What are the Principles of Good Laboratory Practice?
The phrase “GLP compliant” often comes up while shopping for lab equipment. Maybe you’ve wondered what that meant. Let’s take a look at GLP – short for Good Laboratory Practice – and talk about how it applies to your lab.
What Do We Mean by Good Laboratory Practice?
GLP isn’t so much a system of rules or protocols so much as a set of guidelines to ensure consistency, reliability and reproducibility in non-clinical studies and test data. (Clinical studies use different standards, including Good Clinical Practice. Manufacturers also use a set of guidelines like GLP, called Good Manufacturing Practice.) GLP doesn’t evaluate the value of a study – it simply ensures that the study is conducted properly to get the best-quality data. Put simply, Good Lab Practices are put in place as a system of quality assurance.
Stemming from safety concerns, the regulatory concept of GLP originated in the U.S. with the Food & Drug Administration in 1972. Today, labs that make or test products like food additives, biologicals and medical devices are subject to the FDA’s Code of Federal Regulations for GLP for Nonclinical Studies.
Regardless of industry or type of lab, here are five main standard areas for Good Lab Practice:
- Resources: Research personnel and equipment. For personnel, this includes defining the responsibilities of members of the research staff, as well as documenting their qualifications and training. For equipment, this ensures that it’s in proper working order through a program of qualification, calibration and maintenance.
- Characterization: Data regarding both the test item and the test system
- Rules: Testing that uses protocols (including the design and timeframe) and written Standard Operating Procedures (SOPs) to ensure that results are repeatable
- Results: Raw data (reflecting the procedures and conditions of the study), Final report (provided to regulatory authorities, including an account of how the study was performed, along with the scientific interpretation of the data) and Archives (easily accessible archives of the original data that must be maintained for many years)
- Quality Assurance: Independent monitoring of research processes by a team of independent personnel who assure compliance with GLP standards
What are the Benefits of Good Laboratory Practice?
The primary benefit of GLP is data integrity. Without trustworthy data and repeatable results, all testing may be called into question. Science requires apples-to-apples comparisons. Standardized testing protocols and equipment maintenance standards mean that research can be built upon a solid, trusted foundation. Compliance with GLP can also safeguard against fraud.
How Does GLP Apply to Sonic Supply’s Products?
Many of Sonic Supply’s offerings would be classified as lab equipment. As such, GLP guidelines for equipment apply.
One of the most important considerations is choosing the right tool for the right job! Your lab equipment should be suitable for your intended use (i.e., appropriate equipment of adequate capacity). How do you know if it's suitable? Think about the task it’s expected to perform. If you’re weighing lab mice, for example, you’re unlikely to need a semi-micro analytical balance. Typically, your SOPs help determines the equipment’s suitability.
Equipment – whether it’s used to generate data (analytical equipment or balances) or maintain standard conditions (refrigerators) – must be calibrated and maintained to ensure accuracy and reliability. For calibrations, lab balances use calibration weights. Adherence to GLP also requires recordkeeping to track repairs and maintenance (routine, preventative, curative or otherwise), and ensure the equipment is within its operational lifetime or service intervals.
Part of GLP compliance is also traceability. With products like lab balances, this means their printouts need to include details such as date, time and the weighing device’s ID for data tracking.
For more information on Good Laboratory Practice and international guidelines, check out the World Health Organization’s Good Laboratory Practice Handbook.
If you have any questions about Good Lab Practises and compliance for Sonic Supply’s products, call or email us. We’re here to help!
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