“Good Laboratory Practice (GLP) is concerned with the organizational process and the conditions under which laboratory studies are planned, performed, monitored, recorded, and reported.”
GLP prescribes a laboratory to work according to a system of procedures and protocols. This implies the organization of the activities and the conditions under which these take place are controlled, reported and filed. GLP is a policy for all aspects of the laboratory which influence the quality of the analytical work. When properly applied,
GLP allow better laboratory management including quality management to improve
- Efficiency (reducing cost)
- Minimize errors
- tracking of errors and their cause
- stimulate and motivate all personnel
- improve safety
- improve communication possibilities
The outcome of Good Laboratory Practice (GLP) is an enhancement in laboratory performance and effective operational control. A significant factor is the documentation of quality standards, which can be presented to regulatory bodies and clients. This leads to an elevated reputation for both the laboratory and the institution overall.
In summary, the key message is:
articulate your actions, execute them as stated, improve upon them, and provide evidence of your achievements.
The fundamental principle is to ensure that all pertinent plans, activities, conditions, and situations are documented, securely stored, and readily accessible when required. Each of these elements varies significantly in nature and must be addressed separately.
The documents collectively form what is referred to as a Quality Manual. This manual encompasses all pertinent information regarding:
- Organization and Personnel
- Facilities
- Equipment and Working Materials
- Analytical or Testing Systems
- Quality Control, and
- Reporting and Filing of Results.
Due to the diverse nature of institutions with laboratories, there is no universal format, and each must develop its own Quality Manual. The current Guidelines provide examples of forms, protocols, procedures, and hypothetical scenarios. These will require adaptation, and many new documents will need to be created to meet specific requirements; however, all must adhere to the fundamental criteria of being useful and verifiable.
Premises:
- Maintain laboratory and its premises clean.
- Clean and disinfect the sterile and microbiological testing area.
- Maintain all equipment/instrument clean and to the extent possible covered.
- Maintain all analytical balances on a steady platform, away from air current and vibration.
- Measure the temperature of laboratory at least twice in a day.
- Keep workbench of laboratories clean and tidy all time.
- Ensure only current version of all master document are available in the laboratory.
- Ensure all equipment/instrument are qualified as per relevant protocols before putting into use.
- Allot identification number to all analytical instrument/equipment.
- Maintain all instrument/equipment in calibrated status.
- Identify “Under Maintenance” instrument/equipment and prevent usage of same.
- SOPs and logbook must be maintained at the workplace where it can be easily accessed.
- Ensure all liquid/gas chromatography column are numbered as per procedure.
Personnel:
- Always wear the company uniform or apron as applicable in the laboratory premises.
- Do not drink and eat in the lab.
- Follow entry exit procedure wherever applicable.
- Follow safety instruction carefully all the time.
- Wear safety apparels and equipment as applicable in the laboratory premises.
Practices:
- Analyst shall perform analysis of sample after they are qualified and certified as per procedure.
- Update the daily analytical work plan and status on relevant document.
- Enter all analytical record concurrently when analysis is being carried out.
- Ensure all the laboratory documents are securely placed in polythene folder and kept at the designated place.
- All analytical work shall be carried out by referring to approved current document such as SOPs, GTPs
- Protect all documents from spillage of chemical and solution when performing analysis.
- Circle the desire option, when multiple options are provided unless specified otherwise.
- Use only class “A” category volumetric glassware (Pipettes, burettes and volumetric flask).
- Store all cleaned and dried glassware in dust free storage area.
- Use clean and dry glassware for analysis.
- Check glassware for any cracks or dirt before using them.
- Glassware meant for residual solvent analysis, can be dried at a higher temperature to avoid any trace contamination.
- To the extent possible rinse the glassware with solvent or diluent which is meant for analysis in case of critical test procedure such as related substance.