Good laboratory practices

1. GOOD LABORATORY PRACTICES
Presented by;
Mr. Olado Simon Peter
BSc. Technology Chemistry
Department Of Chemistry
Faculty of Science
Kyambogo University
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2. INTRODUCTION
• Good Laboratory Practice(GLP) is a quality system concerned with the
organizational process and the conditions under which non-clinical health and
environmental safety studies are planned , performed, monitored, recorded,
archived and reported.
• It is a quality system which intends to ensure through careful and accurate
documentation , covering all aspects of study and of its environment, the
quality , integrity and reliability of safety data.
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3. INTRODUCTION
Examples of laboratories that require GLPs
Pharmaceutical QCA for human drugs, animals (vet) and pesticides
Cosmetic QCA
Food and beverages QCA
Feed additives QCA
Industrial chemicals QCA
Research labs
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4. Purpose of GLP principles
To promote the development of quality test data
Obtain reliable and reproducible data
Obtain comparable data between countries
Achieve international confidence in study data (ISO influence)
Avoid repetition of studies
Enable reconstruction of studies
Optimize animal conditions
Shorten the registration time of the drug
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5. Responsibility of GLPs
Cleaning staff aka laboratory attendants
Laboratory technicians
Analysts
Laboratory managers
Organization management
To some extent: visitors and regulatory bodies
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6. Responsibilities: Cleaning staff
Must have proper qualifications.
Ensuring that the lab is always maintained clean
Request materials for cleaning
Ensure equipment are stored in their right place.
Monitor consumption of materials.
Ensure organization in the laboratory
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7. Responsibilities: technicians and analysts
Ensure proper acceptable laboratory design and layout.
Ensure that lab attendants do their work.
Ensure right methods; SOPs are used in the analysis
Carry out stock taking and make timely reports.
Ensure right chemicals are procured and right time and used accordingly
Maintain equipment especially in preventative and trouble shooting maintenance.
Make reports following laboratory ethics and test results
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8. Responsibilities: Laboratory managers
Ensure that qualified personnel are recruited into the laboratory.
Ensure the lab staff follow GLPs
Represent the laboratory to the top management
Carry out planned and unplanned training of the staff.
Present the GLPs requirements to the top management
Make sure the personnel are protected while at their work through use of PPEs.
Ensure limited involvement of manual labour in analysis.
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9. Responsibilities: top management
Comply with GLP requirements
Provide necessary support through release of finances required to ensure GLPs.
Responsibilities of visitors
Note: labs must have restricted access hence visitors both trained and non trained must not have free
access to lab space. Where inevitable, their access must be highly supervised by a technical personnel.
Responsibility of regulatory bodies
Ensure that the practices are implemented
Ensure planned and unplanned audits are carried out.
Provide necessary documentations like SOPs for credible analysis.
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10. Personnel
• The personnel must be of good health
• appropriate qualification to do allocated work
• Proper training must be undertaken
• Follow SOPs in all their work
• At all times, be in PPEs
• All personnel that get access to the lab must take registration
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11. Laboratory space
Laboratory space
• Must of a proper design with a proper layout
• Must allow free mobility of personnel
• Ensure proper storage of chemicals
• Back up plans should be installed for example standby generator.
• There should be space for storing released materials and lab consumables.
• The lab must not be located in a highly risky place. For example the space that is
free from fire risks
• Work surface must be designed to withstand chemicals
• Food and the like materials are banned in the laboratory.
• Proper water supply system and drainage must be installed.
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12. Chemicals storage
 Proper reception of chemicals and equipment must be put in place with
document.
 Quarantined materials must not be stored together with other materials.
 Acceptance criteria must be established
 Methods of verification must be established unless there are audits on the
supplier.
 Chemicals must stored properly. Sometimes external stores are necessary.
 There must be a good organization in the store
 Only released chemicals should be used.
 Stores present a high level of risk, so there should be established methods to
lower the risk.
 Only authorized personnel should access stores.
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13. Test methods
• All test methods must be documented
• The methods must be standard and acceptable to results reach.
• All experiments must be carried out following documented procedure
irrespective of the expertise.
Reporting results
 Results must be reported as obtained from test equipment or procedure.
 Results reported must be based on multiple trials.
 Timely reports; Duplicate reports must be stored for reference
 Results must not be shared with unauthorized personnel or institutions.
 All results must be countersigned by analyst or lab manager
 There must be measures in place to prevent forging of results through issue of
certificate of analysis with security features.
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14. Reporting results
 Results must be reported as obtained from test equipment or procedure.
 Results reported must be based on multiple trials.
 Timely reports; Duplicate reports must be stored for reference
 Results must not be shared with unauthorized personnel or institutions.
 All results must be countersigned by analyst or lab manager
 There must be measures in place to prevent forging of results through issue of
certificate of analysis with security features.
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15. Equipment
• Every equipment should have documents that aid in their operation, maintenance
and troubleshooting.
• Equipment should be maintained in good working condition at all times.
• Its necessary to keep equipment at work. Redundant equipment rot or corrode.
• There should planned and unplanned maintenance
• Quarantined equipment should not be used.
• Regular calibration of equipment with a set acceptance criteria
• Procure from compliant suppliers
• Only trained personnel should be allowed to operate equipment.
• Only released equipment should be used.
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16. Disposal
This must be done by authorized personnel.
Environmental implications must be considered.
Disposal should follow approval and ascertained that the materials to be
disposed are worth disposal.
Sorting before disposal is a good practice
The disposal site should taken as HW dumping site.
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17. Audits and Training
• Audits
This necessary in improve lab performance and capacity building.
Equipment, personnel and chemicals need to be audited and documented.
• Training
Necessary to improve the skills hence performance of staff.
Refresher training
All new staff must be trained first be entrusted with shifts.
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18. Thank you
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