Good Laboratory Practices (GLPs)
Good laboratory practice (GLP) ensures the safety, quality, and organization of pharmaceutical research. The practice is followed to maintain consistently high standards and comply with any regulations set by government agencies, internal company procedures, and international regulations, like the 3Rs. During the research process, each member of a team must perform their duties to the set quality assurance standards. This article highlights the most common good laboratory practice examples.
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8 Good Laboratory Practice Examples
8 Good Laboratory Practice Examples
The quality control department of a company oversees good laboratory practice. However, it is ultimately the responsibility of every member of staff involved with laboratory testing.
The 8 main good laboratory practice examples are:
1. Audit and Inspections
These must be performed routinely to check that procedures are being followed. Both internal and external audits are necessary to verify if the good practice system is working correctly and if it needs any modifications. Audits primarily cover research protocol, processes, and reporting. Inspections take place by external regulatory bodies such as the EMA (European Medicines Agency) and the FDA (US Food and Drug Administration).
2. Standard Operating Procedures
SOPs are the guidelines that inspectors and laboratories should follow. The procedures should be clearly written and easily accessible to all staff. In addition to the guidelines, a set of forms or documents should be available to record data. These should be consistent, easy to understand, and complete. The SOPs ensure standards are measured and being met. This establishes the efficient production and reliable research results.
3. Data Recording
Data recording includes what the test was, how it was performed, when it was carried out, and who did it. All data must be recorded correctly when it is produced to avoid errors. Staff should never rely on memory as the wrong data could be recorded and have serious consequences. This practice ensures traceability and correct record-keeping, whether paper-based or electronically.
Standard laboratory notebooks should be used, and data should be entered into computers in the correct format. Data should be clear and concise and readable for other staff. The laboratory’s generic terms should be used for clarity.