QA QC Flashcards

1
Q

Planned activities designed to provide a quality product.

A

Quality Control

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2
Q

Program designed to make the measurement process as reliable as possible.

A

Quality Assurance

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3
Q

Procedures are activities designed to identify and determine sources of error.

A

Quality Control

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4
Q

Planned activities designed to ensure that the quality control activities are being properly implemented.

A

Quality Assurance

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5
Q

Means of ensuring
that the method remains in ‘control’ -
continues to perform in accordance with expectations.

A

Control Chart

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6
Q

Quality system concerned with the organizational process and the conditions under which a study is
planned, performed, monitored, recorded, archived, and reported.

A

Good Laboratory Practice

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7
Q

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.

A
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8
Q

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.

A
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9
Q

A substance that are inserted into the run alongside the test materials and subjected to the same treatment.

A
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10
Q

A program designed to make the measurement process as reliable as possible.

A
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11
Q

An activity designed to identify and determine sources of error.

A
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12
Q

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.

A
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13
Q

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.

A
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14
Q

It refers to procedures undertaken by laboratory for continuous monitoring of operations and measurement results.

A
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15
Q

To determine contamination of equipment and assess the efficiency or equipment clean-up procedures.

A
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16
Q

To detect contamination from reagents, sample handling, and the entire analytical process.

A
17
Q

Analysis of reference materials or samples of know concentration.

A
18
Q

Analysis of matrix spikes

A
19
Q

Analysis of blanks

A
20
Q

To measure the amount of the analytical signal which arises from the dilution solvent.

A
21
Q

A single sample split in the laboratory and measure laboratory precision based on relative percent difference between the sample and SD.

A