Good Laboratory Practices (GLP)

History of GLP:

Good Laboratory Practices (GLP) was first introduced in New Zealand and Denmark in year 1972, and after it in the US in 1978 in response to the Industrial Bio Test Labs scandal.

The Organization for Economic Co-operation and Development (OECD) Principles of GLP were published a few years later in 1992, and the OECD has since assisted in the spread of GLP to many countries.

US- FDA has rules for GLP in 21CFR58.

What is GLP?

Good Laboratory Practices (GLP) is a quality system concerned with the organizational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported.

GLP principles include

Organization and Personnel
1. Management-Responsibilities
1. Sponsor-Responsibilities
1. Study Director-Responsibilities
1. Principal Investigator-Responsibilities
1. Study Personnel-Responsibilities
Quality assurance program
1. Quality Assurance Personnel
Facilities
1. Test System Facilities
1. Facilities for Test and Reference Items
Equipment, reagents and materials
Test systems
1. Physical/Chemical
1. Biological
Test and reference items
Standard operating procedures
Performance of study
1. Study Plan
1. Conduct of Study
Reporting of results
Archival – Storage of Records and Reports

SOP on Good Laboratory Practices (GLP):

GLP in Laboratory:

It is essential that Analytical laboratory should meet the requirements as per established good lab practices (GLP) requirements. The laboratory should be well designed, equipped with qualified trained personnel, calibrated instruments, certified chemicals and standards, and established procedure for all activities going on in the laboratory.
Analytical laboratory should be kept clean and the workbenches should be kept tidy and free from crevices. Cleaning of laboratory should be strictly followed.
The laboratory should have sufficient lighting, air ventilation to facilitate ease of work.
Chemical and instrument laboratories should be separated from each other. Separate rooms should be provided for sensitive instruments which is free from vibration, electrical interference, humidity, etc.
All chemical containers should have a legible, firmly attached label showing the contents of the container.
Clean and dry glassware/vessels should be used for handling of materials and it should be ensured that no contamination of material is observed.
Fire extinguishers should be provided to handle accidental situations.
Use of hoods should be made when using material or chemical which is likely to give off toxic or unpleasant odors or smoke.

Instruments/Equipments according to GLP:

All instruments/equipment should have a unique identification number and list of instruments/equipment should be maintained.
For every new major instrument, validation (IQ/OQ/PQ) should be carried out and documents for it should be maintained.
Written operating procedures (SOPs) should be displayed or at least be readily available for each instrument/equipment and should be followed every time it is used.
Instruments/equipment should be calibrated regularly at specified time intervals as per respective SOP.
Readily available records should be maintained for each instrument or a part of the instrument and indicate when the next calibration or service is due. The calibration date and next calibration due date should be displayed on the equipment/instrument itself.
Instruments/equipment calibration/ preventive maintenance schedules should be maintained if any. Instrument history cards depicting the instrument calibration/servicing /repairing should be maintained.
Analysts handling the instrument should be trained to use these effectively and accurately. It should be ensured before use that the equipment is working satisfactorily and its calibration status is valid.
When the instrument is in working condition, the status of the instrument/ equipment should be displayed with a status tag.
Logbooks of critical instruments should be maintained. Analysts operating the instruments should duly fill-up the logbook after usage of the instrument.
Defective and under breakdown instruments/equipment should be withdrawn from use until the fault is rectified. A warning label should be placed on the instrument/equipment indicating its status.
After rectification, the instrument should be calibrated to the extent required. It should be ensured before use that the instrument is working satisfactorily and its calibration status is valid.

Personnel in laboratory according to GLP

Personnel should adhere to the gowning procedure. All personnel engaged in the analysis should wear an apron (lab coat) in the laboratory and also safety glasses and hand gloves whenever required.
Analysts should work at a designated workplace and should keep their workplace neat and clean.
All analysts shall be qualified as per the written procedure. Proper training should be given to analysts for the operation of instruments, calibrations and analytical methodology.
Record of the qualifications, training, experience and job description for each personnel should be maintained individually.
Personnel should clearly understand the functions they should perform. Internal/ External training should be imparted to analysts regularly.
Unhygienic conditions/ practices should not be permitted eg. Eating, chewing, smoking, etc.
Temperature and humidity control
Proper temperature and humidity controls should be installed to maintain the temperature of the Analytical Laboratory at 25 ± 5°C.
Records must be maintained for temperature and humidity (for reference only) of the Instrument Lab and Chemical Lab.

