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    Quality Assurance of Pharmaceuticals: Sharvini Farhana Chris Farhan

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    The document discusses quality assurance of pharmaceuticals, which is important given the substantial costs of drugs and high expectations for consistent quality. It describes how WHO works to set global standards and how quality assurance systems aim to ensure quality, provide evidence of quality, and build confidence. Quality assurance involves establishing processes for activities like purchasing, manufacturing, and quality control to monitor compliance with good manufacturing practices. It benefits patients by reducing defects and helps companies by improving production standards and compliance.

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    Quality Assurance of Pharmaceuticals: Sharvini Farhana Chris Farhan

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    nizam_ghani
    104 views25 pages
    The document discusses quality assurance of pharmaceuticals, which is important given the substantial costs of drugs and high expectations for consistent quality. It describes how WHO works to set global standards and how quality assurance systems aim to ensure quality, provide evidence of quality, and build confidence. Quality assurance involves establishing processes for activities like purchasing, manufacturing, and quality control to monitor compliance with good manufacturing practices. It benefits patients by reducing defects and helps companies by improving production standards and compliance.

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    Management

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    Quality Management

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    The document discusses quality assurance of pharmaceuticals, which is important given the substantial costs of drugs and high expectations for consistent quality. It describes how WHO works to set global standards and how quality assurance systems aim to ensure quality, provide evidence of quality, and build confidence. Quality assurance involves establishing processes for activities like purchasing, manufacturing, and quality control to monitor compliance with good manufacturing practices. It benefits patients by reducing defects and helps companies by improving production standards and compliance.

    Copyright:

    © All Rights Reserved
    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    104 views25 pages

    Quality Assurance of Pharmaceuticals: Sharvini Farhana Chris Farhan

    Uploaded by

    nizam_ghani
    The document discusses quality assurance of pharmaceuticals, which is important given the substantial costs of drugs and high expectations for consistent quality. It describes how WHO works to set global standards and how quality assurance systems aim to ensure quality, provide evidence of quality, and build confidence. Quality assurance involves establishing processes for activities like purchasing, manufacturing, and quality control to monitor compliance with good manufacturing practices. It benefits patients by reducing defects and helps companies by improving production standards and compliance.

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    Download as ppt, pdf, or txt
    of 25

    QUALITY

    ASSURANCE OF
    PHARMACEUTICALS
    Sharvini Farhana Chris Farhan
    The quality of pharmaceuticals has been a
    concern of the World Health Organization
    (WHO) since its inception.
    The setting of global standards is requested in
    Article 2 of the WHO Constitution, which cites as
    one of the Organizations functions that it should
    develop, establish and promote international
    standards with respect to food, biological,
    pharmaceutical and similar products.
    Introduction
    Every government allocates a substantial
    proportion of its total health budget to drugs.
    There need to be an assurance these drugs
    meet acceptable standards of quality, safety and
    efficacy.
    Proper administrative and technical efforts is
    directed to ensure that patients receive effective
    drugs of good quality.

    Medicines have a very high research,
    development and production costs
    Special natures in these products is in need for
    high level of product consistency resulting a
    demand for highly regulated production
    processes
    High expectation from consumers such as
    patients also plays a major role
    All these factors have resulted in the need for
    advanced quality assurance system in the batch
    production for medicines
    Quality assurance system is constructed
    by merging a series of actions. These
    action collectively ensure product quality.
    As a result, quality assurance system must
    Establish specific activities before production
    begins
    Control factors during production
    Evaluate results following production

    Differences exist in the organization of a quality
    assurance system in each manufacturing facility.
    However, there are certain fundamental features
    of any quality system, this Include:
    Quality policy which defines the purpose and
    objectives of the pharmaceutical manufacturing
    facility: It also outlines the ways in which these
    objectives will be achieved
    Resources which include materials, equipment and
    personnel
    Documentation which includes procedures
    and standards
    An audit process to provide assurance that
    procedures have been compiled with; this
    process can also be used to improve the
    quality system

