Good laboratory practice

What Is Good laboratory practice?

Good laboratory practice (GLP) refers to a set of principles and a quality system that governs the organizational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported. This framework falls under the broader umbrella of Regulatory Compliance in industries where the reliability and integrity of scientific data are paramount. The primary aim of good laboratory practice is to ensure the consistency, reliability, quality, and integrity of non-clinical safety data submitted to regulatory authorities for the assessment of products. These products can range from pharmaceuticals and pesticides to cosmetics and food additives, ultimately impacting Public Health and Consumer Protection.

History and Origin

The origins of good laboratory practice regulations in the United States are rooted in concerns over the reliability of data submitted to regulatory agencies in the 1970s. A notable scandal involved Industrial Bio-Test Laboratories (IBT), which was found to have submitted unreliable or falsified toxicology data to the Food and Drug Administration (FDA) on behalf of pharmaceutical companies and others. This widespread misconduct and lack of adherence to proper scientific standards led to public outcry and congressional hearings¹³, ¹⁴.

In response to these findings, the U.S. Food and Drug Administration (FDA) proposed the first GLP regulations in 1976, aiming to standardize procedures and ensure data integrity in non-clinical safety studies. The final rule, 21 CFR Part 58, was officially established in June 1979¹¹, ¹². Other countries and regulatory bodies, such as the Environmental Protection Agency (EPA) in the U.S. and the Organisation for Economic Co-operation and Development (OECD), subsequently developed and adopted their own GLP guidelines. The OECD Principles of Good Laboratory Practice, first adopted in 1981 and revised in 1997, play a crucial role in promoting the mutual acceptance of safety data among member countries, fostering international harmonization in the testing of chemicals and chemical products⁹, ¹⁰.

Key Takeaways

• Good laboratory practice (GLP) is a quality system for non-clinical laboratory studies, ensuring data integrity and reliability.
• It applies to studies supporting regulatory submissions for products like drugs, chemicals, and medical devices.
• GLP principles cover all aspects of a study, from planning and execution to monitoring, recording, and archiving.
• Compliance with GLP helps validate safety data, expedites regulatory approvals, and builds confidence in scientific findings.
• The framework was developed in response to instances of fraudulent or poor-quality data in non-clinical research.

Interpreting the Good laboratory practice

Good laboratory practice serves as a foundational standard for interpreting the validity and reliability of scientific data derived from non-clinical studies. When a study is conducted under GLP, it signifies that the research was performed according to a stringent set of guidelines covering personnel, facilities, equipment, written protocols, and comprehensive record-keeping. This adherence means that the data produced are considered verifiable and credible, which is critical for regulatory bodies evaluating the safety of a product before it reaches the market. For stakeholders involved in Investment Analysis, particularly in sectors like Pharmaceuticals or Biotechnology, GLP compliance provides a crucial assurance regarding the robustness of preclinical safety data. It suggests that the underlying Research and Development has met a globally recognized standard for quality and trustworthiness, reducing uncertainty about future regulatory hurdles.

Hypothetical Example

Imagine a biotechnology firm, "BioAdvance Corp.," developing a new compound intended to treat a rare disease. Before BioAdvance can begin Clinical Trials involving human subjects, they must conduct extensive non-clinical safety studies on the compound in animal models.

To ensure the integrity and acceptance of these studies by regulatory authorities, BioAdvance's toxicology laboratory operates under good laboratory practice (GLP) principles. This means:

1. Protocol Development: A detailed study plan, or protocol, is written, outlining every step of the study, from animal selection and dosing regimens to data collection and statistical analysis.
2. Personnel and Facilities: Only trained and qualified staff are involved in the study, and the laboratory facilities are designed to prevent contamination and ensure proper environmental controls for the test animals.
3. Equipment Calibration: All equipment used for measuring doses, animal weights, or analyzing samples is regularly calibrated and maintained, with detailed records kept.
4. Data Recording: Every piece of raw data, from daily observations of animals to blood test results, is meticulously recorded, dated, and signed, ensuring complete Data Integrity.
5. Quality Assurance Unit (QAU): An independent QAU within BioAdvance monitors the study to ensure compliance with the GLP regulations and the approved protocol, performing regular Audit functions.

