qc qa identification

Hannah Angelique Losaria · 100問 · 2年前

通報

問題一覧

totality features or conformance to specifications of a product

quality

quality is everybody's business

total quality management

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

cGMP

regular periodic quality reviews of al registered drug products to verify consistency of the existing process and to ientify product and process improvements

product quality review

a systematic process for the assessment, control, comunication, 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 tests -inspects raw materials, in process products, finished products

quality control

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

quality assurance

udesired characteristic of a raw material or product which indicates that it failed to conform to rhe standards

defect

removal of the product from themarket because it is either defective or harmful

product recall

glucagon, atropine

cat

oxytocin

chicken

PTH

dog

digitalis

pigeon

cod liver oil chorionic gonadotropin corticotropin vasopressin

rats

heparin, protamin sulfate

sheep

insulin, tobocurarine

rabbit

lacrobacillus plantarum

niacin b3, pantothenic acid b5

lactobacillus leichmannii

cobalamin b12

micrococcus luteus

bacitracin

e. coli

chloramphenicol

s. aureus

pen g

k. pneumoniae

streptomycin

b. subtilis med

vancomycin

hydrogen sulfide ts

heavy metals

silver diethyldithiocarbamate ts

arsenic

ammonium thiocanite ts

iron

silver nitrate ts

chloride

barium chloride ts

sulfate

-fastest -used at least 25g of sample

seive analysis

measure of flowability -maximum angle potential between the surface of the pile of the powder and the horizontal plane

angle of repose

measure of compressibility

carr's compressibility index

measure of flowability

hausner's ratio

measure dissolution, disintegration, and bioavailability

hardness

4-10 kg

coated tablet

2-3 kg

sl, chewable

7/8-10kg

buccal

>10kg

mr tablet

crude method/ sharp snap

rule of thumb

spring

stokes monsanto

air pump// hydraulic pressure

strong cobb

pliers llike

pfizer

suspended motor driven weight

erweka

motor-driven anvil cushes tablet horizontally

schleuniger/ heberlein

-identical appearance -faciliitate packaging -accuray for tablet counting machines

thickness

uncoated/ir tablet in water

30mins

capsule in water

2-3 mins

sl tablet in water

2 mins

buccal tablets in water

4 hrs

ECT in water

5 mins

ETC in stimulated gastric fluid

1 hr, no sign

ETC in stimulated intestinal fluid

immediately

• Test for measuring the amount of time required for a given % of drug substance in a tablet to go into solution • Equipment: Vessel with cover, water bath maintained at 37±0.5 °C metallic drive shaft or Paddle.

dissolution

basket

paddle

reciprocating cylinder

flow through cell

paddle over disk

revolving cylinder

reciprocating holder

o ≥ 25mg API per dose and comprising ≥ 25% by wt. of dosage unit o Sample: 20 uncoated compressed tablets

weight variation

o Ensures formulation potency o <25 mg API per dose and comprising <25% by wt. of dosage unit o Sample: 10 units (assay individually); 20 units on retest o Acceptance Criteria: 85-115% API (100±15)

content uniformity

microbial content for opthalmic

sterile

mirobial content for topica dosage forms

no p. auruginosa, s. aureus

microbal content for urethral, vaginal

no molds and yeast

• For semisolids with labeled content of NMT 150g or 150ml • Sample: 10 containers (assay individually); 20 containers on retest 𝑛𝑒𝑡 𝑐𝑜𝑛𝑡𝑒𝑛𝑡 = 𝑖𝑛𝑖𝑡𝑖𝑎𝑙 𝑤𝑒𝑖𝑔ℎ𝑡 − 𝑓𝑖𝑛𝑎𝑙 𝑤𝑒𝑖𝑔ℎ𝑡 • Initial wt.: container with sample (unlabeled, cleansed, then dried) • Final wt.: empty container (heated at 100°C for 5 mins then cooled) • Acceptance Criteria: o Aerosols ▪ <60 g or 60 ml: >90% ▪ ≥ 60 g or 60 ml: > 95% o Non-aerosols ▪ Net content > labeled content

minimum full

• Applicable for liquid products NMT 250mL • Sample size: 10 containers; 20 containers on retest • Procedure: (Angle: 30°; prevent air-bubble formation) • Single unit: drain in 5 seconds • Multiple unit: drain in ≤30 mins

deliverable volume

ideal: 100% with minimum agitation

redispersibility

measure of resistance to flow -should not be too fluid nor too viscous

viscosity

reulsive forces between particles

zeta potential

dye solubility in o/w

amaranth green, methyl red

dye solubility in w/o

sudan red

uv flourencence in w/o

yes

uv flourencence in o/w

conductivity in w/o

conductivity in o/w

yes

cobalt chloride in w/o

blue

cobalt chloride in o/w

pink

b. stearothermophilus

steam/ moist heat

b. subtilis

dry heat

b. pumillus

ionizing radiation

p. diminuta

sterilizing membrane filter

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 · 67問 · 1年前

qc/qa

qc/qa

67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