GLP: Good Laboratory Practice

GLP principles were created by the Organization for Economic Cooperation and Development (OECD) for non-clinical trials conducted by manufacturers of certain products or medications ^[1].

Non-clinical trials focus on testing drugs or treatments in laboratory or animal settings, while clinical trials usually involve testing on human participants.

The purpose of GLP principles is to ensure the quality, reliability, traceability, and integrity of data in non-clinical studies. The principles encompass the following areas:

• Quality Management Systems for laboratory operations
• Standard Operating Procedures (SOPs) for laboratory activities and processes
• Training and qualification for employees
• Facilities and equipment maintenance, calibration, and validation
• Documentation and record-keeping for experimental procedures, observations, raw data, calculations, and results
• Data integrity and management of all study data (including data collection, storage, analysis, and reporting)
• Quality Assurance (QA) measures, including internal audits, inspections, and reviews

GLP apply to manufacturers that conduct non-clinical trials of products or medications in the following areas:

• Chemicals
• Pharmaceuticals
• Veterinary medicines
• Pesticides
• Biocides

Compliance with GLP is usually mandatory. However, these guidelines can vary from country to country, including the USA, UK, and EU, where there are may be specific regulations or interpretations of GLP principles.

GLP is not a certification, rather a set of principles with which organizations must comply ^[2]. To demonstrate compliance, organizations can undergo inspections or audits from regulatory agencies or accreditation bodies.

Individual employees can also participate in training programs that help them understand and implement GLP principles in the workplace.

Because GLP principles are not a certification, there are no renewal requirements. However, some organizations may be required to undergo audits to ensure that they maintain compliance.

The frequency of these audits depends on the type of organization and its geographical location. Organizations conducting nonclinical trials that fall under the GLP’s umbrella should check with their relevant regulatory agency, such as the FDA ^[3] or European Medicines Agency.

Implementing GLP principles offers several benefits to organizations. Some key advantages include the following.

Implementing GLP principles may pose several challenges to organizations. They include the following.

Here are a few tips for preparing for a GLP compliance audit:

• Familiarize yourself with the OECD’s official GLP principles
• Review the European Commission’s “GLP Questions & Answers” document
• Read the FDA’s “Good Laboratory Practice (GLP) 101” document

For more information and guidance on GLP compliance, you can refer to the following resources.

Organization for Economic Cooperation and Development (OECD). The OECD’s website should be the first stop for organizations that must comply with GLP principles. There, you will find the principles themselves, as well as links to relevant websites and regulatory agencies.

European Commission. The European Commission’s website also offers a wealth of resources regarding GLP compliance for organizations operating throughout Europe. It also provides a list of all national bodies that monitor adherence to GLP principles, as well as a “Questions & Answers” document, which is linked above.

Food and Drug Administration (FDA). The FDA outlines GLP principles for organizations operating in the United States. It also provides links to the full principles required in the United States, the “GLP 101” document, and more.

ISO 9001 certification guide. AG5 offers a free certification guide for ISO 9001 – a standard organizations often use as a starting point when seeking to comply with GLP principles.

ISO 14001 certification guide. AG5’s free certification guide for ISO 14001 is also often integrated with GLP principles, and may prove useful to organizations.