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    TS1.6 Amostragem

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    gianne.marin
    The document establishes minimum sampling requirements for sampling in the framework of GMP+ Feed Safety Assurance. It details where and how to take samples, required equipment, sample size, labeling, storage, and other considerations to ensure representative samples. Compliance with existing sampling standards can fulfill these requirements.

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    TS1.6 Amostragem

    Uploaded by

    gianne.marin
    13 views8 pages
    The document establishes minimum sampling requirements for sampling in the framework of GMP+ Feed Safety Assurance. It details where and how to take samples, required equipment, sample size, labeling, storage, and other considerations to ensure representative samples. Compliance with existing sampling standards can fulfill these requirements.

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    © © All Rights Reserved

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    The document establishes minimum sampling requirements for sampling in the framework of GMP+ Feed Safety Assurance. It details where and how to take samples, required equipment, sample size, labeling, storage, and other considerations to ensure representative samples. Compliance with existing sampling standards can fulfill these requirements.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    13 views8 pages

    TS1.6 Amostragem

    Uploaded by

    gianne.marin
    The document establishes minimum sampling requirements for sampling in the framework of GMP+ Feed Safety Assurance. It details where and how to take samples, required equipment, sample size, labeling, storage, and other considerations to ensure representative samples. Compliance with existing sampling standards can fulfill these requirements.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 8

    Technical Specifications

    TS1.6 - Sampling

    Version EN: 1 January 2024

    gmpplus.org
    TS1.6 - Sampling

    Index
    1. SCOPE OF THIS DOCUMENT 3

    2. SAMPLING REQUIREMENTS 4

    2.1. HOW TO SAMPLE 4


    2.2. WHERE TO SAMPLE 4
    2.3. USED EQUIPMENT 4
    2.4. NUMBER AND SIZE OF SAMPLE(S)* 5
    2.5. LABELLING, SEALING AND REGISTRATION 5
    2.6. STORAGE 5
    2.7. SAMPLE TAKING 6
    2.8. OTHER REQUIREMENTS 6

    Version EN: 1 January 2024 2/8


    TS1.6 - Sampling

    1. Scope of this document


    This document establishes minimum sampling requirements for sampling in the framework of
    GMP+ Feed Safety Assurance.

    Version EN: 1 January 2024 3/8


    TS1.6 - Sampling

    2. Sampling requirements
    In line with the GMP+ principles, it is the company's responsibility to determine to take
    representative samples as part of the feed safety management system, including compliance
    with relevant legislation.

    The GMP+ certified company must establish sampling protocols. Samples must be
    representative to the related batch.

    Helpful tip:
    If sampling is done in compliance with existing sampling standards, you can just refer to these standards.
    Examples of such standards are: GAFTA 124 (for dry feed materials), FOSFA, NOFOTA, ISO5555 (for fats
    and oils), ISO6497, ISO24333, Regulation (EU) 691/2013. Further, these standards contain information
    that can be useful when establishing your own protocols.

    Sampling protocols must address the following topics:

    2.1. How to sample


    Sampling method for different types of products, including specific requirements for:

    a. dry products (harrow in bulk, bagged), wet products, liquid products (harrow in tanks,
    cans), etc.;
    b. testing on substances which are heterogeneously / homogeneously distributed over the
    batch;
    c. testing on microbiological parameters.

    2.2. Where to sample


    The GMP+ certified company must define where in the process representative samples can be
    taken.

    2.3. Used equipment


    a. All the (automatic) sampling equipment including eg sample bags or cans must be clean,
    dry and free of remnants and odors foreign to the product;
    b. Sterile, if necessary;
    c. Sampling equipment and tools must not have any influence on the representativeness of
    the final sample(s) nor on any of the parameters likely to be analyzed.

    Version EN: 1 January 2024 4/8


    TS1.6 - Sampling

    2.4. Number and size of sample(s) 1


    a. The company must define the number and size of the (increment) sample(s) in order to
    achieve representative samples of the whole batch;
    b. The (increment) sample(s) representing the total batch must be thoroughly mixed into a
    bulk aggregate sample in an area free from any possible contamination;
    c. The bulk aggregate sample must then be divided and reduced until the required quantity
    needed for the final samples;
    d. The size of the final sample(s) is(are) sufficient to serve as retain sample and to carry out all
    necessary analyses, including any re-analyses.

