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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