Image of picture line

TS1.6 Sampling

icon

This document is available in 3 different languages

Version: 1 January 2024

Download PDF

1. Scope of this document

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

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.

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:

  1. dry products (harrow in bulk, bagged), wet products, liquid products (harrow in tanks, cans), etc.;
  2. testing on substances which are heterogeneously / homogeneously distributed over the batch;
  3. 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

  1. 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;
  2. Sterile, if necessary;
  3. 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.

2.4. Number and size of sample(s)*

  1. The company must define the number and size of the (increment) sample(s) in order to achieve representative samples of the whole batch;
  2. 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;
  3. The bulk aggregate sample must then be divided and reduced until the required quantity needed for the final samples;
  4. 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

  1. 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;
  2. For each sample the following information must be available:
    • date of sampling,
    • product identification,
    • batch identification,
    • 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.).
  3. The sample must be sealed to ensure the integrity of the sample.

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

  1. The sample must be stored in such a way that damage to and deterioration is avoided;
  2. 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.

2.7. Sample taking

  1. 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).
  2. 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

  1. 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;
  2. 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;
  3. 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.

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/