Font size
WorksheetsGood Laboratory Practises_18601917108
Total questions: 15
Worksheet time: 8mins
In early 70's in USA, FDA had decided to check over____________ toxicology labs in depth.
40
41
39
38
Good Laboratory Practices is an official regulation that was created by the FDA in which year?
1977
1978
1975
1976
The GLP regulations that are accepted as international standards for non-clinical laboratory studies published by the US Food and Drug Administration in (a) supplied the basis for the work of the Expert Group of FDA.
what is the full form of OECD?
Organization for Economic Co-operation and Development
Organization for Eminent Co-operation and Development
Organization for Economic Co-operation Department
Organization for Economic Corporate Department
The Environmental Health and Safety Division publishes free-off charge documents in-
Testing and Assessment
Principles on Good Laboratory Practice and Compliance Monitoring
Pesticides and Risk Management
Chemical Accidents and Harmonization of Regulatory Oversight in Biotechnology
the Principles of Good Laboratory Practice (GLP) have been developed to promote the quality and validity of test data used for determining the safety of chemicals
and chemical products.
true
false
A quality system related with the organizational process and the conditions under which non-clinical health and
environmental safety studies are planned, performed, monitored, recorded, archived and reported is known as-
(a)
what are the following principles of Good Laboratory Practices?
to support the development of quality and validity of test data used for determining the safety of chemicals and chemicals
product
to decrease the occurrence of mistakes or mix-ups through large and specific labeling requirements.
to place a high degree of reliance upon creating and following a per-defined study plan.
all of the above
GLP includes which of the following points?
Test facility management
Quality assurance programme
Meeting the requirements of the test facility
Receipt, handling, sampling and storage
(a) means the persons, premises and operational units that are necessary for conducting the non-clinical health and environmental safety study.
which of the following requirement of Test Facility?
should be of appropriate size, construction and location to meet the requirements of the study.
should be designed safe enough to get the validation results
confidently.
The GLP Principles are designed to avoid the factors that would endanger the reconstructability of a study, by giving the only and final responsibility for the GLP
compliant conduct of a study to one single person, the Study Director. For each nonclinical laboratory study, a scientist or other professional of appropriate education, training, and experience should be identified as the study director.
true
false
The (a) has to be aware of all possible circumstances that might affect the quality and integrity of a study.
The GLP Compliance Statement signed by the Study Director in the final study report.
false
true
(a) is the process, procedures and authority used to accept or reject all components, drug product containers, closures, in-process materials, packaging material, labeling and drug products and the authority to review production records to assure that no errors have occurred, that they have been fully investigated. The quality and reliability of test data count on the state and condition of the test system which is used in its production.
