Good Laboratory Practices (GLPs) and Good Housekeeping Practices (GHPs)

 

 

GOOD LABORATORY PRACTICES

GLP is a formal regulation that was created by the FDA (United states food and drug administration) in 1978.

GLP embodies a set of principles that provides a frame work within which laboratory studies are planned performed, monitored, and archived and reported.

 

Reasons for developing GLPs:

 • Poor laboratory practices such as i) equipment not been calibrated to standard form , therefore giving wrong measurements ii) Incorrect/inaccurate accounts of the actual lab study iii) Inadequate test systems.

 

Purpose of GLPs:

Ensure that every step of the analysis is valid or Not.

Assure the quality & integrity of data.

GLPs have heavy emphasis on data recording, record & specimen retention.

 

GLP Practices and principles

 

1.      Test Facility Organization and Personnel.

The study personnel should demonstrate knowledge on the following GLP principles:

ü  Access to the study plan and appropriate SOP’s

ü  Comply with the instructions of the SOP’s.

ü  Record raw data

ü  Study personnel are responsible for the quality of their data

ü  Exercise health precautions to minimize risk.

ü  Ensure the integrity of the study.

 

2.      Quality Assurance Programme (QAP)

A quality assurance program ensures access to the updated study plans and SOP’s, documented verification of the compliance of study plan to the GLP principles and inspections to determine compliance of the study with GLP principles.

 

Three types of inspection: Study-based inspections, facility-based inspections and process-based inspections. Inspection of the final reports for accurate and full description, report the inspection results to the management and statements.

 

 

3.      Facilities.

ü  Suitable size, construction and location

ü  Adequate degree of separation of the different activities

ü  Isolation of test systems and individual projects to protect from biological hazards

ü  Suitable rooms for the diagnosis, treatment and control of diseases

ü  Storage rooms

 

 

4.      Apparatus, Material and Reagents.

 

ü  Apparatus of appropriate design and adequate capacity

ü  Documented Inspection, cleaning, maintenance and calibration of apparatus

ü  Apparatus and materials not to interfere with the test systems

ü  Chemicals, reagent and solutions should be labeled to indicate identity, expiry and specific storage instructions

 

5.      Test systems

ü  Physical and chemical test systems

ü  Biological test systems

ü  Records of source, date of arrival, and arrival conditions of test systems

ü  Proper identification of test systems in their container or when removed

ü  Cleaning and sanitization of containers

ü  Pest control agents to be documented.

 

 

6.      Test and Reference Substances.

 

Test and Reference items are: Receipt, handling, sampling and storage • Characterization. • Known stability of test and reference items. • Stability of the test item in its vehicle (container). • Experiments to determine stability in tank mixers used in the field studies. • Samples for analytical purposes for each batch

 

 

7.      Standard Operating Procedures (SOP)

 

Standard Operating Procedures (SOP): Written procedures for a laboratories program. They define how to carry out protocol- specified activities. It is written in a chronological listing of action steps. They are written to explain how the procedures are supposed to work.

 

8.      Performance of the Study.

Prepare the Study plan

• Content of the study plan: Identification of the study › Records › Dates › Reference to test methods › Information concerning the sponsor and facility.

 • Conduct the study

 

9.      Reporting of Study Results.

• Information on sponsor and test facility. • Experimental starting and completion dates. • A Quality Assurance Program Statement. • Description of materials and test methods. • Results. • Storage (samples, reference items, raw data, final reports) etc.

 

 

 

 

 

 

10. Storage and Retention of Records and materials.

 

The study plan, raw data, samples. – Inspection data and master schedules. – SOPs. – Maintenance and calibration data. – If any study material is disposed of before expiry the reason to be justified and documented. – Index of materials retained.

 

 

 

Characteristics of a good laboratory

ü  Area should be free from smoke, smell, dust etc.

ü  Ensure good ventilation, proper illumination and prefer natural light.

