Depending on your organization’s role in either biotechnology or drug discovery research, Good Laboratory Practices (GLPs) are the minimum standards used for benchmarking the proper conduct of animal safety studies, in a nonclinical environment, applying both in vivo and in vitro testing. GLPs provide a foundation for conducting well-controlled studies that can assure the quality and integrity of any data generated in the laboratory that may be used for future research studies or regulatory submissions. Not only do GLP regulations help ensure the quality of data, but they can also help to form a framework for facilitating study reconstruction when data is found favorable to moving forward with research on a new drug substance or product.  Since GLP regulations are typically used in the research laboratory, new compounds and drug substances must be first tested for safety via non-clinical studies.  Having this strong foundation of quality and regulatory awareness, even early in the research phase of development, can help to ensure data that is generated is of the highest quality leading to better and more effective research outcomes with novel products being brought to market.

(Learn more about the other compliance standards in our ultimate guide to GxP compliance, including Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP))

Certifications and Regulations

Regulatory certifications and specific GLP regulations for new products will depend on the region or country of the world where an organization wants to bring their product to market.  GLP certifications are another tool meant to help guide and ensure that laboratories adhere to stringent quality standards in their operations, particularly in areas like data integrity, personnel training, equipment calibration, and documentation. Because each region or country is unique, specific requirements can vary depending on the regulatory authority.  While GLP itself is a regulatory framework rather than a specific certification, several certifications are available to demonstrate compliance with GLP principles. These certification programs are provided to help ensure that a quality program can be created in an organization and maintained alongside the research being conducted. 

GLP certifications will vary depending on the regulatory body; however, in recent years, many of the organizations listed below have undergone significant efforts to harmonize requirements for certification:

1. ISO/IEC 17025: This is an international standard for testing and calibration laboratories. While not specific to GLP, ISO/IEC 17025 includes elements of GLP and ensures laboratories meet quality management system requirements.

2. FDA GLP Compliance Certification: Issued by the U.S. Food and Drug Administration (FDA), this certification indicates that a laboratory complies with FDA’s GLP regulations, ensuring the integrity and reliability of non-clinical laboratory studies.

3. OECD Principles of GLP Compliance: The Organization for Economic Co-Operation and Development (OECD) provides guidelines for GLP compliance monitoring. A laboratory can obtain certification indicating adherence to these OECD GLP principles.

4. EPA GLP Compliance Certification: In the United States, the Environmental Protection Agency (EPA) has its own GLP regulations. A laboratory may seek certification demonstrating compliance with EPA GLP standards.

5. MHRA GLP Certification: The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom offers GLP certification for laboratories conducting studies on pharmaceuticals and healthcare products.

6. CFDA GLP Compliance Certification: The China Food and Drug Administration (CFDA) provides GLP certification for laboratories conducting studies related to food and drug safety in China.

7. TGA GLP Compliance Certification: The Therapeutic Goods Administration (TGA) in Australia offers GLP compliance certification for laboratories involved in the testing of therapeutic goods.

As mentioned, different regulatory bodies are in the position of receiving and accepting regulatory submissions based on the region or location a product will need to be sold.  The most common markets and regulatory bodies are the FDA and the European Union (EU).

FDA and EMA/EU are the two we will focus on as they pertain to specific regulatory requirements since they are the two largest markets for new drug products.  Although significant efforts have been made to harmonize regulations across various regions, it is still imperative to verify each regulation and contact the regulatory body directly if any questions arise during the creation of a GLP program.

The FDA is considered the “gold standard” of GLP regulations, and many other regulatory bodies have worked to either mirror or implement various GLP recommendations laid out by the FDA.  Currently, 21 CFR Part 58 is the code of regulation that oversees GLP requirements.  This part prescribes good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products. Compliance with this part is intended to assure the quality and integrity of the safety data filed pursuant to the Federal Food, Drug, and Cosmetic Act and sections 351 and 354-360F and various other sections of the Public Health Service Act.

The European Union (EU) has a set of directives that form the guidelines for GLP for nation-states in the EU.  There are two main directives (regulations) that the EU has for GLP guidelines.  Directive 2004/9/EC outlines the obligation of EU countries to designate the authorities responsible for GLP inspections in their territories. The OECD also maintains a group for compliance monitoring and test facility inspections and audits.  Directive 2004/10/EC requires that countries take all measures necessary to ensure that laboratories carrying out safety studies on chemical products comply with the OECD principles.  Both directives are like the FDA regulations; however, differences are seen within the audit and facility requirements listed in both just to name a few.  

