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qc > prelim > Flashcards

prelim Flashcards

1
Q

if the sample is a drug

A

ASSAY

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2
Q

Involves the identification of the following:
• composition determination
• ascertainment of impurities present in a given sample
• Answers the question: WHAT IS PRESENT IN A GIVEN SAMPLE?

A

QUALITATIVE

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3
Q

determination of the proportion of components in a given sample
Answers: HOW MUCH IS
PRESENT IN THE SAMPLE?

A

QUANTITATIVE

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4
Q

Totality of characteristics or features of a product that bears on its capacity to satisfy stated or implied needs

A

QUALITY

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5
Q

• sum total of the organized arrangements made with the object of ensuring that products will be consistently of the quality required by their intended use
• based on process approach
• done before starting a project
• proactive or preventive process to avoid defects

A

QUALITY ASSURANCE

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6
Q

part of GMP concerned with sampling, specifications, testina organization • product based approach
• checks deliverables if it satisfy the quality requirements and specifications of customers
• begins once the product is manufactured

A

QUALITY CONTROL

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7
Q

statement of ingredients (% age, wt)

A

FORMULA

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8
Q

purity of ingredient

A

RAW MATERIAL SPECIFICATION

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9
Q

step by step method; covers instructions in the production

A

SOP

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10
Q

total amount of class or group of active plant principles in a given sample

A

PROXIMATE

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11
Q

involves crude drugs and natural products derived from them
eg. Water content determination,
Ash content, Acid

A

MISCELLANEOUS/SPECIFIC METHOD

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12
Q

the determination of the volume of a solution of known concentration required to react with a given amount of the substance to be analyzed

A

VOLUMETRIC ANALYSIS

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13
Q

based on some specific physical or chemical property/ properties of the substance being analyzed
• involve instrumental techniques such as chromatography,
spectrophotometry, refractometry, polarimetry

A

PHYSICOCHEMICAL METHOD

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14
Q

the separation by extraction, precipitation, or other means of the constituent to be determined either in the natural state or in the form of a definite compound the composition of which is known to the analyst, and the weighing of the resulting product

A

GRAVIMETRIC ANALYSIS

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15
Q

those which require a distinct type of technique such as alkaloidal assaying

A

SPECIAL METHOD

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16
Q

done simultaneously

A

REPLICATES

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17
Q

done at different time

A

TRIALS

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18
Q

high quality chemical for laboratory use (American
Chemical Society)

A

REAGENT ACS

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19
Q

suitable for use in analytical chemistry, products meet or exceed ACS requirement

A

GUARANTEED REAGENT

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20
Q

more or less similar to ACS

A

ANALYTICAL REAGENT

21
Q

for titration

A

PRIMARY STANDARD

22
Q

chemicals of good quality where there are no official standards; usually limited to inorganic chemicals.

A

PURIFIED

23
Q

a line of solvents suitable for histology methods and general laboratory application

A

LINE

24
Q

chemicals manufactured under cGMP and meet requirements of USP

A

USP GRADE

25
Q

suitable for general industrial use

A

TECHNICAL GRADE

26
Q

undesirable characteristics of a product

A

DEFECTS

27
Q

cannot be measured by any instrument (ex: odor, cleanliness)

A

ATTRIBUTE DEFECT

28
Q

measured by instruments (ex: weight, thickness

A

VARIABLE DEFECT

29
Q

endanger life or property, may render product nonfunctional (ex: disintegration time)

A

CRITICAL DEFECT

30
Q

may render product useless (ex: cracked bottle)

A

MAJOR DEFECT

31
Q

does not endanger life nor affect function (ex: label)

A

MINOR DEFECT

32
Q

visible (foreign particulate)

A

OCULAR DEFECT

33
Q

not seen (subpotent)

A

INTERNAL DEFECT

34
Q

a defect in function (ex: suppository that does not melt in body temperature)

A

PERFORMANCE DEFECT

35
Q

examine raw materials received
• conduct physical test for packaging materials

A

MATERIALS INSPECTION SECTION

36
Q

performs physical and chemical analysis

A

ANALYTICAL LABORATORY

37
Q

performs microbiological, pharmacological, strerility and toxicity tests
• conducts environmental monitoring

A

BIOLOGICAL TESTING LABORATORY

38
Q

research development
• validate procedures
• develop new assays
• develop and improve final product

A

ANALYTICAL/RESEARCH DEVELOPMENT

39
Q

Maintain records
• Investigate complaints
• Maintain and develop SOP

A

QUALITY COORDINATION OFFICE

40
Q

• to assure acceptability of product
• all materials are within specifications

A

ANALYSIS FUNCTION

41
Q

• in process testing
• any deviation must be reported
• environmental monitoring

A

MONITORING FUNCTION

42
Q

all records during course of producing quality controlled product

A

BATCH RECORD

43
Q

secure a representative samples; sampled from different parts

A

SAMPLING

44
Q

Finite number of objects selected from a given population

A

SAMPLE

45
Q

direct contact with the product
Ex: Caps, capsules, bottles

A

PRIMARY PACKAGING COMPONENTS

46
Q

Components - do not come in direct contact
Ex: Labels, inserts and cartons

A

SECONDARY PACKAGING

47
Q

vitamins, flavors

A

6 months

48
Q

dyes

A

12 months

qc (4 decks)

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