qc/qa

Hannah Angelique Losaria · 100問 · 2年前

通報

問題一覧

totality features or conformmance to specifications of a product

quality

quality is everybody's business

total quality management

part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate for their intended use

cGMP

regular periodic quality reviews of all registereddrug products to verify consistency of the existing process and to identify product and process improvements

product quality review

a systematic process for the assessment, control, communication, and review of risks to the quality of the product

quality risk management

selecting appropriate number from the population

sampling

contains the detailed requirements and must be confirmed

specification

-conducts the required test -inspects raw materials, in-process produtcs, fiinished products

quality control

-audit and monitoring -ensures policies are followed -cooperates with regulatory agencies -prepares SOP

qquality assurance

undesirable characteristics of a raw material or product which indicates that it failed t conform to the standard

defect

defect is visible

occular

defect is not visible

internaal

funtional defect

performance

directly measured by instruments; height, eight, concentration, thickness, volume

variable

cannot b directly measured; color, density

attribute

no harm to consumer, no problem in function

minnor

no harm to consumer, product is useless

major

harms consumer, product is useless

critical

removal of the product from the market because it is either defective of harmful

product recall

may cause death o serious adverse health consequences

class 1

ma cause temporary/ medically eversible adverse health consequences

class 2

not likely to cause adverse health consequences

class 3

-extent to which a product remains stable and within specifications -retains original characterisics nlt 90%

stability

period of time during which a product is expected to remain within specification

shelf life

date beyond which product loses stability and after whic it mus not be used

expiration date

-conducte under normal conditions -testing period: 0,3,6,9,12,15,18,24,3

long term

-designed to increase the rate of chemical degradationby using exagerrated storage conditions -testing period:0,3,6

accelerated

-elucidates the intrinsic stability of the drug substance and identify the likely degradation products -ccarried out uner more severe conditions

stress testing

glucagon, atropine

cat

oxytocin

chicken

PTH

dog

digitalis

[igeon

cod liver oil chorionic gonadotropin corticotropin vasopressin

rats

heparin, protamin sulfate

sheep

insulin, tobocurarine

rabbit

systemic injection test -parenteral containers

albino mice

intracutaneous tets -parenteral containers

albino rabbits

eye irritation test -opthalmic cntainers

albino rabbits

implantation test -material in direct contact with tissues

rabbits

heavy metals

hydrogen sulfide ts

arsenic

silver diethyldithiocarbamate ts

iron

ammonium thiocyanate ts

chloride

silver nitrate ts

sulfate

barium chloride ts

2 tangents seprated by the longest distance

feret

distance thatwill bisent the particles

martin

-diameter of the circle that will enclose the particles -same as field microscope

projected areaof the circle

sieve #

the square openings in every linear inch of the seive

retained by #20 seive

coarse

passes #20 but not #40 seive

good

pases #40 seive

fine

method 1 of bulk density

graduated cylinder

method 2 of bulk density

scott vilumeter

method 3 of bulk density

vessel

method 1 of tapped density

graduated cyliner

mmethod 2 of tapped density

graduated cyliinder

method 3 of tapped density

vessel

-measure of flowability -maximum angle possible between the surface of the pile of powder nd he horiizontal plane

angle of repose

measure of compressibility

carr's compressibility index

measure of flowability

hausner's ratio

measure of dissolution, disintegration, and bioavailablity

hardness

crude method/ sharp snap (acceptable)

rule oof thumb

spring

stokes (monsanto)

air pump/ hydraulic pressure

strong cobb

pliers (like)

pfizer

suspended motor-driven weight

erweka

motor driven anvil crushes tablet horizontally; most widely use (eliminates operator vaiability)