Compliance Strategies 

The first stage in implementing a new or revising an existing GLP program is to determine which market your new product may be marketed and sold.  As seen above, this will directly impact the regulations and how your GLP program should be organized.  It is vital to pinpoint the market and regulations early in the development process to be sure that the GLP program being developed can also grow in the future to fit the needs of the product and specific regulatory bodies.  The ultimate purpose of a GLP program is to ensure that all data generated in the laboratory is of the highest quality and to ensure that there is a positive culture of quality within an organization.  By creating a positive culture around quality and GLP procedures will cultivate an environment where a more effective and safer product for the public is achieved.

It may seem like a daunting task; however, there are universal recommendations and steps that any organization can take early on in development to create a concrete GLP strategy.  The following categories are intended to help provide a guide that any organization can follow to create a GLP compliance strategy irrespective of the regulatory body that will be granting eventual approval for a product.

  1. Organization and Personnel:  GLP regulations typically require that the structure of a research organization be clearly defined along with the unique roles and responsibilities of individuals.  GLP also stresses that there should be sufficient staff to perform the tasks required.  This might include looking at headcount, training, and facility needs that will have to be in place to support GLP in the laboratory. By employing a strategy of analyzing laboratory activities and requirements will help to provide tangible data on staffing levels and needs.
  2. Protocols, Written Procedures and Characterization: The main steps of a study or laboratory activity are the study plans or protocols.  Being able to repeat studies and obtain similar results is a central tenet of the scientific method.  Written procedures that are clear and concise to help guide laboratory activities, data recording and reports are also central to a well-defined GLP program.  Characterization will be essential for studies that evaluate the properties of pharmaceutical compounds during non-clinical studies.  Critical information about the chemical composition of said drug products should be obtained and incorporated into the GLP program.  An organization can employ current scientists and researchers to help write and organize procedures and protocols to ensure the proper transmission of ideas and information. 
  3. Results:  All studies generate raw data and as such this data should have requirements around reporting, acceptance, etc.  Final reports for all data studies should be created and archived along with various supporting documents and protocols. How to archive data and storage should also be included in a GLP program and is typically under the purview of the Quality Assurance or IT departments.
  4. Quality Assurance (QA):  As defined by GLP, QA “is a team of people charged with assuring the management that GLP compliance has been attained in the laboratory”.  The Quality Assurance unit MUST be independent in all aspects of operational studies being performed.  These individuals are typically formal laboratory staff with specific training in regulatory requirements.  Suppose there is not currently a Quality Assurance (QA) program or personnel in place at the time of study execution. In that case, it will be imperative to create a department dedicated to maintaining and controlling the documentation and training of personnel.  The size and scope of the QA department will depend on the size and scope of the research being conducted. 
  5. LIMS, ELN, and data management systems:  Programs and systems designed to be configurable, scalable, and science-aware platforms can help laboratories and Quality departments maintain control over various documents and automate processes within the laboratory.  Using state-of-the-art platforms can enhance the quality and traceability of data when dealing with GLP regulations and requirements. 

How Does Sapio Support GLP Compliance and Certification?

Sapio Sciences supports organizations in achieving GLP certification and compliance by offering comprehensive software solutions tailored to the specific requirements of GLP regulations and certifications.  Sapio’s science-aware software provides tools for managing regulatory compliance requirements, including those outlined in GLP regulations. The software helps organizations understand and adhere to the standards set forth by regulatory bodies such as the FDA, OECD, EPA, MHRA, CFDA, TGA, and others. Organizations can streamline the process of obtaining GLP certification by centralizing regulatory requirements and facilitating compliance management. The software can also enable the creation, management, and maintenance of documentation required for GLP certification, including Standard Operating Procedures (SOP), protocols, study plans, reports, and other essential documents. 

Sapio Sciences also provides LIMS and ELN solutions designed to meet the specific needs of laboratories operating under GLP regulations. These systems enable organizations to manage data, samples, workflows, and documentation in compliance with GLP requirements. By leveraging LIMS and ELNs, organizations can improve data integrity, traceability, and efficiency in their GLP-compliant operations. Sapio’s software prioritizes data management and security to ensure the integrity and confidentiality of laboratory data. The software offers features such as data encryption, access controls, audit trails, and data backup to safeguard sensitive information and comply with GLP regulations’ data security requirements.

(Read more about the features to look for when choosing LIMS and ELN software)

By offering these software solutions, Sapio Sciences empowers organizations to navigate GLP certification and compliance effectively. Sapio Sciences provides the necessary tools to establish and maintain a robust GLP program that meets regulatory standards and supports quality scientific research.