What is GLP? Understanding Its Importance in Research

June 13, 2025

Have you ever wondered how businesses guarantee that their products, whether medications, chemicals, or food additives, are safe for public use?

The truth is, without a reliable framework for testing, even the most minor oversight can lead to unforeseen risks.

This is where good laboratory practice (GLP) comes in. In 2025, 70% of corporate risk and compliance professionals report a shift from basic compliance to a more strategic approach, highlighting its importance as a core organisational strategy and governance tool.

This guide covers the importance of Good Laboratory Practice (GLP), its principles, role in regulatory compliance, and its impact on product safety. We’ll also explore key GLP guidelines, international standards, and their relevance across industries.

What is good laboratory practice (GLP)?

Good Laboratory Practice (GLP) is a set of principles ensuring the quality, consistency, and integrity of non-clinical laboratory studies. These studies, which involve chemicals, pharmaceuticals, food products, and other substances, must meet high standards before a product can be approved.

The role of GLP in ensuring data quality and integrity

The role of GLP is critical in verifying the reliability of test data. Here’s how it contributes to data quality and integrity:

1. Documentation and record Keeping

GLP requires detailed documentation of all testing steps, including methods, observations, and deviations. This validates that results can be traced and anomalies can be explained.

2. Control of laboratory conditions

GLP mandates controlling lab conditions, such as temperature and humidity, to reduce variability and improve reproducibility of results.

3. Personnel and training
GLP requires laboratories to have adequately trained personnel who are qualified to carry out specific tasks. Only skilled staff should perform experiments to ensure accurate and consistent testing.

4. Standard operating procedures (SOPs)
SOPs standardise procedures, minimising human error and ensuring that results can be reliably reproduced under similar conditions.

5. Independent audits
GLP encourages external audits to assess adherence to standards, identify weaknesses, and promote continual improvement in laboratory processes

GLP does play a key role in maintaining the consistency and reliability of laboratory studies. But why does it hold such relevance in regulatory contexts?

Why does GLP matter in regulatory compliance?

GLP upholds laboratory data quality, which is vital for regulatory compliance in the pharmaceutical, chemical, and wellness product industries. Before products reach the market, they undergo rigorous testing to prove safety and effectiveness.

GLP's impact on safety and efficacy testing

GLP is essential for products entering regulated markets, such as the US and EU, as it establishes rigorous standards for conducting safety and efficacy tests.

Key aspects of GLP in testing:

Thorough study design: Guides planning, documentation, and data analysis to prevent errors and overlooked risks.
Controlled procedures: Maintains consistency in testing methods for trustworthy outcomes.
Regulatory compliance: Ensures products meet approval standards for market entry.

Also read: Understanding GLP-1: Meaning, Benefits, and Functions

How do GLP test results meet regulatory standards?

For wellness brands seeking approval, GLP is a must for meeting regulatory requirements from agencies like the FDA, EMA, and other global authorities. It ensures test results are consistent, reproducible, and accurate.

Here's how it facilitates compliance:

1. Standardisation of testing procedures
GLP standardises testing procedures across all phases, ensuring consistency and making it easier for regulators to verify the reliability of data.

2. Rigorous documentation
GLP requires thorough documentation of every step, allowing regulators to trace testing processes and assess the validity of data, including any deviations.

3. Transparency and traceability
A good laboratory practice makes every step of the testing process transparent and traceable, so regulatory bodies can follow the study from start to finish.

4. Independent verification
GLP promotes independent audits and reviews, ensuring that testing is impartial and data integrity is maintained, which is necessary for regulatory approval.

Also Read: Do GLP-1 Supplements Work Naturally for Health?

At The Good Bug, we offer GLP-compliant testing services to help wellness brands validate the safety and efficacy of their products before market release. Our testing supports regulatory compliance, offering peace of mind for pharmaceuticals, supplements, and food additives. Contact our experts today!

Now, let’s explore the key principles of GLP, as defined by the OECD, which form the crux of these regulatory processes.

