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PHARM ANA LEC > STATISTICAL QUALITY CONTROL > Flashcards

STATISTICAL QUALITY CONTROL Flashcards

1
Q

The MONITORING OF QUALITY by application of statistical methods in all stages of production.

A

STATISTICAL QUALITY CONTROL

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2
Q

refers to CHARACTERISTICS OF A PRODUCT from both a qualitative and quantitative point of view.

It refers to the QUALITY OF THE PROCESS as well as the PRODUCT ITSELF.

A

QUALITY

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3
Q

implies a PROCEDURE by which DECISIONS MAY BE MADE regarding whether production is proceeding according to plan and meeting established standards.

A

CONTROL

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4
Q

a COLLECTION OF DATA AND NUMBERS, and with the use of mathematics, can ANALYZE AND INTERPRET these DATA for the purpose of making meaningful decisions.

A

STATISTICS

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5
Q

a field of study concerned with:
1. The collection, organization and summarization of data.
2. The drawing of references about a body of data when only a part of the data is observed.

A

STATISTICS

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6
Q

Statistical methods involves

A

LONG PERIOD OF TIME

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7
Q

________ are so COMPLICATED that they cannot be understood or performed by ordinary production and inspection employees

A

METHODS

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8
Q

_______ monitoring by the production operator is conducted during a production run with MINIMUM SUPERVISION.

A

IN-PROCESS

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9
Q

_______ are USEFUL only when one is aware that A PROBLEM NEEDS CORRECTION.

A

TECHNIQUES

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10
Q

The use of _______ is stated in the standard operating procedures (SOP) as a MANDATORY ROUTINE TECHNIQUES as a visual tool that the process is in control.

A

SQC

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11
Q

The use of SQC is stated in the ___________________ as a mandatory routine techniques as a VISUAL TOOL that the PROCESS IS IN CONTROL.

A

STANDARD OPERATING PROCEDURES (SOP)

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12
Q

The effective use of the techniques of SQC is applicable only to how many department

A

ONE

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13
Q

how many basic Quality Control Charts are based on the MEASURABILITY OF THE QUALITY characteristics.

A

2

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14
Q

This is a chart which makes use of DISCRETE DATA classifying the number of items conforming and the number of items failing TO CONFORM TO ANY SPECIFIED REQUIREMENTS.

A

ATTRIBUTE CHART (P-chart / Fraction Defective Chart)

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15
Q

This a chart using actual records of NUMERICAL MEASUREMENTS on a full continuous scale such as meter, grams, or liter.

A

VARIABLE CHART (R-chart & 8)

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16
Q

Involves the AIM or OBJECTOF THE EXPERIMENT.

A

PLAN OF DESIGN OF THE EXPERIMENT

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17
Q

may be defined as the PROCESS OF REMOVING an appropriate no. of items from a bulk in order to make inferences (logical conclusions) to the entire bulk.

A

SAMPLING

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18
Q

The _________ must be EMPOWERED to sample at any point or stage of manufacturing and packaging operations.

A

QUALITY CONTROL INSPECTOR

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19
Q

The _________ must be EMPOWERED to sample at any point or stage of manufacturing and packaging operations.

A

QUALITY CONTROL INSPECTOR

20
Q

sampling plan formula

A

square root of N + 1

21
Q

known as MILITARY STANDARD – 105 D originated by a committee from military agencies of the USA, Great Britain and Canada.

A

GOVERNMENT SAMPLING PLAN

22
Q

The most COMMON AND DISTINCT methods of inspection / testing are based on _____

A

single or double sampling

23
Q

In _________, ONLY THE SPECIFIED SAMPLE SIZE is inspected and tested before a decision on the disposition of the batch is made.

A

SINGLE

24
Q

In _________, a second sample for inspection / testing is permitted if the FIRST FAILS, but the observed no. of defective will apply to the two samples combined.

A

DOUBLE SAMPLING

25
Q

rejected if it contains 4% or more defective tablets

A

UNACCEPTABLE QUALITY LEVEL (UQL)

26
Q

if it contains 2% or less defective tablets

A

ACCEPTABLE QUALITY LEVEL (AQL)

27
Q

is the RISK OF ERROR on the probability of REJECTING A GOOD BATCH

A

PRODUCER’S RISK

28
Q

is the risk of error on the probability of ACCEPTING A DEFECTIVE BATCH

A

CONSUMER’S RISK

29
Q

A _______ is one that has been shown by appropriate scientific means to be UNIFORM, within a lot, consistent within lots, and meeting designed criteria WITHIN DEFINED LIMITS.

A

VALIDATED PRODUCT

30
Q

samplings are taken with a sample size AS SMALL AS ONE UNIT.

A

HOMOGENEOUS DOSAGE FORMS

31
Q

employed for various pharmaceutical operations and may be used as an aid in controlling and analyzing physical, chemical, analytical and biological parameters

A

CONTROL CHART

32
Q

_____ chart is one in which several samples are tested and distribution of measurements can, in a sense, measure DEGREES OF DEFECTIVENESS.

A

VARIABLE

33
Q

______ chart is one in which each sample inspected is tested to determine whether it CONFORMS TO REQUIREMENTS. It is the so-called “go” or “no-go” situation

A

ATTRIBUTE

34
Q

______ charts are more sensitive than _______ chart

A

VARIABLE, ATTRIBUTE

35
Q

sampling used in CONTROL CHART BY ATTRIBUTES

A

RANDOM SAMPLING

36
Q

the RATIO of the number of DEFECTIVENESS found to the total number of units actually inspected in the batch

A

FRACTION DEFECTIVE

37
Q

the ARITHMETIC AVERAGE of a series of values and is calculated by dividing the sum of such values by the no. of values (N) in the series

A

MEAN / AVERAGE

38
Q

simplest measure of variation

A

RANGE

39
Q

the DIFFERENCE between the HIGHEST and LOWEST VALUE in a series of observations.

A

RANGE

40
Q

The measure of variation most commonly used

A

STANDARD DEVIATION

41
Q

can be described as being concerned w/ the composition of matter & the changes it undergoes.

A

CHEMISTRY

42
Q

is mostly concerned w/ the study of compounds containing the element CARBON.

A

ORGANIC CHEMISTRY

43
Q

is the study of ALL elements & compounds other than organic compounds.

A

INORGANIC CHEMISTRY

44
Q

is the study of the chemistry of BIOLOGICAL PROCESSES, such as the utilization of foods (carbohydrates, proteins & fats) that produce energy & the synthesis of biologically active compounds in living organisms.

A

BIOCHEMISTRY

45
Q

is the study of:
reaction rates – how fast will a reaction go?
mechanisms – what path does a reaction take to get to the
products?
bonding & structure of compounds – how are compounds
formed, & what are their shapes?
thermodynamics – what makes a reaction go & what is the total
energy relationship of a reaction?

A

PHYSICAL CHEMISTRY

46
Q

is the study of:
reaction rates – how fast will a reaction go?
mechanisms – what path does a reaction take to get to the
products?
bonding & structure of compounds – how are compounds
formed, & what are their shapes?
thermodynamics – what makes a reaction go & what is the total
energy relationship of a reaction?

A

PHYSICAL CHEMISTRY

47
Q

is the study of QUALITATIVE (what is present?) & QUANTITATIVE (how much is present?) analysis (examination) of elements & compounds.

A

ANALYTICAL CHEMISTRY

PHARM ANA LEC (11 decks)

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