Quality Assurance Flashcards
A periodic assessment of the performance of individual
laboratories and groups of laboratories that is achieved by the
distribution by an independent testing body of typical materials of
unsupervised analysis by the participants.
Proficiency testing
A group of samples which behave similarly with respect to the
sampling, or the testing procedures being employed, and which
are processed as a unit.
Batch
A substance that are inserted into the run alongside the test
materials and subjected to the same treatment.
Control materials
A program designed to make the measurement process as reliable
as possible.
Quality assurance
A system of processes and procedures that pharmaceutical and medical device manufacturers must adhere to in order to ensure
that their products are of the highest quality.
GMP
An activity designed to identify and determine sources of error.
Quality control
A quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of products in development for human or animal health (including pharmaceuticals) through non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests.
GLP
It refers to procedures undertaken by laboratory for continuous
monitoring of operations and measurement results.
Internal Quality Control
To detect contamination from reagents, sample handling, and the
entire analytical process.
Method blank
Analysis of blanks
Contamination
Analysis of reference materials or samples of know concentration.
Accuracy
Analysis of matrix spikes.
Extraction Efficiency
A single sample split in the laboratory and measure laboratory
precision based on relative percent difference between the sample
and SD.
Duplicate
To measure the amount of the analytical signal which arises from
the dilution solvent.
Calibration blank
Running both a duplicate sample and a blank sample to compare
test results.
Quality control
