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The GLP Formula in France: What is it?

The  GLP Formula France  (for  Good Laboratory Practice )  is a set of quality principles governing the organization of non-clinical health safety studies. These principles guarantee the reliability, integrity and traceability of the data generated. In France, the implementation of the GLP is strictly regulated, particularly for trials conducted in the pharmaceutical, agrochemical, cosmetic and industrial chemical product sectors.

Origin and Objectives of the GLP

GLP was introduced in the 1970s by the OECD (Organisation for Economic Co-operation and Development) to address concerns about the validity of test data. The main objective is to ensure that studies are conducted to high standards,  thus enabling regulatory authorities to assess risks to human health and the environment .

Application of the GLP in France

In France,  the National Agency for Food, Environmental and Occupational Health Safety (ANSES)  and  the National Agency for the Safety of Medicines and Health Products (ANSM)  are responsible for the inspection and monitoring of laboratories subject to the GLP.

The establishments concerned must meet strict criteria, including:

• A documented quality system

• Qualified and trained staff

• Adapted facilities and equipment

• Strict data management (traceability, archiving, etc.)

• The implementation of an internal quality assurance program

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Scope of Application of GLP

The  GLP Formula France  is mandatory for all non-clinical safety studies carried out for regulatory dossiers in sectors such as:

• Medicines for human or veterinary use

• Plant protection products (pesticides)

• Food additives

• Cosmetic products

• Industrial chemicals (in accordance with REACH regulation)

Why is GLP important?

The adoption of GLP allows:

• Ensuring the validity of scientific results

• Ensure the protection of consumers and the environment

• Facilitate international acceptance of studies (particularly between OECD member countries)

Conclusion

GLP Formula France  represents a fundamental pillar of regulated research in France. It embodies the laboratories' commitment to producing reliable, high-quality data, essential for health and environmental decision-making. Any organization conducting non-clinical studies for regulatory purposes  must therefore comply with these requirements.

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