Related Experiment Video
Updated: Apr 16, 2026
![Technical Aspect of the Automated Synthesis and Real-Time Kinetic Evaluation of [11C]SNAP-7941](/_next/image?url=https%3A%2F%2Fcloudfront.jove.com%2FCDNSource%2Fteasers%2F59557.jpg&w=3840&q=50)
09:50
Technical Aspect of the Automated Synthesis and Real-Time Kinetic Evaluation of [11C]SNAP-7941
Published on: April 28, 2019
8.1K
Performance criteria and quality indicators for the pre-analytical phase
Clinical Chemistry and Laboratory Medicine
|February 27, 2015
Summary
Establishing quality indicators (QIs) for the total testing process (TTP) is crucial. Harmonized QIs help detect pre-analytical errors, improving laboratory quality and reducing analytical mistakes.
Area of Science:
- Clinical Laboratory Science
- Quality Management in Healthcare
Background:
- Analytical quality specifications are vital for laboratory service quality and error reduction.
- Growing evidence highlights the impact of pre-analytical phases on overall laboratory data quality.
Purpose of the Study:
- To identify and establish valuable quality indicators (QIs) for the total testing process (TTP).
- To detect errors in the pre-analytical phase and inform quality improvement initiatives.
Main Methods:
- Developing a harmonized list of QIs through consensus.
- Collecting performance data from clinical laboratories worldwide for available QIs.
Main Results:
- Harmonized QIs provide a basis for setting performance targets.
- Collected data allowed classification of QI performances into optimum, desirable, and minimum levels.
Conclusions:
- Harmonized QIs are essential for monitoring and improving the quality of the total testing process.
- Classifying QI performance aids in achieving realistic quality specifications in clinical laboratories.
Related Concept Videos
01:29Clinically Relevant Drug Product Specifications: Methods of Establishment
285
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
285
01:19Quality Assurance
4.0K
Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
4.0K
01:28Preclinical Development: Overview
6.5K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
6.5K
01:21Development of Analytical Methods
3.2K
An analytical methodology can be divided into four sequential steps: technique, method, procedure, and protocol. A technique is a scientific principle that rationalizes a specific phenomenon through chemical measurements. Adapting a technique for analyzing a sample of interest is termed a method. The procedure outlines the directions for performing the analysis via an analytical method. The protocol is the detailed guidelines on the procedure, which should be strictly followed to obtain the...
3.2K
01:15Data Validation
3.6K
Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
Key parameters for method validation include:
Key parameters for method validation include:
3.6K
01:05Quality Control
4.3K
Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
Quality control helps track data, visualize trends, and identify variations, making it easier to detect deviations that may affect the accuracy of an analysis. One way to do this is by generating a quality control chart, which...
Quality control helps track data, visualize trends, and identify variations, making it easier to detect deviations that may affect the accuracy of an analysis. One way to do this is by generating a quality control chart, which...
4.3K