The Benefits of GLP Testing: Enhancing Accuracy and Accountability in Scientific Studies
The biomedical industry conducts multiple health-associated clinical assessments to test new compounds and develop therapeutic products. This testing approach often involves dangerous substances and methods requiring environmental and regulatory compliance to protect the environment and public health.
The OECD is an international agency comprising numerous nations with a primary goal to foster international economic progress and resolve issues around world trade. Among its duties is implementing and monitoring good laboratory practices (GLP) for studies that drug developers and medical companies should comply with. The current article discusses different aspects of GLP testing and its benefits in enhancing accuracy and accountability in scientific studies.
What is GLP testing?
Good laboratory practices are a quality control system corresponding to the organizational conditions and processes under which multiple environmental and nonclinical studies are designed, conducted, recorded, monitored, and reported. Clinical testing laboratories conducting research studies such as BABE testing and pharmacokinetics assays must report the safety of clinical studies to appropriate authorities. GLP testing requirements need to meet obligations around exploratory and clinical studies such as:
- Researchers should maintain the testing equipment and facilities for undergoing studies.
- Standardize and document laboratory practice, regulations, and operating procedures.
- Collect the reports and data of daily operations.
- Adequate training and accountability of facility staff, including management teams and quality assurance specialists.
Good laboratory practice was first initiated under the US FDA but has expanded to several countries through the OECD. The primary elements of GLP testing include:
- Standard operating systems: a step-by-step process to document protocols and instructions.
- Data recording: capturing and recording all study data. Direct and prompt recording of data with signed or initialed systems.
- Correct equipment use: periodic inspections, cleaning, monitoring, and calibration of study equipment.
- Tested items: proper labeling of chemicals, solutions, and reagents to indicate storage conditions, identity, and expiry date.
- Staff and training: each staff member should have a thorough understanding of their roles and adequate training in GLP practices.
- Facilities: test laboratory with suitable size, location, and construction to meet all study requirements.
- Audit and inspections: routine monitoring, external and internal, to ensure compliance with practices and identify necessary study modifications.
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Benefits of good laboratory practices
Ensuring the quality of test data for studying the effects of chemical and drug products on health and the environment is critical for comparing them across countries and making them acceptable. This approach prevents unnecessary use of animal models, test repetitions, time and resource wastage, and robust exchange of experimental data among nations. Reliability and quality, the foundations of GLP testing, are necessary for a streamlined exchange and acceptance of study data among regulatory agencies.
Apart from domain-specific biomedical testing, GLP compliance is necessary for nonclinical drug development, biocidal product development, toxic chemical production, agricultural pesticide development, and food additives development. Besides, GLP testing is integral in cosmetic product development and testing of explosive products.
A laboratory with efficient GLP compliance keeps a paper trail of data and measurements to ensure smooth backtracking of all figures and results whenever necessary. After generating experimental findings, GLP compliance can help verify conclusions using processes and empirical data, instilling confidence in the result.
A laboratory performs studies with the primary goal of generating results that could help develop novel drug compounds and treatments. This generated data is considered more robust and reliable when conducted under GLP compliance. GLP testing adds more confidence in findings and results, reducing unnecessary regulatory compliance investigations. It increases lab productivity by generating robust data and minimizing false findings. Most importantly, GLP testing enhances the reputation of a bioanalytical laboratory.
GLP systems offer multiple advantages to bioanalytical and drug development laboratories. The reliability data of chemical compounds and products used in the industry offer the prerequisite reliability and quality requirement of mutual recognition among countries and regulatory agencies. Hence, the quality of test results addresses the vital issue of comparing the environmental and health impact of drug products and chemical compounds among countries. Besides, GLP testing ensures the efficient use of resources and investments by minimizing unnecessary repetition and experimentation and reducing the use of animal models.
The ultimate advantage of robust biomedical testing leads to an improved time to bring new pharmaceutical products to the market. Instead of wasting resources and time with additional testing and ineffective studies, GLP testing ensures that researchers have all the necessary data to generate conclusive results.
Instilling GLP training and values in laboratories
GLP implementation is an elaborate process. It requires collaboration among laboratory staff and forward-thinking to achieve ideal GLP methods and systems. For example, a robust quality management system is needed to meet basic requirements, including operating protocols, documenting data, routine calibration, and cleaning of measuring equipment and tools.
Moreover, every staff member must be on the same page. All members, including upper board management, individual staff members, and employees, should have the required experience and knowledge of GLP processes. These initiatives are necessary to identify potential issues and resolve them to guarantee compliance.
