Department of Biomedical Sciences
Laboratory Management IV
LBT418P
Lecture 1: Good Laboratory Practices (GLP)
Lecture Prepared by:Mr Brian Peba
Employer: Agricultural Research Institute Onderstepoort Veterinary Institute
Section: Epidemiology, Parasites and Vectors Program
Positions: Chief Research Technologist
Area of Responsibility: Quality Assurance and Serology Diagnostics Project manager
The birth of the GLP regulations
In the early 1970s, the conduct of non-clinical studies by some test facilities raised much concern in the USA.
This led to the publication of the GLP regulations by the USFDA in 1976, which in turn formed the basis for the
OECD (Organisation for Economic Co-operation and Development) principles of GLP established in 1978 under
the Special Programme on the Control of Chemicals.
Good Laboratory Practice (GLP)
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
▪ Reported
The Primary Aim
The driving force behind the GLP principles is the need for concerted action amongst OECD Member countries
to protect man and the environment from exposure to hazardous chemical
GLP - Purpose
▪ Promote development of quality test data
▪ Mutual acceptance of data among countries on the basis of comparable quality
▪ Avoid duplicative testing, thereby saving time and resources
▪ Avoid technical barriers to trade
▪ Improve protection of human health and environment
GLP - Scope Non-clinical safety testing of test item contained in
▪ Pharmaceutical Products
▪ Pesticide Products
▪ Cosmetic Products
▪ Veterinary Drugs
▪ Food and Feed Additives
▪ Industrial Chemicals
The test items can be
▪ Synthetic Chemicals
▪ Natural
▪ Biological Origin
▪ Living Organisms
The GLP Principles
1. Test facility organization and personnel
2. Quality Assurance (QA) program
3. Facilities
4. Apparatus materials and reagents
5. Test systems
6. Test and reference items
7. Standard Operating Procedures (SOP’s)
8. Performance of the study
9. Reporting of study results
10. Storage and retention of records and materials
1. Test Facility Organization and Personnel
▪ Test facility management’s responsibilities
▪ Study director’s responsibilities
▪ Principal investigator’s responsibilities
▪ Study personnel’s responsibilities
2. Quality Assurance Program
Responsibilities of the QA Personnel
▪ Designated individuals as members of the QA team directly responsible to the
management
▪ QA members not to be involved in the conduct of the study being assured
▪ Access to the updated study plans and SOP’s
▪ Documented verification of the compliance of study plan to the GLP principals
Inspections to determine compliance of the study with GLP principles
Three types of inspection
– Study-based inspections
– Facility-based inspections
– Process-based inspections
3. Facilities
▪ Suitable size, construction and location
▪ Adequate degree of separation of the different activities
▪ Isolation of test systems and individual projects to protect from biological hazards
▪ Suitable rooms for the diagnosis, treatment and control of diseases
▪ Storage rooms for supplies and equipment
▪ Separate areas for receipts and storage of the test and reference items
▪ Separation of test items from test systems
▪ Archive facilities for easy retrieval of study plans, raw data, final reports, samples of test items
and specimen
▪ Handling and disposal of waste in such a way not to jeopardize the integrity of the study
4. Apparatus, Materials and Reagents
▪ Apparatus of appropriate design and adequate capacity
▪ Documented inspection, cleaning, maintenance and calibration of
apparatus
▪ Calibration to be traceable to national or international standards
▪ Apparatus and materials not to interfere with the test systems
▪ Chemicals, reagent and solutions should be labeled to indicate
identity, expiry and specific storage instructions
5. Test Systems
▪ Physical and chemical test systems
– Appropriate design and adequate capacity of apparatus used for the generation of data
– Integrity of physical/chemical test systems
▪ Biological test systems
– Proper conditions for storage, housing, handling and care
– Isolation of newly received animal and plant test systems until health status is evaluated
– Humanely destruction of inappropriate test systems
▪ Records of source, date of arrival, and arrival conditions of test systems
▪ Acclimatization of biological systems to the test environment
▪ Proper identification of test systems in their housing or container or when removed
▪ Cleaning and sanitization of housings or containers
▪ Pest control agents to be documented
▪ Avoid interference from past usage of pesticides
6. Test and Reference Items
▪ Receipt, handling, sampling and storage
– Records for date of receipt, expiry date, quantities received and used in studies etc
– Handling, sampling and storage procedures to ensure homogeneity and stability and avoid contamination or mix-up
– Identification information on storage containers
▪ Characterization
– Identification of each test and reference item
▪ Code, CAS number, name etc
– Identification of each batch of the test or reference items
▪ Batch number, purity, composition, concentration etc
– Cooperation between the sponsor and the test facility
▪ Verification of identity of the test item
▪ 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
▪ Approved SOP’s to ensure the quality and integrity of the laboratory data
▪ Immediately available current SOP’s relevant to the activities being performed
▪ Deviations from SOP’s to be acknowledged by the study director
▪ SOP’s for
– Test and reference items
▪ Receipt, identification, labeling, handling, sampling, storage
– Apparatus
▪ Use, maintenance, cleaning, calibration – Computerized systems
▪ Validation, operation, maintenance security, change control, back-up
– Materials, reagents and solutions
▪ Preparation and labeling
7. Standard Operating Procedures
▪ Record keeping, reporting, storage and retrieval
– Coding system, data collection, preparation of reports, indexing system, handling of data
▪ Test system
– Room preparation, environmental room conditions, receipt, transfer, identification etc, test system
preparation, observations etc,
▪ Quality Assurance Procedures
– Operation of QA personnel
8. Performance of the Study
▪ Study plan
– Written plan, verified for GLP compliance, approved by the study director and by the management
– Approval of amendments by dated signatures
– Deviations to be explained and acknowledged
▪ Content of the study plan
– Identification of the study
▪ Title, nature and purpose of the study, test item identity, reference item used etc
– Information concerning the sponsor and facility
▪ Names and address (sponsor, test facility, study director)
– Dates
▪ Approval dates of the study plan, estimated starting and completion dates etc
– Reference to test methods
– Records
9. Reporting of Study Results
▪ General
▪ Final report for each study
▪ Scientists to sign and date their reports
▪ Approval by the Study Director
▪ Corrections, additions, amendments to be signed and dated by the study director
▪ Content of the final report
– Identification of the study
▪ Descriptive title, identification of the test and reference item, purity, stability
▪ Information on sponsor and test facility
– Name and addresses of the sponsor, test facility, study director, the scientists involved to the study etc)
• Experimental starting and completion dates
• A Quality Assurance Program Statement
• Description of materials and test methods
• Results – Including uncertainties, level of significance
10. Storage and Retention of Records and Materials
▪ What to retain in archives
– The study plan, raw data, samples
– Inspection data and master schedules
– Qualification, training experience, job description
– Maintenance and calibration data
– Validation data – SOPs
– Environmental, health & safety monitoring records
▪ Retention period to be defined
▪ If any study material is disposed of before expiry the reason to be justified and documented
▪ Index of materials retained in the archives
▪ Controlled access to the archives
▪ In case that the laboratory goes out of business the archives are transferred to the relevant sponsors(s)
Thank You!!!
