System should ensure (3):

  • Procedures for self-inspection and/or quality audits

  • Reporting, investigation and recording of deviations

  • System for change control/approval

  • Regular evaluation of product quality to verify consistency and continued improvement

1.1 i - l

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Quality Management

Quality Assurance

  • Manufacturer is responsible for the quality of the product

    • Fit for intended use

    • Comply with marketing authorization

    • Safety, efficacy and quality

  • Senior management and commitment of all staff


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Quality Management

Quality Assurance

  • Requires a comprehensively designed and well implemented QA system

  • Fully documented, and effectiveness monitored

  • Competent personnel, sufficient premises, equipment and facilities


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Quality Management

Good Manufacturing Practices (GMP)

  • That part of QA that ensures that products are consistently produced and controlled

    • Quality standards

    • Marketing authorization

  • Aim: Diminishing risks that cannot be controlled by testing of product

    • Contamination and cross-contamination

    • Mix-ups (confusion)


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Quality Management

Basic Requirements for GMP – I

  • Clearly defined and systematically reviewed processes

  • Qualification and validation is performed

  • Appropriate resources are provided:

    • Qualified and trained personnel

    • Premises, space, equipment and services

    • Materials, containers, labels

    • Procedures, storage, transport

    • Laboratories and in-process control

2.1 a - c

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Quality Management

Basic Requirements for GMP – I

  • Clear, written instructions and procedures

  • Trained operators

  • Records of actions, deviations and investigations

  • Records for manufacture and distribution

  • Proper storage and distribution

  • Systems for complaints and recalls

2.1 d - j

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Quality Management

Group session – I

  • How many GMP deficiencies can you find in the photographs in the handout?

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Quality Management

Group session II

  • Imagine you are inspecting a pharmaceutical company for compliance with GMP

  • Consider the situations in the next slides which may have impact on a company’s quality management programme

  • Describe the action to be taken in each case

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Quality Management

Issues – I

  • Quality Management manual not established in writing

  • Limited human resources

  • Lack of qualified people

  • Processes not properly validated

  • Poor SOPs or standard batch documentation

  • More consideration to cost than quality

  • Family members in key positions of authority

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Quality Management

Issues – II

  • Substandard materials deliberately purchased

  • Technical staff not involved in purchasing

  • Inability to re-export substandard materials

  • Owner insists on selling rejects

  • Corruption

  • No commitment to training