ü  Air conditioned the lab with humidity control.

ü  Enough space for measuring and testing instrument.

ü  Proper arrangement of testing.

ü  Take care of all safety points including proper earthing as well as fire safety.

ü  Avoid un-cleanable spots in floors, walls, ceiling.

ü  Establish proper areas for storage of incoming samples as well as test–completed samples.

ü  Also provide sample collection place as well as packing and disposal of tested samples.

 

 

Examples of good laboratory practices:

ü  Keep the things at its location after use.

ü  Store heavy things at bottom & if possible on Trollies. • Give name of location to everything.

ü  Follow “Everything has the place & Everything at its place” principle.

ü  Prepare location list & display it.

ü  Put ladders for things stored on top.

ü  Identify everything with its name/ purpose.

ü  Follow “FIFO” to prevent old accumulation for laboratory chemicals.

 

Benefits of good laboratory practices

ü  It will give better image of company as a Quality producer in Global market.

ü  Provide hot tips on analysis of data as well as measure uncertainty and perfect record keeping.

ü  Provide guideline for doing testing and measurement in detail.

ü  Provide guidelines and better control for maintenance of instruments, environment control, preservation of test records etc

 

 

 

 

 

 

 

 

 

 

GOOD HOUSEKEEPING PRACTICES

General

• Keep containers and equipment away from the edge of benches: Organize bench tops with large equipment in the back and progressively smaller equipment toward the front. Leave sufficient space to perform your work safely and to avoid reaching over items that can easily be knocked over, such as graduated cylinders or flasks. Keep all containers and glassware at least two (2) inches away from the front of the lab bench.

• Promptly clean and properly store glassware: Avoid accumulating glassware on lab benches and in sinks. Promptly clean and store glassware in its designated/protected location at the end of an experiment or work session.

• Regularly check glassware for starring, cracks, and chips and promptly discard or repair damaged glassware: Dispose of glassware in accordance with the EHS SOP, Glass Disposal – Intact or Broken

• Discard disposable pipettes and pipette tips immediately after use: Take care not to clutter bench tops or the floor with discarded pipets or pipette tips.

• Provide physical separation of regular trash containers from bio-hazardous and radioactive material waste containers to avoid improper disposal of contaminated materials. Prominently label bio-hazardous and radioactive material waste disposal containers.

• Keep drawers and cabinets closed when not in use.

• Maintain clear access to utility controls and emergency equipment at all times.Remove any equipment or clutter that interferes with access to or visibility of eyewash stations, safety showers, fire alarm pull stations, fire alarm strobes, fire extinguishers, electrical panels, knife switches, equipment on/off controls, ventilation controls, etc.

Chemicals

• Keep bench-tops, scales, and other equipment clean; promptly clean up spill residues and other dirt and grease accumulations.

• Keep bulk chemicals stored in cabinets or designated storage rooms. Only obtain the amount needed for your current work session. Doing this keeps benches free of excess chemicals and reduces exposure in case of a spill or accident.

• Containers used for chemical storage must have lids/caps. Lids and caps reduce the possibility of a spill and potential release of fumes into the lab.

• Label all containers of chemicals/experimental intermediates and keep a current chemical inventory.

 

Aisles and Floors

• Keep aisles and passageways clear at all times. Aisles are the passageways to safety in the event of a fire or chemical release. They should be easy to navigate even when visibility is poor (e.g., smoke is in the laboratory). Obstructing aisles and passageways is a fire code violation and contributes to slips, trips, falls, and other accidents.

• Immediately clean up any spilled liquids or ice on floors. Liquids and frozen liquids (e.g., ice) on floors can lead to slips, trips, and falls. Leaking equipment (oil from vacuum pumps) can also be a slip hazard.

• Repair damage to and protrusions from the floor immediately. Damaged floor tiles and curled or worn mats represent trip hazards.

• Use appropriate trash and waste containers to prevent clutter and debris on floors.