Crop Science

Bayer: Understanding Regulatory Science for Crop Protection

What are Good Laboratory Practices (GLPs) and why do they matter?

How does Bayer ensure the quality and integrity of its safety testing?

We understand that you might have questions around the process used to assess the safety of our products – and we’re listening. We are consumers just like you and our scientists uphold the strictest of standards in our research, such as Good Laboratory Practices (GLP), as we work to bring products to market.

What are GLPs?

Good Laboratory Practices (GLPs) are principles outlining how safety studies are planned, performed, monitored, recorded, reported and archived to maintain quality and integrity of study data that support regulated products.

GLPs are followed by test facilities carrying out studies to be submitted to regulatory authorities for the purposes of assessing the health and environmental safety of chemicals and chemical products.

The Organization for Economic Co-operation and Development (OECD) is an international organization that works with governments, policy makers and citizens to solve a range of social, economic and environmental challenges, while helping to define internationally recognized standards.

The European Food Safety Authority (EFSA) provides scientific advice and communicates on existing and emerging risk associated with the food chain. This advice, based on their gathering of scientific data and expertise, informs European laws, rules and policy making to protect consumers.

Codex Alimentarius, also known as “Food Code,” is a collection of standards, guidelines and codes of practices adopted by the Codex Alimentarius Commission. Codex standards are globally recognized and ensure that food is safe and can be traded.

Health Canada is a federal institution responsible for helping Canadians maintain and improve their health. They ensure high-quality health services are accessible and work to reduce health risks.

The Environmental Protection Agency (EPA) is an agency of the United States federal government whose mission is to protect human health and the environment. Their work includes enforcing laws and regulations to protect human health and the environment, ensuring access to accurate information on health and environmental risks, and reviewing chemicals in the marketplace.

The Organization for Economic Co-operation and Development (OECD) is an international organization that works with governments, policy makers and citizens to solve a range of social, economic and environmental challenges, while helping to define internationally recognized standards.

The European Food Safety Authority (EFSA) provides scientific advice and communicates on existing and emerging risk associated with the food chain. This advice, based on their gathering of scientific data and expertise, informs European laws, rules and policy making to protect consumers.

Codex Alimentarius, also known as “Food Code,” is a collection of standards, guidelines and codes of practices adopted by the Codex Alimentarius Commission. Codex standards are globally recognized and ensure that food is safe and can be traded.

The Environmental Protection Agency (EPA) is an agency of the United States federal government whose mission is to protect human health and the environment. Their work includes enforcing laws and regulations to protect human health and the environment, ensuring access to accurate information on health and environmental risks, and reviewing chemicals in the marketplace.

Health Canada is a federal institution responsible for helping Canadians maintain and improve their health. They ensure high-quality health services are accessible and work to reduce health risks.

Overarching international safety frameworks, supported by scientific principles, define testing standards used in safety studies and are set by organizations such as Codex and OECD. To gain product authorization, country-specific safety and data requirements must also be met. These are established by national regulatory agencies such as the EPA, EFSA and Health Canada. GLPs are the foundation of all safety studies submitted for regulatory approval.

Core Principles of GLP

At its core, these principles guide any GLP study to ensure quality, transparency and comprehensibility.

Responsibility and Liability

The test facility management, study personnel, study director and quality assurance specialists are responsible for the structure and completion of the study within the GLP standards. All personnel must be qualified with the appropriate education, training and/or experience.

Organization and Study Management

Studies must be clearly planned, conducted, reported and monitored from start to finish, with reviews and QA checks. Test facilities are regularly inspected by competent authorities as part of the GLP certification.

Documentation and Archives

The study must be clearly and thoroughly documented to ensure each step is retraceable, reliable and transparent, including (unexpected) deviations or (planned) changes during conduct. Upon study completion, for records retention, retrievability and study reconstructability purposes, all raw data for every study is archived.

Each GLP study consists of 3 steps:

Study
Plan/Protocol

The study plan/protocol defines why research is being conducted, what will be studied, who is involved (personnel must have a combination of education, training and experience to perforce assigned functions), when and where it will take place, and how it will be done. The study plan/protocol is reviewed prior to study initiation to ensure quality, completeness, and compliance with all applicable regulations.

Study
Execution

Each study is conducted according to the plan and standard operating procedures (SOPs) to ensure the integrity of the study. SOPs, such as the specific way to handle a measuring device, aim to achieve efficient, consistent and quality results. Studies include an in-phase inspection to verify study parameters and an independent quality assurance team performs a data audit. All data generated is recorded directly, promptly and legibly. No data is eliminated.

Final
Report

All details and findings of the study contribute to the final report, which is reviewed by appropriate personnel (including quality assurance (QA)) to ensure all methods, SOPs and results are reflected accurately. The study, including protocol, raw data and report, is then archived. The final study report is ultimately sent to the regulatory authorities as part of the regulatory dossier.

The study plan/protocol defines why research is being conducted, what will be studied, who is involved (personnel must have a combination of education, training and experience to perforce assigned functions), when and where it will take place, and how it will be done. The study plan/protocol is reviewed prior to study initiation to ensure quality, completeness, and compliance with all applicable regulations.

Each study is conducted according to the plan and standard operating procedures (SOPs) to ensure the integrity of the study. SOPs, such as the specific way to handle a measuring device, aim to achieve efficient, consistent and quality results. Studies include an in-phase inspection to verify study parameters and an independent quality assurance team performs a data audit. All data generated is recorded directly, promptly and legibly. No data is eliminated.

All details and findings of the study contribute to the final report, which is reviewed by appropriate personnel (including quality assurance (QA)) to ensure all methods, SOPs and results are reflected accurately. The study, including protocol, raw data and report, is then archived. The final study report is ultimately sent to the regulatory authorities as part of the regulatory dossier.

Did you know? GLP studies have checks and balances to ensure results are trustworthy and cannot be manipulated. Additionally, the archives must be stored in places that offer protection against water, fire and access by unauthorized persons.

Is the Data Trustworthy?

GLP studies have checks and balances including third party and regulatory assessors that verify the study’s process and results before being authorized for market. Internal and external inspections are regularly conducted for laboratories performing work and generating data on studies. Additionally, the data undergoes at least one quality control review by a qualified individual that is not involved with the direct generation of the data. All of this is an integral component supporting the rigorous planning and execution of safety studies to ensure data is reproducible, reliable, traceable and credible.

REPRODUCIBLE

The resulting data can be independently replicated.

RELIABLE

Data collection is consistently performed by all personnel.

TRACEABLE

All raw data are maintained and can be retrieved for review and study reconstruction.

CREDIBLE

All personnel meet the requirements of proper education, training and/or experience to perform the tasks.

Before a product is approved for use on the market, numerous safety studies are conducted to according scientific principles and quality standards mandated by global regulatory agencies. Up to 150 different studies are required per product to evaluate and demonstrate safety.

Regulatory bodies around the world protect and ensure the health of people, animals and the environment. Regulatory authorities such as the EPA conduct independent audits on companies’ processes and studies to confirm compliance with GLP standards.

Quality and integrity of our data is the foundation of product safety in agriculture.

Delivering on our mission depends on developing products that are safe and valuable to our customers when used as directed. Safety is our top priority and rigorous science conducted according to scientific principles and guidelines, such as the GLPs, ensures that the responsible use of products is tested appropriately for safety for people, animals and the environment.