In the weighing industry, you’ll often see the term “GLP-compliant.” GLP stands for Good Laboratory Practice but what does it actually mean?
GLP, which was first introduced in 1972, is a quality assurance system used by laboratories and other organizations to ensure consistency, integrity and reproducibility in non-clinical study and test data. (Clinical studies utilize Good Clinical Practices, the Declaration of Helsinki and other regulations that protect the safety of human participants.) GLP regulations aren’t concerned with the content (scientific or technical) of the research or evaluate the value of the studies – they are simply about quality assurance.
A frequent selling point for laboratory balances like Adam Equipment’s analytical and precision balances is that their printouts are GLP compliant. Among other things, this means that they include certain details for data tracking.
What Does GLP Encompass?
The five main points of GLP are:
- Resources. The responsibilities of research personnel must be clearly defined, and their qualifications and training must be documented. Equipment must also be in proper working order, following a program of qualification, calibration and maintenance.
- Characterization. It’s essential to know as much as possible about the materials used within the study (i.e., the test item and the test system).
- Rules. Each test should be conducted using protocols (providing the design and timeframe) and written standard operating procedures to ensure that results are repeatable.
- Results. The raw data must reflect the procedures and conditions of the study, while the final report – which is provided to regulatory authorities – must include an account of the way the study was performed, along with the scientific interpretation of the data. Easily accessible archives of the original data must also be maintained for many years.
- Quality assurance. GLP requires a team of independent personnel to be assigned to a study to assure compliance with GLP standards.
How Does GLP Affect Balances and Scales?
GLP regulations cover equipment, including the suitability for a study: an analytical balance with a readability of 0.0001g, for example, would be unnecessary for a scientist tracking the weekly weight of a mouse. Under GLP guidelines, a study director would define the suitability of the equipment, though with analytical equipment, oftentimes it’s necessary to conduct formal tests or qualifications as part of the selection process.
Balances must also be calibrated for use in studies, with the frequency of calibrations defined as part of the standard operating procedures mentioned above. Documentation of calibration and other equipment tests must also be retained.
Printouts for purposes of quality control, data tracking and traceability are an important component of GLP. To make them GLP compliant, printouts should include such information as time, date and the weighing device’s ID. Many of Adam’s balances – including the Equinox, Eclipse and Solis lines – offer GLP-compliant output that can be printed via thermal or impact printers.