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.
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.
4. Correct Use of Equipment
Use of the wrong or uncalibrated equipment could present inaccurate data. The equipment type and recalibration should be carried out before any test takes place. The specified instruments and equipment should be well-maintained according to a specified program and only used as intended. This helps deliver reliable data and prevents data loss. Records of equipment maintenance should be kept.
5. Test Items
Test material should be labeled and stored at all times at the correct conditions including temperature, light/darkness, and humidity. The sample should carry the date, study details, batch number and any other required information set out in the procedures.
Only staff qualified to carry out particular testing procedures should do so. Staff should understand their role and have a job description. Records of staff qualifications and training and development should be kept. A pharmaceutical research study is usually overseen by a study director, who is responsible for the results of the study. It is their role to check correct practice is followed and to sign off the results at the end of the study.
7. Correct training
Training is an essential part of good laboratory practice examples. Staff involved in laboratory work must understand the practices to be followed and why they are important. This applies to the training of new staff and refresher training for existing staff to remind them of testing, analysis, and reporting practices as well as introducing new ones.
All testing should be carried out in a laboratory designated for the purpose. The atmosphere should be at the correct temperature, there should be enough space to work, sites should be clean before and after the test and cross-contamination protocols should be observed. Staff should wear correct laboratory clothing and relevant PPE (personal protective equipment) at all times.
Good laboratory practice is required to avoid mistakes and make sure everyone is following the same rules. This leads to the production of accurate and quality data that can be used in the development of drugs to prevent and fight human disease. These good laboratory practice examples should be employed to produce successful research outcomes.