prelim

Question 1

if the sample is a drug

Answer 1

ASSAY

Question 2

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?

Answer 2

QUALITATIVE

Question 3

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

Answer 3

QUANTITATIVE

Question 4

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

Answer 4

QUALITY

Question 5

• 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

Answer 5

QUALITY ASSURANCE

Question 6

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

Answer 6

QUALITY CONTROL

Question 7

statement of ingredients (% age, wt)

Answer 7

FORMULA

Question 8

purity of ingredient

Answer 8

RAW MATERIAL SPECIFICATION

Question 9

step by step method; covers instructions in the production

Answer 9

SOP

Question 10

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

Answer 10

PROXIMATE

Question 11

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

Answer 11

MISCELLANEOUS/SPECIFIC METHOD

Question 12

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

Answer 12

VOLUMETRIC ANALYSIS

Question 13

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

Answer 13

PHYSICOCHEMICAL METHOD

Question 14

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

Answer 14

GRAVIMETRIC ANALYSIS

Question 15

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

Answer 15

SPECIAL METHOD

Question 16

done simultaneously

Answer 16

REPLICATES

Question 17

done at different time

Answer 17

TRIALS

Question 18

high quality chemical for laboratory use (American
Chemical Society)

Answer 18

REAGENT ACS

Question 19

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

Answer 19

GUARANTEED REAGENT

Question 20

more or less similar to ACS

Answer 20

ANALYTICAL REAGENT

Question 21

for titration

Answer 21

PRIMARY STANDARD

Question 22

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

Answer 22

PURIFIED

Question 23

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

Answer 23

LINE

Question 24

chemicals manufactured under cGMP and meet requirements of USP

Answer 24

USP GRADE

Question 25

suitable for general industrial use

Answer 25

TECHNICAL GRADE

Question 26

undesirable characteristics of a product

Answer 26

DEFECTS

Question 27

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

Answer 27

ATTRIBUTE DEFECT

Question 28

measured by instruments (ex: weight, thickness

Answer 28

VARIABLE DEFECT

Question 29

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

Answer 29

CRITICAL DEFECT

Question 30

may render product useless (ex: cracked bottle)

Answer 30

MAJOR DEFECT

Question 31

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

Answer 31

MINOR DEFECT

Question 32

visible (foreign particulate)

Answer 32

OCULAR DEFECT

Question 33

not seen (subpotent)

Answer 33

INTERNAL DEFECT

Question 34

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

Answer 34

PERFORMANCE DEFECT

Question 35

examine raw materials received • conduct physical test for packaging materials

Answer 35

MATERIALS INSPECTION SECTION

Question 36

performs physical and chemical analysis

Answer 36

ANALYTICAL LABORATORY

Question 37

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

Answer 37

BIOLOGICAL TESTING LABORATORY

Question 38

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

Answer 38

ANALYTICAL/RESEARCH DEVELOPMENT

Question 39

Maintain records • Investigate complaints • Maintain and develop SOP

Answer 39

QUALITY COORDINATION OFFICE

Question 40

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

Answer 40

ANALYSIS FUNCTION

Question 41

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

Answer 41

MONITORING FUNCTION

Question 42

all records during course of producing quality controlled product

Answer 42

BATCH RECORD

Question 43

secure a representative samples; sampled from different parts

Answer 43

SAMPLING

Question 44

Finite number of objects selected from a given population

Answer 44

SAMPLE

Question 45

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

Answer 45

PRIMARY PACKAGING COMPONENTS

Question 46

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

Answer 46

SECONDARY PACKAGING

Question 47

vitamins, flavors

Answer 47

6 months

Question 48

dyes

Answer 48

12 months