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GLP: Good Laboratory Practices

Glossary

GLP is the abbreviation of Good Laboratory Practices.

 

GLP guidelines are established by the FDA for non-clinical laboratory tests and studies conducted for assessing the safety and efficacy of the product. GLPs layout to define the framework for a non-clinical study and state how companies should be performed, evaluated, and reported. 21 CFR 58 Good laboratory practice for non-clinical laboratory studies

The guidelines of Good Laboratory Practices are the non-clinical counterpart of GCP. It comprises animal welfare as well during laboratory trials. As with any other form of GxP, GLP also requires extensive documentation of the details. It includes comprehensive documentation of lab samples and test animals.

If the tests are conducted on dead animals, they are rigidly regulated by GLP. It requires labs to handle specimens in perfectly humane ways under very definitive standards. Results are regularly reported and stored in order to enhance available data for future research.

If you need to read further about Good Laboratory Practices; check Chapter 6 of the “PICs Guide To Good Manufacturing Practice For Medicinal Products - Part I .“ Good quality control laboratory practices are explained in this chapter of the PICs guideline which is mainly focused on areas as follows:

  1. Documentation

    Laboratory documentation should follow the principles that are explained in this guideline. It’s important to have details that are required readily available in the documentation.

  2.  Sampling

    An SOP that describes the sampling steps should be in place. Such as sampling method, amount of sample, equipment to be used, identification of the containers, description of a representative sample, etc.
    Thus, sampling should be done under this approved SOP.

  3. Testing

    The test method should be validated in advance.
    Test results should be recorded using Good Documentation Practices.
    There should be SOPs that explain the stability, control, use of reagents, reference standards, culture media, as well as validated test methods.
    Furthermore, SOPs should define the decontamination methods for used microbiological media and strains. And If any animals are used for testing, there should be a detailed SOP for it as well.

  4. Ongoing stability program

    After marketing the product, the stability of the product should be monitored according to a continuous programme that will allow detecting any stability issue associated with the formulation in the marketed package.
    The ongoing stability program should be described in a written protocol. The stability protocol of an ongoing stability programme should be maintained until the end of the shelf-life period.

  5. Technical transfer of testing methods

    There should be a detailed written protocol that explains the technical transfer of testing methods from one laboratory (transferring laboratory) to another.

    Moreover, the term GLP is included in the ISO 10993-1. ISO 10993 is an important standard for the medical device industry that explains the Biological evaluation of medical
    devices —Part 1: Evaluation and testing within a risk management process. The description of GLP term in ISO 10993-1 as below:

     

    Good Laboratory Practice

    Any kind of testing to support a biological evaluation is anticipated to be a crucial part of the manufacturer’s quality management system and is subject to the same requirements for validation and traceability as any quality control test.

    Quality controls applicable to non-clinical testing are known as Good Laboratory Practice. GLP studies are performed to define quality standards in laboratories that are accredited in line with an internationally implemented governmental scheme. Commonly, it can be conducted under a laboratory quality system compliant with ISO/IEC 17025 or an equivalent standard.
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