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    Production in Pharmaceutical Industries

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    RainMan75
    The document outlines principles for production in the pharmaceutical industry to ensure quality. It states that production must follow Good Manufacturing Processes and be performed by competent individuals according to written procedures. All materials and products must be properly stored, monitored, and protected from contamination throughout the production process. Deviations from procedures must be approved and documented.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd

    Production in Pharmaceutical Industries

    Uploaded by

    RainMan75
    191 views4 pages
    The document outlines principles for production in the pharmaceutical industry to ensure quality. It states that production must follow Good Manufacturing Processes and be performed by competent individuals according to written procedures. All materials and products must be properly stored, monitored, and protected from contamination throughout the production process. Deviations from procedures must be approved and documented.

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    Production in Pharmaceutical Industries

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    The document outlines principles for production in the pharmaceutical industry to ensure quality. It states that production must follow Good Manufacturing Processes and be performed by competent individuals according to written procedures. All materials and products must be properly stored, monitored, and protected from contamination throughout the production process. Deviations from procedures must be approved and documented.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    191 views4 pages

    Production in Pharmaceutical Industries

    Uploaded by

    RainMan75
    The document outlines principles for production in the pharmaceutical industry to ensure quality. It states that production must follow Good Manufacturing Processes and be performed by competent individuals according to written procedures. All materials and products must be properly stored, monitored, and protected from contamination throughout the production process. Deviations from procedures must be approved and documented.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 4

    Production in Pharmaceutical Industries

    Production department must follow all Principles of Good Manufacturing


    process in order to get Quality defined by respective Manufacturing &
    Marketing Authorities.

     Production should be performed and supervised by


    competent people.All handling of materials and products,
    such as receipt and quarantine, sampling, storage,
    labelling, dispensing, processing, packaging and
    distribution should be done in accordance with written
    procedures or instructions and, where necessary,
    recorded.

     All incoming materials should be checked to ensure that


    the consignment corresponds to the order. Containers
    should be cleaned where necessary and labelled with the
    prescribed data.

     Damage to containers and any other problem which


    might adversely affect the quality of a material should be
    investigated, recorded and reported to the Quality
    Control Department.

     Incoming materials and finished products should be


    physically or administratively quarantined immediately
    after receipt or processing, until they have been released
    for use or distribution.

     Intermediate and bulk products purchased as such should


    be handled on receipt as though they were starting
    materials.

     All materials and products should be stored under the


    appropriate conditions established by the manufacturer
    and in an orderly fashion to permit batch segregation and
    stock rotation.

     Checks on yields, and reconciliation of quantities, should


    be carried out as necessary to ensure that there are no
    discrepancies outside acceptable limits.Operations on
    different products should not be carried out
    simultaneously or consecutively in the same room unless
    there is no risk of mix-up or crosscontamination.

     At every stage of processing, products and materials


    should be protected from microbial and other
    contamination.

     When working with dry materials and products, special


    precautions should be taken to prevent the generation and
    dissemination of dust. This applies particularly to the
    handling of highly active or sensitising materials.
     At all times during processing, all materials, bulk
    containers, major items of equipment and where
    appropriate rooms used should be labelled or otherwise
    identified with an indication of the product or material
    being processed, its strength (where applicable) and
    batch number. Where applicable, this indication should
    also mention the stage of production.

     Labels applied to containers, equipment or premises


    should be clear, unambiguous and in the company’s
    agreed format. It is often helpful in addition to the
    wording on the labels to use colours to indicate status
    (for example, quarantined, accepted, rejected, clean).

     Checks should be carried out to ensure that pipelines and


    other pieces of equipment used for the transportation of
    products from one area to another are connected in a
    correct manner.

     Any deviation from instructions or procedures should be


    avoided as far as possible. If a deviation occurs, it should
    be approved in writing by a competent person, with the
    involvement of the Quality Control department when
    appropriate.

     Access to production premises should be restricted to


    authorised personnel.
    Sr. No. Topics of Production

    Prevention of Cross-Contamination in Production

    1. – Technical Measures

    – Organisational Measures

    2. Validation

    Starting materials
    – Active substances
    3.
    – Excipients

    4. Processing operations: intermediate and bulk products

    5. Packaging materials

    6. Packaging operations

    7. Finished products

    8. Rejected, recovered and returned materials

    9. Product shortage due to manufacturing constraints

    10 Equipment

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