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    VAL-035 In-House Trial Procedure Sample 2

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    Vizit31
    tdh

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    VAL-035 In-House Trial Procedure Sample 2

    Uploaded by

    Vizit31
    29 views1 page
    tdh

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    VAL-035 in-House Trial Procedure Sample 2

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    tdh

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    29 views1 page

    VAL-035 In-House Trial Procedure Sample 2

    Uploaded by

    Vizit31
    tdh

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 1

    Standard Operating Procedure

    Title: In-House Trial Procedure


    ______________________________________________________________________________________
    Copyrightwww.gmpsop.com. All rights reserved
    Unauthorized copying, publishing, transmission and distribution of any part of the content by electronic
    means are strictly prohibited. Page 4 of 6
    3.3.8. ALL trial documentation is kept. Documentation must be completed to GMP
    requirements and treated as per a routine batch unless the trial documents
    specifically instruct otherwise.
    3.3.9. ALL Laboratory samples, waste, product, reconciliations, in-process testing must be
    taken/performed as per a routine batch unless the trial documents specifically
    instruct otherwise.
    3.4. Trial Completion
    Once the actual trial has been executed, the documentation and results must be collated, the
    trial reported on, the batch disposition established, (where applicable) and the documents
    affected by the trial updated.
    3.4.1. The area Manager, (or delegate) must collect the trial documentation generated and
    perform a review, using the checklist provided with the protocol, to ensure all
    documentation is present and complete.
    3.4.2. The Trial Coordinator, (or delegate) is responsible for:
    3.4.2.1. Performing a review of the documentation and collecting any additional
    data required, (including Laboratory reports).
    3.4.2.2. Processing the results.
    3.4.2.3. Drawing up a trial conclusion with a clear outcome of the trial.
    3.4.2.4. Organising for the destruction of any non-saleable trial material.
    3.4.2.5. Communicating the trial outcome to all affected parties.
    3.4.3. Alterations to documents/processes as a result of the trial are to be carried out using
    the Change Control system.
    4. Trial Preparation Checklist
    The following lists some of the most common considerations that should be discussed at the Pre-
    Trial meeting:
    4.1. How much the cost involved?
    4.2. Does this trial have any impact on the product registration?
    4.3. Are all trial components available? If not, what is the lead-time required to order these?
    Will this interfere with supply of routine production components?
    4.4. Is this the most cost efficient way of achieving the trial outcome?
    4.5. Are MI (Manufacturing Instruction) sheets required / are MI sheet amendments required?
    4.6. What testing is required? Are test methods available for all required testing?
    4.7. Does each department have the resources (equipment and personnel) to support the trial?
    a) Production Review trial Protocol to ensure it can be fully understood by ALL
    production staff and it complies with the process. Review trial report and provide
    sufficient trained personnel to support the trial.
    b) Technical Service Provide sufficient resources to create manufacturing instruction
    update technical documents and stability cards as necessary.
    c) Validation/Engineering/QA Provide sufficient resources to write trial Protocols,
    execute and support trial protocols and write trial reports.
    d) Logistics schedule trials and order/allocate components.
    e) QA Review documents for GMP compliance.

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