25 Questions
What is the primary purpose of quality assurance in a laboratory?
To ensure ongoing customer confidence in laboratory work
What is the standard that focuses on laboratory accreditation?
ISO 17025
What does GLP stand for in the context of quality assurance?
Good Laboratory Practice
What is the focus of QA standards in a laboratory?
To ensure the quality of analytical data
What is the purpose of introducing QA standards in a laboratory?
To ensure ongoing customer confidence in laboratory work
What is the purpose of Good Laboratory Practice (GLP)?
Making risk or safety assessments
What is an example of when Good Laboratory Practice (GLP) is used?
During risk or safety assessments
What is Good Laboratory Practice (GLP) an example of?
A quality control process
In what field is Good Laboratory Practice (GLP) commonly used?
Chemicals
What is Good Laboratory Practice (GLP)?
A quality assurance scheme for safety testing of chemicals
What types of chemicals are covered under Good Laboratory Practice (GLP)?
Pharmaceuticals, agrochemicals, cosmetics, food and feed additives, and biocides
What is the primary focus of Good Laboratory Practice (GLP)?
Enhancing data quality
What is the primary goal of Good Laboratory Practice (GLP)?
To ensure the quality and reliability of safety testing results
What is the outcome of Good Laboratory Practice (GLP)?
Results that can be relied upon
What is the focus of Good Laboratory Practice (GLP) in terms of testing?
Safety testing of chemicals
Why is it crucial to ensure traceability of the sample and its analytical results?
To prevent assigning the wrong result to a patient
What is the primary goal of traceability in laboratory testing?
To relate the sample and its results to the originating patient
What is the main purpose of GLP?
To provide a framework for laboratory studies
What is included in the GLP framework?
Planning, performing, monitoring, recording, reported, and archived
What could be the consequence of assigning the wrong result to a patient?
A fatal outcome
What is the primary focus of GLP?
Laboratory studies
Why is it important to maintain the integrity of the sample and its analytical results?
To relate the sample and its results to the originating patient
What is the key benefit of ensuring traceability in laboratory testing?
Enhanced patient safety
What is the ultimate goal of GLP?
To ensure quality and consistency of laboratory studies
What is NOT part of the GLP framework?
Maintaining laboratory equipment
Study Notes
Introduction to QA
- Ensuring the quality of analytical data in the laboratory is essential to maintain ongoing customer confidence.
- QA is crucial to prevent fatal consequences of assigning wrong results to patients.
QA Standards
- ISO 9001
- ISO 17025
- ISO 15189
- GLP (Good Laboratory Practice)
- GMP (Good Manufacturing Practice)
- Laboratory accreditation is essential for QA.
Good Laboratory Practice (GLP)
- A QA scheme for ensuring safety testing of chemicals, including:
- Pharmaceuticals
- Agrochemicals
- Cosmetics
- Food and feed additives
- Contaminants
- Novel foods
- Biocides
- Provides a framework for planning, performing, monitoring, recording, reporting, and archiving laboratory studies.
- Ensures reliable results, particularly for risk or safety assessments.
This quiz covers the introduction to quality assurance, QA standards, and laboratory accreditation. It includes ISO 9001, ISO 17025, ISO 15189, GLP, GMP and other standards.
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