By adhering to good laboratory practice, BioAdvance can confidently submit its non-clinical safety data to regulatory bodies. This adherence demonstrates that the data are reliable and suitable for evaluating the compound's safety profile, paving the way for the company to proceed with human clinical trials and, eventually, seek marketing approval.

Practical Applications

Good laboratory practice is critical across several industries, particularly where products impact human or environmental health. Its primary application lies in the non-clinical safety testing of new chemical entities, drugs, medical devices, food additives, and cosmetics. For instance, in the pharmaceutical industry, GLP is essential for studies assessing the toxicity and pharmacokinetic profiles of drug candidates before they can progress to human testing. Compliance helps companies meet the stringent requirements of regulatory agencies like the FDA (U.S.) and EMA (Europe), which in turn can expedite the drug approval process⁸.

Beyond pharmaceuticals, GLP applies to agrochemicals, industrial chemicals, and veterinary drugs, ensuring that environmental and animal safety assessments are robust and reliable. Companies leverage GLP to ensure the reproducibility and traceability of their research findings, which is vital for effective Risk Management and compliance within the heavily regulated financial markets. Adherence to GLP standards helps maintain scientific validity and integrity, providing sound evidence for regulatory evaluation⁷. This systematic approach fosters high-quality Quality Assurance in laboratory settings.

Limitations and Criticisms

While good laboratory practice significantly enhances the reliability and integrity of non-clinical data, it does have limitations. One common critique is the perception that strict adherence to GLP can be time-consuming and resource-intensive, potentially increasing the cost and duration of Research and Development activities. The extensive documentation requirements, facility standards, and personnel training necessary for GLP compliance can be particularly challenging for smaller organizations or academic laboratories not typically operating under such rigorous Market Regulation.

Furthermore, GLP focuses primarily on the quality and integrity of data generation, not necessarily on the scientific merit or relevance of the study design itself. A study can be GLP-compliant yet still be poorly designed or answer an irrelevant question. This distinction is important for [Due Diligence] (https://diversification.com/term/due_diligence). Another concern can arise from non-compliance, which can lead to severe consequences for laboratories and companies. Such failures can result in the rejection of study data by regulatory authorities, requiring costly repeat work, leading to product recalls, and even facing criminal prosecutions, especially if fraudulent activity is involved or public health is endangered⁶.

Good laboratory practice vs. Good Manufacturing Practice

Good laboratory practice (GLP) and Good Manufacturing Practice (GMP) are both critical quality systems within regulated industries, but they apply to different stages of product development and production.

While GLP ensures that the data used to prove a product's safety are sound, GMP ensures that the product itself is consistently produced to high-quality standards. For example, a new drug candidate would undergo GLP-compliant non-clinical safety studies. If approved for human use, its subsequent large-scale production would need to adhere to Good Manufacturing Practice regulations to ensure every batch is safe and effective.

FAQs

What types of studies require Good laboratory practice compliance?

Good laboratory practice compliance is typically required for non-clinical laboratory studies that generate data intended to support applications for research or marketing permits for regulated products. This includes studies evaluating the safety of human and animal drugs, biological products, medical devices, food additives, color additives, and certain electronic products⁵. These studies often involve toxicology, pharmacology, and other safety assessments conducted in laboratory settings.

Who enforces Good laboratory practice regulations?

In the United States, the Food and Drug Administration (FDA) is a primary enforcer of good laboratory practice regulations (21 CFR Part 58) for products it regulates⁴. Similarly, the Environmental Protection Agency (EPA) enforces GLP for chemical substances and pesticides. Internationally, the Organisation for Economic Co-operation and Development (OECD) develops and promotes GLP principles to facilitate the mutual acceptance of safety data among its member countries, and national authorities are responsible for monitoring compliance within their territories², ³.

Can a study be scientifically sound but not GLP compliant?

Yes, a study can be scientifically sound and produce valid results without being GLP compliant. Good laboratory practice is a regulatory framework ensuring data integrity and reliability for submission to authorities, not necessarily guaranteeing the inherent scientific quality or novelty of the research. Basic research, academic studies, or early-stage exploratory studies often do not adhere to GLP unless their data will be submitted for regulatory approval¹. However, for data used in formal safety assessments, GLP compliance is typically a prerequisite.