Good practices in scientific research and regulatory compliance ensure integrity and reliability in non-clinical studies. These practices, better known as Good Laboratory Practices, a full form of GLP, make clinical health and safety decisions trustworthy and reproducible. They guarantee scientific rigor, the framework upon which the credibility of laboratory findings stands.  

GLP are part of Good Practice (GXP), a collection of quality guidelines and regulations designed to ensure that products are safe, meet their intended use, and adhere to quality processes during manufacturing, control, storage, and distribution. The "X" in GXP can stand for various aspects depending on the specific area of application, such as Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) or, as is the case, Good Laboratory Practices (GLP). 

This article aims to introduce good laboratory practices, their areas of application, real examples, and the key specifications and guidelines for GLP at the regulatory level.

 

What are Good Laboratory Practices?

 

Good Laboratory Practices are defined by the Organization for Economic Cooperation and Development (OECD) as a set of rules and criteria for quality systems concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, reported, and archived. GLP should be seen as a high-quality standard that ensures assay performance in a very organized and consistent manner for the results to be reliable. It must be followed to maintain dependably high standards and comply with internal company procedures, any regulations set by government agencies, and international regulations, like the 3Rs.

Test facilities such as laboratories conducting studies for submission to regulatory bodies adhere to the OECD Principles of Good Laboratory Practice. These studies aim to evaluate the health and environmental safety of chemicals and chemical products, including those of natural or biological origin. In some instances, these substances may also encompass living organisms. They also include the work conducted in greenhouses and for the agrochemical sector. 

GLP is applied in the pharmaceutical industry, but not exclusively, as GLP applies to the non-clinical safety testing of items contained in pesticide products, cosmetics, veterinary drugs, food additives, and industrial chemicals. Specific studies include toxicity and mutagenicity assays, water, soil, and air behavior, bioaccumulation, and studies to determine chemicals residues in food or animal feedstuffs.  


Studies not under the scope of good lab practices would include basic research (non-clinical pharmacology units for mechanisms of action and efficacy). Discovery toxicology studies, nonclinical pharmacokinetics evaluation not part of a GLP study, and bioanalysis of samples.

 

Good Laboratory Practices for 2024

 

Leaving the theoretical level to focus on its daily application, the quality control department ensures that GLP are met in companies. However, to ensure that this standard of quality is maintained, all team members in the organization must be involved by following a series of measures detailed below: 

 

  1. Standard Operating Procedures (SOPs)

SOPs are step-by-step instructions from any organization to help workers carry out routine tasks. These procedures ought to be well-documented and readily available to every team member. Beyond just guidelines, there should also be forms or documents for data registration. These records must be uniform, straightforward, thorough, signed by those who fulfilled them and dated.

 

  1. Data recording 

All the data belonging to the study should be captured and included in records that are safely stored. All data generated during the studies under GLP should be recorded directly, promptly, accurately, and legibly by the individual entering the information. These entries should be signed or initialed and dated. These data include the type of test, how it was performed (protocol and standard operating procedures), the dates, and who oversaw achieving it. Standard laboratory notebooks should be used, and data should be entered into computers in the correct format in checked paper format or with validated and compliant software for laboratory data entry. 

 

  1. Correct use of equipment

Equipment used in a study should be periodically inspected, cleaned, maintained, and calibrated according to standard operating procedures and under GLP certified providers. Records of these activities should be maintained and registered, too. Calibration should, where appropriate, be traceable to national or international measurement standards. 

 

  1. Tested items

Chemicals, reagents, and solutions should be labeled to indicate identity (with concentration if appropriate), expiry date, and specific storage instructions, including temperature, light/darkness, and humidity. Information concerning the source, preparation date, and stability should be available. The expiry date may be extended based on documented evaluations or analysis.

 

  1. Staff and training 

Only staff qualified to carry out testing procedures should do so. Staff should understand their role and have a job description. Records of staff qualifications and training and development should be kept. A preclinical research study is usually overseen by a Study director responsible for the study results. It is their role to check that the correct practice is followed and to sign off on the Protocol of the study and the Final report, including the results at the end of the study. 

 

  1. Facilities 

The test facility should be suitable in size, construction, and location to meet the study's requirements and minimize disturbance that would interfere with its validity. The design of the test facility should provide an adequate degree of separation of the different activities to ensure the proper development of each study and avoid cross-contamination.

 

  1. Audit and Inspections

Routine checks, internally and externally, are essential to ensure compliance with the abovementioned practices and identify any required adjustments. The internal inspections examine the research standard procedures (SOPs) Protocols and how results are reported. Internal audits prepared the staff and the lab for external audits. External audits are carried out by regulatory agencies such as the European Medicines Agency (EMA) and the Food and Drug Administration (FDA).

 

Who sets Good Laboratory Practices? Regulatory framework

 

In Europe, Good Laboratory Practices are set and overseen by the European Medicines Agency (EMA) in coordination with national competent authorities of the member states of the European Union (EU) for pharmaceutical products, and National Accreditation Agency (ENAC) for chemicals, agrochemicals, and food derivatives. These practices are harmonized across the EU through Directives 2004/9/EC to ensure consistency and compliance with the principles established by the OECD. 

 

In the United States, the Food and Drug Administration (FDA) establishes and enforces GLP standards for studies on developing and evaluating pharmaceuticals and medical devices on Part 58 of Title 21 of the Code of Federal Regulations. Additionally, the Environmental Protection Agency (EPA) sets GLP standards for environmental studies, such as those assessing the safety of pesticides and chemicals.

 

Both regions align their GLP standards with the OECD Principles of Good Laboratory Practice to facilitate the mutual acceptance of data among international regulatory bodies, streamlining the process for approving new products and ensuring their safety and efficacy.

 

In summary, GLP embodies scientific research quality, transparency, and accountability principles. It is indispensable for maintaining high standards in developing products that improve and protect our lives, demonstrating a commitment to scientific excellence and public safety.

 

 

Sources

Directive 2004/10/EC of the European Parliament and of the Council of 11th February 2004 on the Inspection and Verification of Good Laboratory Practice (GLP). EUR-Lex [Internet]. [cited 2024 Feb 19]. Available from: http://data.europa.eu/eli/dir/2004/10/2009-04-20

OECD Principles of Good Laboratory Practice (GLP) and GLP Compliance Monitoring. Organization for Economic Co-operation and Development (OECD) [Internet]. [cited 2024 Feb 19]. Available from: https://www.oecd.org/chemicalsafety/testing/overview-of-good-laboratory-practice.htm

Good Laboratory Practice Compliance. European Medicines Agency (EMA). [Internet]. [cited 2024 Feb 19]. Available from: https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-laboratory-practice-compliance