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
Double-checking bottle labels before starting each test.
Quality assurance
Regularly evaluating standard procedures carried out by lab techs
and interns.
Quality assurance
Sterilizing equipment and preventing personal contamination
through the distribution of gloves, hairnets, and lab coats.
Quality assurance
Regularly calibrating equipment and machines.
Quality assurance
Having a system in place where each data entry gets approved by
two sets of eyes.
Quality control
planned activities designed to provide a quality product.
Quality Control
planned activities designed to ensure that the quality control activities are being properly
implemented.
Quality Assurance
Quality Assurance Sytems include
- identifying the person having the overall responsibility for quality
- having laboratory equipment calibrated to recognised standards
- using reference materials
- joining proficiency testing schemes with other laboratories doing similar tests
Quality Control Sytems include
- reagent blanks
- verified standard solutions
- check samples (from both within and outside the lab)
- blind samples
- replicate analyses
- control charts
a means of ensuring
that the method remains in ‘control’ - continues to perform in accordance with expectations.
Control chart
In an absolute sense, the ‘true’ value can be defined only as being
that value directly traceable to the base system of measurement (SI) or
their derivatives via an unbroken chain of comparisons
Measurement traceability
are prepared and quantity values of
target components are checked against CRMs
Internal Quality Control
An accredited laboratory has to prove its performance by routinely analysing samples supplied by an independent laboratory
Proficiency testing
defines the quality system under which the laboratory operates
Quality manual
The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs “(ISO).
Quality
Assembly and management of all activities aimed at the production of quality.
Quality Management
All those planned and systematic actions necessary to provide adequate confidence that a product, process or service will satisfy given requirements for quality (ISO 9000).
Quality Assurance
Are ideal control materials in that they can be regarded for traceability purposes as ultimate standards of trueness.
Certified Reference Materials (CRM)
It is a quality system concerned with the organizational process and the conditions under which a study is planned, performed, monitored, recorded, archived, and reported.
Good Laboratory Practice
The operational techniques and activities that are used to fulfill
requirements for quality (ISO 9000)
Quality Control
contains additional information on proficiency tests and proficiency testing providers.
ISO/IEC 17043