Key principles of GLP as defined by the OECD

The OECD defines GLP principles to ensure the reliability, reproducibility, and scientific validity of laboratory studies.

OECD GLP principles and their global applicability

The OECD's principles are widely recognised and applicable to non-clinical studies, including testing chemicals, pharmaceuticals, and food additives.

Key areas addressed by OECD GLP:

Organisational responsibilities: Establishes proper management and accountability in the laboratory.
Study management: Standardises study design, execution, and monitoring.
Equipment and facilities: Confirms that laboratory equipment and facilities meet required standards.
Documentation: Guarantees accurate and consistent recording of data.

Adopting these principles guarantees that data meets regulatory expectations across different regions, promoting consistent and internationally accepted testing practices.

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Importance of study protocols, documentation, and QA in GLP

One of the instrumental aspects of GLP is the emphasis on comprehensive study protocols, meticulous documentation, and a trusted quality assurance system.

Let’s explore each of these critical components:

1. Detailed study protocols
GLP requires a detailed study protocol outlining objectives, methods, and procedures. This promotes consistency and minimises errors, making the study transparent, reproducible, and validating results.

2. Meticulous documentation
All study aspects must be accurately recorded, including design, methods, results, and deviations. This documentation supports traceability, audits, and bolsters confidence in regulatory submissions.

3. Quality assurance (QA)
QA verifies compliance with GLP standards. A dedicated QA unit reviews records, procedures, and data, identifying errors early to maintain study integrity and provide reliable data.

4. Traceability and accountability
GLP emphasises traceability, linking every action and result to a specific individual or procedure. This establishes accountability and facilitates the quick identification of discrepancies in the study.

5. Consistency in testing
The consistency of testing is another critical aspect of GLP. By establishing standard operating procedures (SOPs) for every aspect of the study, from equipment calibration to sample handling, GLP guarantees that results are consistent.

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The OECD's principles outline the fundamental guidelines for maintaining quality and consistency in laboratory studies.

Building on this, it’s essential to understand the major components that define GLP in practice.

What are the major components of GLP?

The key components of GLP include defined roles, strict equipment and facility standards, standard operating procedures (SOPs), and proper documentation.

Let’s break them down:

1. Responsibilities of the study director and QAU

The study director and the quality assurance unit (QAU) are key to maintaining GLP compliance. Let’s look at their specific responsibilities in detail:

Study director: The study director oversees the study’s design, execution, and final report, maintaining compliance with GLP standards. They manage study plans, testing procedures, and data integrity.
Quality assurance unit (QAU): The QAU verifies GLP compliance by independently reviewing the study from planning to execution. They monitor adherence to GLP guidelines, perform audits, and document deviations.

2. Requirements for facilities, equipment, and SOP

Facilities, equipment, and standard operating procedures (SOPs) are critical for maintaining GLP compliance.

Below, we outline the key requirements for these components:

Facilities: GLP requires facilities to be suitable for testing, with proper space, resources, and environmental controls, and regularly inspected to prevent contamination.
Equipment: All equipment must be maintained, calibrated, and checked for accuracy, with calibration records kept and verification before use to confirm reliable results.
Standard operating procedures: SOPs are developed, documented, and updated to promote consistent study execution, maintaining uniformity and minimising variability.

3. Study protocols and documentation for GLP compliance

Study protocols and documentation are imperative for GLP compliance. Proper design and standards enable transparency and accountability in research. Here’s a look at their importance in GLP:

1. Study protocols
The study protocol outlines procedures, objectives, and responsibilities and must be approved before the study's commencement. Any changes must be documented and justified to ensure systematic execution and reproducible results.

2. Documentation standards
GLP requires detailed, signed, and dated records of all study steps, with secure storage for easy access and auditing to ensure study integrity and regulatory compliance.

Also Read: Current Trends in GLP-1 Clinical Trials

As GLP is increasingly adopted globally, let’s examine how these standards are accepted across borders through the Mutual Acceptance of Data (MAD) principle.