schleuniger/ heberlein

gastro

gastro

100問 • 2年前

Hannah Angelique Losaria · 7問 · 2年前

gastro m

gastro m

7問 • 2年前

Hannah Angelique Losaria · 13問 · 2年前

lab

lab

13問 • 2年前

Hannah Angelique Losaria · 94問 · 2年前

94問 • 2年前

Hannah Angelique Losaria · 88問 · 2年前

88問 • 2年前

Hannah Angelique Losaria · 50問 · 2年前

poisons

poisons

50問 • 2年前

Hannah Angelique Losaria · 19問 · 2年前

lec

lec

19問 • 2年前

Hannah Angelique Losaria · 16問 · 2年前

exam

exam

16問 • 2年前

Hannah Angelique Losaria · 41問 · 2年前

spec

spec

41問 • 2年前

Hannah Angelique Losaria · 55問 · 1年前

midterm

midterm

55問 • 1年前

Hannah Angelique Losaria · 54問 · 1年前

PHYSICAL PHARMACY

PHYSICAL PHARMACY

54問 • 1年前

Hannah Angelique Losaria · 29問 · 1年前

PHYSICAL PHARMACY II

PHYSICAL PHARMACY II

29問 • 1年前

Hannah Angelique Losaria · 33問 · 1年前

DDS

DDS

33問 • 1年前

Hannah Angelique Losaria · 22問 · 1年前

hallucinogens

hallucinogens

22問 • 1年前

Hannah Angelique Losaria · 42問 · 1年前

non volatile poisons

non volatile poisons

42問 • 1年前

Hannah Angelique Losaria · 63問 · 1年前

endterm

endterm

63問 • 1年前

Hannah Angelique Losaria · 17問 · 1年前

q3 endterm

q3 endterm

17問 • 1年前

Hannah Angelique Losaria · 65問 · 1年前

mockboard 2019

mockboard 2019

65問 • 1年前

Hannah Angelique Losaria · 39問 · 1年前

mockboard 2019 II

mockboard 2019 II

39問 • 1年前

Hannah Angelique Losaria · 36問 · 1年前

miss mel reviewer

miss mel reviewer

36問 • 1年前

Hannah Angelique Losaria · 9問 · 1年前

miss roma high yield

miss roma high yield

9問 • 1年前

Hannah Angelique Losaria · 12問 · 1年前

micro highlights

micro highlights

12問 • 1年前

Hannah Angelique Losaria · 24問 · 1年前

module 6 AUgdguwegfiuwegfu

module 6 AUgdguwegfiuwegfu

24問 • 1年前

Hannah Angelique Losaria · 75問 · 1年前

mod6 sure

mod6 sure

75問 • 1年前

manufacturing

manufacturing

Hannah Angelique Losaria · 94問 · 1年前

module 5

module 5

94問 • 1年前

Hannah Angelique Losaria · 98問 · 1年前

mod5

mod5

98問 • 1年前

5555555555

5555555555

brex

brex

Hannah Angelique Losaria · 44問 · 1年前

mod4

mod4

44問 • 1年前

Hannah Angelique Losaria · 69問 · 1年前

tox lab

tox lab

69問 • 1年前

Hannah Angelique Losaria · 59問 · 1年前

biopharmaceutics

biopharmaceutics

59問 • 1年前

Hannah Angelique Losaria · 86問 · 1年前

toxicology

toxicology

86問 • 1年前

Hannah Angelique Losaria · 49問 · 1年前

non volatile

non volatile

49問 • 1年前

Hannah Angelique Losaria · 15問 · 1年前

gosel and bricker

gosel and bricker

15問 • 1年前

Hannah Angelique Losaria · 19問 · 1年前

management of ADRs bariles

management of ADRs bariles

19問 • 1年前

Hannah Angelique Losaria · 16問 · 1年前

quiz 4

quiz 4

16問 • 1年前

Hannah Angelique Losaria · 63問 · 1年前

pcol miss gift exam

pcol miss gift exam

63問 • 1年前

Hannah Angelique Losaria · 27問 · 1年前

expirement 2- antidotes

expirement 2- antidotes

27問 • 1年前

Hannah Angelique Losaria · 28問 · 1年前

volatile poisons

volatile poisons

28問 • 1年前

Hannah Angelique Losaria · 37問 · 1年前

Drugs acting on the central nercous sytem

Drugs acting on the central nercous sytem

37問 • 1年前

Hannah Angelique Losaria · 20問 · 1年前

anti arrhythmic drugs

anti arrhythmic drugs

20問 • 1年前

Hannah Angelique Losaria · 17問 · 1年前

antiplatelet drugs

antiplatelet drugs

17問 • 1年前

Hannah Angelique Losaria · 31問 · 1年前

Cardiovascular Drugs

Cardiovascular Drugs

31問 • 1年前

Hannah Angelique Losaria · 26問 · 1年前

barbiturates

barbiturates

26問 • 1年前

Hannah Angelique Losaria · 34問 · 1年前

physical pharmacy

physical pharmacy

34問 • 1年前

plasma

plasma

Hannah Angelique Losaria · 73問 · 1年前

endterm

endterm

73問 • 1年前

Hannah Angelique Losaria · 55問 · 1年前

juris

juris

