Introduction
Laboratories that are used in the quality process can be subject to good laboratory practice (GLP) which is a quality system that refers to a quality system of management controls. The first GLP regulations were instigated in 1978 by the Foods and Drug Administration (FDA) in the US. Other GLP regulations have been introduced by the Environmental Protection Agency in the US and the Organization for Economic Co-Operation and Development (OECD) in 1992.
The OECD describes GLP as “a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.” The basics of GLP are considered to be a set of standards that ensure the quality, reliability and integrity of studies, the reporting of verifiable conclusions and the traceability of data.
GLP regulations fall under five main areas;
- Resources
- Characterization
- Rules
- Results
- Quality Assurance
Resources
The GLP regulations concerning personnel number requires that there must be laboratory staff available to perform the tasks required in a timely manner and comply with regulations. The GLP requires that the qualifications of personnel be recorded and that they maintain adequate levels of competence, for example through continuing education.
The regulations on resources also relate to the facilities where the laboratory is located and equipment used. The laboratory should have adequate space to perform the quality inspections required so that there is no opportunity for errors due to cross contamination or lack of storage. GLP regulations require that the equipment should be regularly maintained and calibrated, with all the necessary records to show compliance. Although resources account for around 15 percent of GLP regulations they are the source of a larger percent of non-compliance.
Characterization
Characterization refers to the test items and the test systems. The GLP regulations require that personnel know details about the study to be performed. It is a prerequisite to have detailed knowledge about the properties of the test item and understand the characteristics such as stability, composition, identity, potency, impurity profile, etc.
Rules
The regulations regarding rules refer to the protocols and standard operations procedures (SOP) used. The protocols used in a study refer to the planned steps that will be taken and to ensure that those steps are in compliance with GLP. The study has to document the standard operations procedures (SOP) so that if the tests need to be replicated they can be using the SOP’s. The GLP requires that the SOP’s are used so that the results can be compared against other tests on other samples using the same SOP’s.
Results
The tests will produce raw data that is collected during the testing. These are the results of the tests that were performed on the sample. The data is stored on a system such as a LIMS system which can be accessed by laboratory staff or interfaced to another system. All computer systems that are used have to undergo a process called validation, which means that the system must perform tasks as documented. The validation of computer systems can include LIMS systems and ERP systems. There are specialized companies that perform validation services if there is not sufficient experience in-house.
Quality Assurance
The GLP regulations require that there are quality assurance personnel to monitor and ensure that the facility is compliant with GLP. The quality assurance personnel will perform audits and inspections of facilities. They will review protocols, SOP’s, and the results of previous inspections. The audit will review personnel records, computer operations and security, as well as general security of the facility. The quality assurance team can also audit contractors and suppliers if required.
Summary
The good laboratory practice (GLP) regulations can be applied to laboratories in a number of industries, such as cosmetics, food, chemicals, pesticides, medicines, and biocides. The GLP regulations offer common sense and standardization of documentation to laboratories and laboratory procedures. Good Manufacturing Practices have been adopted in the US, the European Community, OECD nations, and many other countries such as Japan, Israel and Switzerland.