Chemicals, glassware, reagents, and columns as Good Laboratory Practices (GLP):

Receipt, storage, issuance, discard of all the chemicals, solvents, and columns for HPLC/GC to be used in the laboratory should be documented as per respective SOP’s.
Hazardous chemicals should be handled with proper precaution and should be stored separately. MSDS of the hazardous chemicals should be made available with the chemicals. Volatile / Flammable solvents should not be stored in the vicinity of open flame, or hot plates.
At the time of opening the reagent/chemical bottles, the date of the opening must be put on the bottle.
All the reagents and chemicals should be capped properly to avoid any spillage.
While pipetting of the solvents/acids and hazardous chemicals suction bulbs must be used. The analyst must wear safety goggles, a mask, hand gloves, and a protective lab coat before dispensing such materials.
Appropriate “Class A” glassware should only be used for quantitative measurements. Glassware must be cleaned as per the established SOP. All the glassware under use should be properly labeled.
Used glassware should be cleared from the workbenches after analysis and should be emptied, and rinsed with tap water. They should be sent for washing after evaluation of results.
Preparation of reagent solution and volumetric solutions should be recorded in the LNB. (If these solutions are required to be stored for a certain period, then LNB number and the page number should be mentioned on the container label.)
HPLC/GC column usage should be recorded in logbooks after usage & column washing by the analysts after analysis is conducted.
Purified water in the wash bottles should be changed every day. The wash bottles should be labeled.

Working standards and Reference standards as per GLP

Working standards and Reference standards should be handled as described in the SOP – ‘Preparation and Handling of Laboratory Standards’
Sample Management and Documentation
Samples received for testing should be received, stored, analyzed, and discarded as per established procedures.
Sample under analysis shall be put in a designated container named ‘SAMPLES FOR ANALYSIS’. Analyzed samples shall be put in a container labeled as ‘ANALYZED SAMPLE’.
Samples should be tested in accordance with the test methods detailed in the relevant method of analysis/references. The results obtained shall be checked as necessary against the specification, if any before the material is released or rejected.
Check the use before / expiry date before using any reagents/chemicals / standards. Calibration status should be checked before using any instrument.
All data generated during analysis should be fully documented and recorded in the appropriate workbook.
Identification number of Instruments/Column/Standards should be recorded in the workbook. Weight prints/calculation sheet should be supported by pasting weight printout followed by cross signature with date. For calculation of the various data validated Excel sheet/Calculator should be used.
All the documents should be written/filled clearly and in case of error, corrections should be made as described in SOP – ‘Good Documentation Practices (GDP)’
Sign and date the final report to indicate acceptance of responsibility for the validity of the data.
All the records should be securely stored to protect content for untimely deterioration and facilitate easy retrieval.
Archive facilities should be used for the secure storage and retrieval of study plans, raw data, final reports, and samples of test items.

Safety Precaution as per GLP

These are the only guidelines; it serves as a reminder of things to work safely.
Each laboratory employee shall be familiar with the location and use of the following safety devices:
- First aid kit
- Eye wash bottle
- Fume hood
- Fire extinguisher
- Safety goggles

Pour more concentrated solutions into less concentrated solutions to avoid violent reactions. Use fume hoods for fuming chemicals ensuring that open flames and heat are closed.
While opening shield bottle of liquid chemical maintain the safe distance.
Never use your mouth to pipette chemicals. Never taste or smell chemicals (solid/liquids) in lab. Wash hands before leaving laboratory.
Never eat and drink any eatables in the laboratory. It should always be in the designated place i.e. tea/coffee room.
Clean up all small spills immediately. If a large chemicals spill occurs that you are unable to clean-up call housekeeping worker for proper cleaning.
If volatile, flammable, or toxic materials spill, shut off flames and spark-producing equipment immediately.
Segregate and prepare chemical wastes for collection in accordance with the standard procedures. Deposit all waste in designated containers.
The personnel working in the laboratory should be trained for the operation of Fire Extinguisher.
The training on periodic basis should be imparted regularly and training record should be maintained.
The performance of safety measures (such as Fire extinguishers etc) shall be verified for its proper functioning on periodic basis and their status shall be depicted using tag or label.

Read More:

Documentation Practice (GDP) & ALCOA++

Acronyms and Abbreviations of Letter F-J (F, G, H, I, J)

Alcohol Dose Dumping

Calibration of Disintegration Apparatus (DT)

Difference between Suspension and Emulsion

Reference:

Code of Federal Regulations Title 21 (Food and Drugs) Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies) (USA)

https://en.wikipedia.org/wiki/Good_laboratory_practice#cite_note-6

Good Laboratory Practice

“Good laboratory practice (GLP) for safety tests on chemicals”

Have a Question? : Click Here