    2.5. Labelling, sealing and registration


    a. The sample must be labelled and stored in such a way that it can be found in a timely
    manner and traced back to the corresponding batch;
    b. For each sample the following information must be available:
    ◦ b.date of sampling,
    ◦ b.product identification,
    ◦ b.batch identification,
    ◦ b.sampling point.
    Note: The above information does not necessarily have to be on the label but must be
    easily available (eg via bar code, QR code, etc.).
    c. The sample must be sealed to ensure the integrity of the sample.

    Helpful tip:
    The word 'sealed' in this context does not mean that sealing must take place with a seal lead and seal
    thread. The closure must be such that unauthorized and uncontrolled opening of the sample (for
    example by someone who is not authorized to do so) becomes visible.

    2.6. Storage
    a. The sample must be stored in such a way that damage to and deterioration is avoided;
    b. An appropriate period must be established to store retention samples. Where legislation
    requires a specific storage period of the retention samples, this must be met.

    1. [1] Note: For a definition of increment sample, (bulk) aggregate sample and final sample see F0.2 Definition list.

    Version EN: 1 January 2024 5/8


    TS1.6 - Sampling

    2.7. Sample taking


    a. Sampling must be performed in accordance with the established sampling protocols. The
    sample taker must be:
    1. trained to understand and properly execute the established sampling protocols. This
    includes knowledge of the products to be sampled and how to work with the sampling
    equipment;
    2. able to sample the products in accordance with the established sampling protocols. This
    includes access to all places where samples are to be taken and free of influence that
    may affect the representativeness of the sample(s).
    b. Samples taken according to well-known and recognized sampling standards can be used
    as part of the feed safety assurance (GMP+ FSMS).

    2.8. Other requirements


    a. The GMP+ certified company assures that relevant requirements and criteria, which are laid
    down in this document and not covered in the specific sampling standards, are met;
    b. Where in legislation or in other parts of the GMP+ FC scheme (eg TS1.7 Monitoring)
    specific sampling is required, these requirements must be met. In case of conflict, they
    prevail above the requirements in this document;
    c. The GMP+ certified company may outsource the sampling and storage of the samples.
    Documented information must demonstrate that the requirements laid down in this
    document are covered and that these requirements are monitored for compliance.

    Version EN: 1 January 2024 6/8


    TS1.6 - Sampling

    Feed Support Products


    Feed Support Products

    That was a lot of information to digest and one might ask, what is the next step? Luckily we can offer support
    for the GMP+ Community when doing this. We provide support by means of various tools and guidances but
    as each company has a shared responsibility to feed safety, and therefor tailor-made solutions cannot be
    offered. However, we do help by explaining requirements and provide background information about the
    requirements.

    We have developed various supporting materials for the GMP+ Community. These include various tools,
    ranging from Frequently Asked Questions (FAQ) lists to webinars and events.

    Where to find more about the GMP+ International Feed Support Products
    Fact sheets
    More information: https://fsd.gmpplus.org/pagina/6/fact-sheets.aspx/
    GMP+ Portal
    More information: https://portal.gmpplus.org/en-US/

    Version EN: 1 January 2024 7/8


    TS1.6 - Sampling

    We enable every company in the


    feed chain to take responsibility for
    safe and sustainable feed.

    GMP+ International
    Braillelaan 9
    2289 CL Rijswijk
    The Netherlands
    t. +31 (0)70 – 307 41 20 (Office)
    +31 (0)70 – 307 41 44 (Help Desk)
    e. [email protected]

    Disclaimer:
    This publication was established for the purpose of providing information to interested parties
    with respect to GMP+-standards. The publication will be updated regularly. GMP+
    International B.V. is not liable for any inaccuracies in this publication.

    © GMP+ International B.V.


    All rights reserved. The information in this publication may be consulted on the screen,
    downloaded and printed as long as this is done for your own, non-commercial use. For other
    desired uses, prior written permission should be obtained from the GMP+ International B.V.

    gmpplus.org

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