Trivia Quiz On Good Laboratory Practice Regulations

The correct answer is "All of the above" because records can be created through various processes such as planning documents (protocols and SOPs), doing documents, checking documents, and improvement documents. Each of these processes involves the creation of records as a result of different activities and actions. Therefore, all the given options are valid explanations for the creation of records.

GLP, which stands for Good Laboratory Practice, is an official regulation that was created by the FDA (Food and Drug Administration). The question asks for the year in which GLP was created, and the correct answer is 1978. This means that in 1978, the FDA established the GLP regulation to ensure the quality and integrity of non-clinical laboratory studies conducted for the submission of research data to support applications for research or marketing permits for FDA-regulated products.

GLPs stand for Good Laboratory Practices, which are a set of guidelines and regulations that ensure the quality and integrity of non-clinical laboratory studies. These practices include the proper documentation of procedures, personnel training, equipment calibration, and data management. GLPs are essential in maintaining accurate and reliable results in research and development, as well as in regulatory submissions for pharmaceuticals, chemicals, and other products. Therefore, GLPs can be considered a quality assurance system as they provide a framework for ensuring the quality and reliability of laboratory studies.

Quality at PBL in a regulated environment is defined objectively as meeting the specified requirements. This means that the products or services provided by PBL must adhere to the predetermined standards and criteria set by regulations. The subjective aspect of quality, which involves exceeding expectations, is not applicable in this context. Therefore, the correct answer is an objective definition that means meet requirements.

The correct answer is A&B Only. This is because 21CFR58 and 40CFR160 are both GLP regulations or requirements. 21CFR211, on the other hand, is not a GLP regulation or requirement.

A test article is distinguished from a control article by the fact that it is subjected to the test system and is received from the customer. This means that the test article is specifically chosen and provided by the customer for testing purposes. In contrast, a control article is typically used as a standard or reference for comparison with the specimens being tested.

Facility Management is most responsible for "Planning" in the Quality cycle. Facility Management involves the coordination and planning of various aspects related to the physical infrastructure, equipment, and resources of an organization. In the context of the Quality cycle, Facility Management would be responsible for planning and organizing the necessary facilities and resources required to ensure the quality of products or services. This includes planning for maintenance, calibration, and availability of equipment, as well as ensuring a suitable working environment for the employees.

The correct answer is "Items removed from an animal for further study by histopathology." This is because the question asks for something that is NOT a test system, and the other options listed (any animal, plant or microorganism, reagents and workspace around the experiment) can all be considered test systems in some way. However, items removed from an animal for further study by histopathology are not considered a test system themselves, but rather samples taken from a test system for analysis.

The Quality Assurance Unit (QAU) is responsible for ensuring that all aspects of a study are conducted in accordance with Good Laboratory Practice (GLP) regulations. This includes checking the work of the study director to ensure that they are following the approved protocol and conducting the study properly. Therefore, the statement "Checks the work of the study director" is correct as it accurately describes one of the responsibilities of the QAU in a GLP study.

The correct answer is "Is the single point of contact for study control." This means that the Study Director is responsible for coordinating and overseeing all aspects of a study, serving as the main point of contact for communication and control. They are responsible for ensuring that the study is conducted according to regulations and guidelines, managing resources, and ensuring the integrity of the study. This role involves coordinating with various stakeholders, including sponsors, investigators, and regulatory authorities.