    Activities
    Activities involving pharmaceutical production
    process:
    Purchasing
    Dispatching
    Warehousing
    Operational protocols
    Manufacturing
    Training
    Quality control
    Validation
    packaging
    The system for each of the listed activities
    must provide:
    Assurance that materials, product, labelling,
    and storage have conformed to an
    established programme of operation
    Monitoring to ensure that the system is
    complied with or updated
    Production process must also be carried out
    according to good manufacturing practice. All
    processes must be monitored both during and
    after the activity.
    Details of the manufacturing procedures must be
    entered onto documents known as records
    Records form a history of the production process
    and are available for further study

    As a result of these actions, quality
    assurance system will:
    Ensure quality
    Provide evidence
    General confidence


    Implementing quality assurance in a
    manufacturing facility is expensive.
    However, cost are greatly outweighed by
    benefits of a quality assurance system.
    Higher standards in production
    Compliance with regulatory requirements
    Reduce waste
    Less risk of product defects

    Quality assurance in pharmaceutical
    manufacturing encompasses both good
    manufacturing practice and quality control
    systems. It involves with product design
    and process development.
    Ultimately, all these areas contribute in
    assuring the quality of the product
    The concepts are interrelated and
    encapsulated by the term quality
    assurance.
    Improving performance
    Errors arising in the pharmacy can directly affect
    the patients and the provision of poor advice to
    prescriber or patients can cause similar harm
    Pharmacist should carry out an assessment of
    each prescription. In this process, the
    pharmacist applies knowledge to establish
    safety, quality, efficacy, and cost effective use of
    the medicinal treatment specified by the
    prescriber
    A second competent person should carry out
    dispensing accuracy checks.
    In order to minimize or eliminate potential
    problems of error, the dispensary work area
    should provide:
    Segregation from the intense activities of the
    pharmacy with minimization of dispenser distractions
    An area designed for smooth workflow
    Suitable illumination, with an uncluttered work area
    Comfortable temperature and humidify for the work
    personnel
    Suitable storage of medicines
    To provide easy access ,this information
    are reproduced in the two volumes of
    publication:

    Volume 1
    Quality assurance of pharmaceuticals: a compendium of
    guidelines and related materials
    Published by WHO in 1997
    Material relating to national drug regulations,
    product assessment and registration,
    The international pharmacopoeia and related activities,
    international trade in pharmaceuticals and distribution,
    counterfeit products,
    basic tests for pharmaceutical products and
    training of technical personnel
    Volume 2
    Published in 1999,
    reproduces guidelines
    related to GMP and to inspection of
    pharmaceutical
    manufacturers and drug distribution
    channels.

    Good manufacturing practice
    (GMP)
    198990, GMP guidelines revised and
    expanded.
    Approved by the WHO Expert Committee
    on Specifications for Pharmaceutical
    19922003, published


    GMP
    GMP ensures that manufacturing
    processes are defined validated and
    reviewed according to laid-down
    procedures. It includes:
    Training for personnel and the use of suitable
    equipment and suitable premises
    Correct materials with suitable transport and
    storage are necessary both manufacture and
    national level
    GMP guidelines are advisory in nature.
    In 1996, GMP guidelines published for
    validation of manufacturing process.
    Explains and promote the concept of
    validation.
    Assist to develop a validation programme.
    In 1997,approved explanatory text on role
    and functions of the authorized person
    (the person responsible for the release of
    batches of finished products for sale)
    GMP
    Other specialized GMP guidelines
    published by WHO:
    a) for biological products,
    b) investigational pharmaceutical products,
    c) herbal medicinal products,
    d) radiopharmaceuticals,etc

    Inspection
    Pre-approval and periodic inspection
    Inspection of pharmaceutical manufacturers
    Inspection of drug distribution channels
    Quality systems requirements for national good
    manufacturing practice inspectorates exp:
    -Quality Management Systems (ISO 9001)
    -Environmental Management System
    (ISO 14000)
    -Laboratory Quality Management System (ISO/IEC)
    Guidance on good manufacturing practices: inspection
    report
    Model certificate of good manufacturing practices
    Hazards and risk analysis in
    Pharmaceutical products
    covered and controlled through the
    validation of critical operations and
    processes
    Hazard analysis and critical control point
    (HACCP) is applied to food safety
    management system.
    Finally
    Implementation of quality assurance
    mechanisms in the Pharmaceutical field
    will significantly contribute to decreasing
    errors and ultimately provide an improved
    health care service for the patients

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