The Principles of Good Laboratory Practices (GLP)

1. Test facility, organization and personnel

  • Test facility management’sresponsibilities
  • Study director’sresponsibilities
  • Principal investigator’sresponsibilities
  • Study personnel’sresponsibilities

2. Quality Assurance (QA) program

  • 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
  • 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 (SOP’s)

  • 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) 
– Record keeping, reporting, storage and retrieval 
– Coding system, data collection, preparation of reports, indexing system, handling of data 
– Room preparation, environmental room conditions, receipt, transfer, identification etc, test system preparation, observations etc,

  • Quality Assurance Procedures

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

  •  Conduct of the study

– Identification of each study

– The study to be conducted in accordance with the study plan

– Data generated to be recorded directly and accurately

– Changes in the raw data not to obscure the previous data

– Identification of electronic data


9. Reporting of study results

  • 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, Evaluation discussion and conclusions) 

– Storage (of samples, reference items, raw data, final reports etc.


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)

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