Global adoption of GLP and MAD

Global adoption of GLP promotes trustworthy, high-quality non-clinical studies, facilitating international regulatory cooperation. The mutual acceptance of data (MAD) system allows companies to meet regional requirements without repeating tests, saving time and resources.

Let’s explore how GLP has improved global testing and removed trade barriers:

GLP’s role in international testing and MAD

The adoption of GLP has streamlined approvals by enabling the collection of internationally comparable data through uniform laboratory standards. Key benefits include:

Consistency across regions: GLP verifies that studies conducted in different regions, such as the U.S., Europe, or Japan, adhere to the same high standards.
Global adoption: OECD GLP principles have been widely adopted by regulatory authorities worldwide, creating a common understanding of testing methods.
Mutual acceptance of data: Data generated in one country is recognised and accepted by regulators in other countries, reducing the need for redundant studies.
Efficient approvals: Companies can conduct tests in one region, knowing their data will be accepted by regulatory bodies across multiple areas, speeding up approvals.

This global alignment benefits industries like pharmaceuticals, chemicals, and healthcare, where approval from multiple regulatory agencies is often needed.

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How GLP Avoids Test Duplication and Trade Barriers?

GLP allows data from tests conducted once to be used across multiple countries, eliminating the need for repetitive testing. It simplifies the regulatory process and removes trade barriers by standardising testing requirements globally.

Here’s how GLP benefits industries:

1. Avoiding duplicating tests: GLP enables mutual acceptance of data across countries, reducing costs, speeding up product approval, and improving efficiency.

2. Promoting efficiency: Adhering to GLP ensures that companies submit reliable data, allowing regulatory agencies to focus on scientific validity and expedite reviews.

3. Eliminating trade barriers: GLP harmonises testing standards, simplifying entry into international markets by eliminating differing regulatory requirements.

The global adoption of GLP and the Mutual Acceptance of Data (MAD) enables data from one country to be accepted internationally, thereby strengthening global regulatory processes.

Key industries where GLP is crucial for compliance

Three industries where GLP is particularly pertinent are pharmaceuticals, medical devices, and agribusiness. Each of these sectors depends on GLP to maintain trust in their products, meet regulatory requirements, and protect consumer safety.

GLP's Relevance in Pharma, Medical Devices, and Agribusiness

Let’s explore GLP’s impact on each of these industries.

1. Pharmaceutical industry
GLP governs non-clinical studies to confirm the safety and effectiveness of drugs, meeting regulatory standards established by organisations such as the FDA and EMA. It promotes transparency, facilitating regulatory approval and fostering public trust.

2. Medical device industry: It verifies the safety and reliability of medical devices, from bandages to pacemakers. It also guarantees thorough, repeatable testing that meets global regulations, reducing product failure risks and supporting real-world safety.

3. Agribusiness industry
GLP is useful for testing pesticides, fertilisers, and GMOs, ensuring safety for human health and the environment. It provides consistent data and regulatory compliance, confirming product safety.

GLP in global health assessments and product safety

GLP provides reliable, standardized data that supports regulatory collaboration and speeds up product approvals in pharmaceuticals, medical devices, and agribusiness.

1. Global health assessments: GLP provides high-quality data that supports global health assessments, helping regulatory bodies evaluate safety and fostering international collaboration, reducing approval delays.

2. Product safety studies: It verifies that product safety studies in pharmaceuticals, medical devices, and agribusiness follow strict protocols and accurate documentation for human and environmental safety.

GLP helps identify potential hazards, side effects, or environmental impacts, providing reliable data for regulatory approval. It prevents test duplication, saving costs and speeding up product approval. By establishing international standards, GLP promotes data acceptance across borders, supporting global trade and regulatory cooperation.

Adopting GLP builds trust between businesses, consumers, and regulators and guarantees consistent, high-quality results. It also organises testing procedures, reduces time-to-market, and strengthens product credibility in the global regulatory environment.

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