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    Who Hold Time Studies Rev1 Comment

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    The document provides comments on the WHO Working Document QAS/13.521/Rev.1 "General Guidance for Inspectors on ‘Hold-Time’ Studies". The International Society for Pharmaceutical Engineering (ISPE) welcomes the guidance document and its intent to provide a harmonized approach to hold-time studies. ISPE submitted several comments for clarification and improvement of the guidance document, including recommending that hold times be determined prior to marketing using a risk-based approach, and that examples for oral liquids be included given their risk of microbial growth.

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    Who Hold Time Studies Rev1 Comment

    Uploaded by

    schumon
    113 views4 pages
    The document provides comments on the WHO Working Document QAS/13.521/Rev.1 "General Guidance for Inspectors on ‘Hold-Time’ Studies". The International Society for Pharmaceutical Engineering (ISPE) welcomes the guidance document and its intent to provide a harmonized approach to hold-time studies. ISPE submitted several comments for clarification and improvement of the guidance document, including recommending that hold times be determined prior to marketing using a risk-based approach, and that examples for oral liquids be included given their risk of microbial growth.

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    Who Hold Time Studies

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    The document provides comments on the WHO Working Document QAS/13.521/Rev.1 "General Guidance for Inspectors on ‘Hold-Time’ Studies". The International Society for Pharmaceutical Engineering (ISPE) welcomes the guidance document and its intent to provide a harmonized approach to hold-time studies. ISPE submitted several comments for clarification and improvement of the guidance document, including recommending that hold times be determined prior to marketing using a risk-based approach, and that examples for oral liquids be included given their risk of microbial growth.

    Copyright:

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

    Who Hold Time Studies Rev1 Comment

    Uploaded by

    schumon
    The document provides comments on the WHO Working Document QAS/13.521/Rev.1 "General Guidance for Inspectors on ‘Hold-Time’ Studies". The International Society for Pharmaceutical Engineering (ISPE) welcomes the guidance document and its intent to provide a harmonized approach to hold-time studies. ISPE submitted several comments for clarification and improvement of the guidance document, including recommending that hold times be determined prior to marketing using a risk-based approach, and that examples for oral liquids be included given their risk of microbial growth.

    Copyright:

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

    11 September, 2013

    Dr Sabine Kopp
    Manager, Medicines Quality Assurance Programme
    Quality Assurance and Safety: Medicines
    World Health Organization
    1211 Geneva 27
    Switzerland

    Subject: Submission of comments for WHO Working Document QAS/13.521/Rev.1,


    General Guidance for Inspectors on Hold-Time Studies

    Dear Dr. Kopp,

    ISPE welcomes the opportunity to comment on the WHO General Guidance for Inspectors on
    Hold-Time Studies. ISPE welcomes this guidance document; the intent to provide
    manufacturers/ inspectors with a harmonized approach to Hold- Time studies is fully
    supported. Our comments are attached.

    The International Society for Pharmaceutical Engineering (ISPE) is an individual membership


    Society of more than 20,000 professionals involved in the manufacture of pharmaceuticals and
    related products. All scientific and technical areas of the pharmaceutical manufacturing industry
    are represented among the ISPE Membership. ISPE is committed to creating a forum for uniting
    the worlds pharmaceutical manufacturing community and regulators.

    Thank you again for the opportunity to provide feedback on this draft guidance. Please feel free
    to contact me if you have any questions.

    Yours sincerely,

    President/CEO, ISPE

    cc: Ms. Marie Gaspard


    Comments on WHO Working Document QAS/13.521/Rev.1
    Title of the document:
    General Guidance for Inspectors on Hold-Time Studies
    Comments submitted by : ISPE International Society for Pharmaceutical Engineering
    Telephone number : +1 813-960-2105
    Email : [email protected]
    Template for comments
    Kindly complete the table without modifying the format of the document - thank you.

    General comment(s) if any Originator of


    the comments

    ISPE welcomes this guidance document.


    The intent to provide manufacturers/ inspectors with a harmonized approach to Hold- Time studies is fully supported.

    # Line no. Comment / Rationale Proposed change / suggested text Classificatio Originator
    section n of the
    comments
    L= low
    M= medium
    H= high
    Introduc 71 Storage should be extended by the term staging. Storage and staging should not have any negative L
    tion
    Introduc 76 It is essential for temperature sensitive material that the These time periods must be supported by adequate M
    tion hold time incorporates temperature limits. The hold time data to demonstrate that the product subject to the
    must be connected to the temperature. allowed hold time conditions will be stable throughout
    the approved shelf-life.

    20/09/2013 - 15:38:50 - table for comments 1/3


    # Line no. Comment / Rationale Proposed change / suggested text Classificatio Originator
    section n of the
    comments
    L= low
    M= medium
    H= high
    Scope 107 It will be difficult for third world countries to develop a Hold times should normally be determined prior to H
    hold time study prior to marketing. The approach on marketing of the product and following any significant
    determining hold times must be risk based e.g.use as a change in processes, equipment, starting and
    default the longest duration during the first validation packaging material, using a scientific risk based
    batch. approach.
    Scope 107 Re hold times should normally be determined prior to Insert Especially for sensitive products tentative hold L
    marketing of a product For sensitive material a hold times for each stage of the process may be provided by
    time may be provided by the transferring site or R&D the transferring or R&D site and these can be utilised
    lab. to confirm and document hold time specific to the
    production site.
    Scope 110 Determination of hold-time studies of existing product For products already marketed retrospective risk based M
    should be on a similar risk based approach basis. hold time studies should be performed.
    Scope 127 The statement, Generally, as an example for oral tablets, Insert Note: A hold time for equipment before it M
    the following stages should be considered - does not should be cleaned should be established especially for
    include hold time for the equipment before it could be microbiological aspects.
    taken up for cleaning. Guidance in this section is
    considered appropriate.
    Scope 127 Oral liquid hold time studies are equally important. Insert an example for Oral Liquids. M
    Hence an example for oral liquid manufacturing should The following stages should be considered:
    also be included particularly as oral liquids might have a - Sugar Syrup manufacturing to addition in bulk
    greater risk of microbial growth if the hold time is - Bulk solution (after filtration: ready for
    exceeded. packing to filling and sealing
    - Maximum filling period (covering worst case
    conditions)

    20/09/2013 - 15:38:50 - table for comments 2/3


    # Line no. Comment / Rationale Proposed change / suggested text Classificatio Originator
    section n of the
    comments
    L= low
    M= medium
    H= high
    Scope 147 If head space becomes an issue, the head space Insert Where head space is important the hold-time M
    proportion should consider worst case scenario with high samples should represent the maximum possible head
    head space space (worse-case scenario) to bulk stored in
    manufacturing/quarantine
    Scope 171 The risk assessment should also cover the hold time Risk assessment (product specific) may further assist M
    conditions, particularly temperature. manufacturers to determine which stage, tests,
    intervals and storage periods and storage conditions
    should be considered for a hold time study
    Table 2 178 Dispensed material storage: It is not always possible to Microbial test: Other specific tests depending on the M
    meet the same conditions/pack used by the manufacturer. material and packaging used may need to be
    In addition to microbial tests other factors as appropriate considered.
    for the materials should be considered. For example,
    some materials would degrade / absorb moisture/
    decolorise if required conditions are not met with.

    Please add rows as necessary (with "copy and paste"


    empty rows)

    20/09/2013 - 15:38:50 - table for comments 3/3

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