55問 • 1年前

dds

dds

Hannah Angelique Losaria · 92問 · 1年前

92問 • 1年前

Hannah Angelique Losaria · 19問 · 1年前

dddssss

dddssss

19問 • 1年前

Hannah Angelique Losaria · 59問 · 1年前

manuf

manuf

59問 • 1年前

Hannah Angelique Losaria · 83問 · 1年前

qc qa identification

qc qa identification

83問 • 1年前

quali/ quanti ppt

quali/ quanti ppt

Hannah Angelique Losaria · 23問 · 1年前

quali/quanti 2

quali/quanti 2

23問 • 1年前

Hannah Angelique Losaria · 68問 · 1年前

quali quanti identification

quali quanti identification

68問 • 1年前

Hannah Angelique Losaria · 37問 · 1年前

microbiology: introduction and bacterial anatomy

microbiology: introduction and bacterial anatomy

37問 • 1年前

Hannah Angelique Losaria · 60問 · 1年前

mocrobiology: bacterial stain, nutrition, bacterial recombination, growth phrases, microbial growth factor, culture media

mocrobiology: bacterial stain, nutrition, bacterial recombination, growth phrases, microbial growth factor, culture media

60問 • 1年前

Hannah Angelique Losaria · 28問 · 1年前

microbiology: bacteriology part 1

microbiology: bacteriology part 1

28問 • 1年前

Hannah Angelique Losaria · 48問 · 1年前

microbiology: bacteriology part 2

microbiology: bacteriology part 2

48問 • 1年前

Hannah Angelique Losaria · 20問 · 1年前

microbiology: mycology

microbiology: mycology

20問 • 1年前

Hannah Angelique Losaria · 48問 · 1年前

microbio identification 1

microbio identification 1

48問 • 1年前

Hannah Angelique Losaria · 38問 · 1年前

miss gift

miss gift

38問 • 1年前

Hannah Angelique Losaria · 21問 · 1年前

microbiology 2

microbiology 2

21問 • 1年前

Hannah Angelique Losaria · 18問 · 1年前

microbio 3

microbio 3

18問 • 1年前

microbio 4

microbio 4

Hannah Angelique Losaria · 30問 · 1年前

microbio anatomy

microbio anatomy

30問 • 1年前

Hannah Angelique Losaria · 37問 · 1年前

Drugs acting on the central nercous sytem

Drugs acting on the central nercous sytem

37問 • 1年前

Hannah Angelique Losaria · 17問 · 1年前

microbio5

microbio5

17問 • 1年前

Hannah Angelique Losaria · 13問 · 1年前

microbio6

microbio6

13問 • 1年前

Hannah Angelique Losaria · 34問 · 1年前

pub health 1

pub health 1

34問 • 1年前

Hannah Angelique Losaria · 30問 · 1年前

microbio7

microbio7

30問 • 1年前

Hannah Angelique Losaria · 31問 · 1年前

public health

public health

31問 • 1年前

Hannah Angelique Losaria · 40問 · 1年前

pacop

pacop

40問 • 1年前

Hannah Angelique Losaria · 98問 · 1年前

inorganic pharmaceutical pharmacy

inorganic pharmaceutical pharmacy

98問 • 1年前

transition metal iron triad FE CO NI

transition metal iron triad FE CO NI

Hannah Angelique Losaria · 8問 · 1年前

licensing

licensing

8問 • 1年前

Hannah Angelique Losaria · 26問 · 1年前

most common side effects

most common side effects

26問 • 1年前

chemistry people

chemistry people

pharmacognosy people

pharmacognosy people

Hannah Angelique Losaria · 29問 · 1年前

drug of choice

drug of choice

29問 • 1年前

Hannah Angelique Losaria · 19問 · 1年前

common antidotes

common antidotes

19問 • 1年前

Hannah Angelique Losaria · 25問 · 1年前

vitamin functions and deficiencies

vitamin functions and deficiencies

25問 • 1年前

Hannah Angelique Losaria · 97問 · 1年前

inorganic pharmaceutical pharmacy 2

inorganic pharmaceutical pharmacy 2

97問 • 1年前

Hannah Angelique Losaria · 42問 · 1年前

42問 • 1年前

Hannah Angelique Losaria · 62問 · 1年前

62問 • 1年前

Hannah Angelique Losaria · 48問 · 1年前

inorganic pharm chem 3

inorganic pharm chem 3

48問 • 1年前

Hannah Angelique Losaria · 66問 · 1年前

66問 • 1年前

Hannah Angelique Losaria · 60問 · 1年前

60問 • 1年前

Hannah Angelique Losaria · 43問 · 1年前

43問 • 1年前

Hannah Angelique Losaria · 79問 · 1年前

79問 • 1年前