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M6: Quality Assurance / Quality Control > QA & QC > Flashcards

QA & QC Flashcards

1
Q

Product-oriented, reactive
Part of GMP concerned with
1. Sampling
2. Inspection
3. Analysis (specifications)
4. Documentation
5. Release procedures
6. Inspection control
7. Environmental monitoring
8. Stock control
Defect IDENTIFICATION

A

Quality Control

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2
Q

Process-oriented, pro-active
1. Prepare SOPs
2. Inventory control
✓ FIFO
✓ Audit
3. Monitoring
Defect PREVENTION

A

Quality Assurance

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3
Q

According to NATURE Defects

A
  1. Ocular
  2. Internal
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4
Q

According to MEASURABILITY Defects

A
  1. Variable
  2. Attribute
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5
Q

According to MAGNITUDE Defects

A
  1. Critical
  2. Major
  3. Minor
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6
Q

Part of validation that involves PROVING that any premises, systems and equipment WORK CORRECTLY and lead to expected result

A

Qualifications

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7
Q

CLOSENESS of results to the TRUE value

A

Accuracy

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8
Q

Degree of AGREEMENT among individual
test results

A

Precision

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9
Q

Contaminant in HANDCREAM

KLEP your HANDS

A

Klebsiella pneumoniae

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10
Q

Contaminant in TalCum powder

A

Clostridium tetani

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11
Q

Contaminant in EYEdrops or ointments

A

Pseudomonas Aeruginosa

Pseudomonas EYEruginosa

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12
Q

Contaminant in Mouthwashes

E mouth to mouth

A

E.coli

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13
Q

Contaminant in IV fluids

PEE

A

Pseudomonas Aeruginosa
Erwinia
Enterobacter

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14
Q

Adventitious agents found to be possible contaminants of biological products

A

Bacteria, Fungi, Viruses

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15
Q

What animal assay use?

Insulin (RABBInsulin)
Tubocurarine (TubocuRABBIT)
Fe Dextran (DexRAN)
**Pyrogen Test

A

Rabbit

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16
Q

What animal assay use?

Safety of Biologicals

A

Guinea Pig

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17
Q

What animal assay use?
Safety & Toxicity test
(plastic tubings, elastumeric plastic)

A

Mouse

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18
Q

What animal assay use?

Digitalis (PIGEtalis)

A

Pigeon

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19
Q

What animal assay use?

Atropine (CATropine)
Glucagon (GluCATgon)

A

Cat

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20
Q

What animal assay use?

Heparin or Protamine SO4
(SHEEParin) (Protamine SHEEPate)

A

Sheep

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21
Q

What animal assay use?

Parathyroid Hormone (ParaDOG)

A

Dog

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22
Q

Stokes-Monsanto (spring) hardness tester

A

Hardness

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23
Q

loss of drug during shipment

A

Friability

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24
Q

*To ensure drug potency
*Tablet dose
o USP 29: 50mg or less
o Revised, 2016: 25 mg or less
*Sample size:
o10 tablets (Limit: 85-115%)
o If not complied, add 20 tablets
(Limit: 75-125%)

A

Content Uniformity

Con10 UniForEity

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25
Q

What TEST?

*Amount of drug DISSOLUTION in body fluids
*Rate limiting step of ABSORPTION
* Temp: 37 ± 0.5°C

A

Dissolution Test

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26
Q

What TEST?

*Time required to RELEASE AI from dosage form
Temp: 37 ± 2°C

Disin2gration

A

Disintegration Test

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27
Q

container to product

A

LeaChing

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28
Q

product to container

A

SorPtion

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29
Q

Highly resistant BOROSILICATE glass
✓ Least reactive glass
✓ Composition: SiO2, BORIC oxide (reduces LEACHING)
✓ Chemically resistant glass (against acid, bases and other solvents)
✓ Has high MELTING POINT (withstand high
temp)
✓ Most common Water for Injection
✓ Unbuffered solutions

A

Powdered Glass Test (Type I)

30
Q

TREATED (SULFURATION) soda lime glass
✓ Composition:
✓ Relatively high Na2O and CaO, but lower than type III = not chemically resistant
✓ Melts at lower temp than type I
✓ Buffered solutions

A

Water Attack Test (Type II)

31
Q

SODALIME glass
✓ Relatively high Na2O and CaO
✓ Melts at lower temp than type I
✓ (MOST COMMON)

A

Powdered Glass Test (Type III)

32
Q

General Purpose Soda Lime Glass
NP
Chemical durability and heat shock not a factor

A

Powdered Glass Test (Type IV)

33
Q

PLASTIC CONTAINERS

◼ Non-autoclavable
◼ Droppers, solid oral preparation container

A

Polyethylene

34
Q

PLASTIC CONTAINERS

◼ Autoclavable

A

Polypropylene

35
Q

PLASTIC CONTAINERS

◼ Transparent
◼ Lustrous
◼ For beverages

A

Polyethylene terephthalate (PET)

36
Q

PLASTIC CONTAINERS

◼ Rigid
◼ Good clarity
◼ Blister packaging

A

Polyvinylchloride (PVC)

37
Q

Errors in estimating expiration date (ED)

Setting the ED too EARLY

A

Alpha error

38
Q

Errors in estimating expiration date (ED)

Setting the ED too LATE

A

Beta-error

39
Q

measures the AMOUNT ( % content) of the component present in a given sample

A

Quantitative analysis

40
Q

Determines what is present in the
sample (COMPOSITION and IDENTITY)

A

Qualitative analysis

41
Q
  • TOTAL class of the plant constituents
  • Example: Alkaloids, glycosides
A

Proximate analysis

42
Q
  • SPECIFIC constituent
  • Example: Atropine, Digoxin
A

Ultimate analysis

43
Q

Aka titration

A

Volumetric analysis

44
Q

Number of moles of solute per LITER of solution

A

Molarity (M)

45
Q

Number of gram or mole EQUIVALENT weights of solute per liter of solution

A

Normality (N)

46
Q

Number of moles of solute per KILOGRAM of solvent

A

Molality (m)

47
Q

Solution of KNOWN concentration and volume

A

Titrant

48
Q
  • Aka titrand
  • Solution of UNKWNOWN concentration, but KNOWN volume
A

Analyte

49
Q
  • Substance that changes color indicating the endpoint
A

Indicator

50
Q
  • mg or g of analyte that is chemically equivalent to 1mL of the titrant
A

Titer

51
Q

wash down drops of standard solution clinging to the tip of the burette:

A

Wash bottle

52
Q

Best for cleaning glass apparatus:

A

Sodium chromate in H2SO4

53
Q

CHANGE IN VALENCE of the reacting substances

A

Reduction-oxidation

54
Q

*INDIRECT titration
*OXIDIZING agents
*Endpoint: DISAPPEARANCE of blue color
(blue -> colorless)

A

IodOmetry

55
Q

*DIRECT titration
*REDUCING agents
*Endpoint: APPEARANCE of blue color
(colorless -> blue)

A

Iodimetry

56
Q

What is the acid necessary for permanganate titrations

A

Sulfuric acid

57
Q

LAWS OF SPECTROSCOPY

Transmittance vs Concentration
(Inversely Proportional) Inc. T = Dec. Conc.

A

Beer’s Law

58
Q

LAWS OF SPECTROSCOPY

Transmittance vs Thickness (viscosity)
(Inversely Proportional) Inc. T = Dec. Thick

A

Lambert’s / Bouguer’s Law

malaki TT ni Lambert

59
Q

LAWS OF SPECTROSCOPY

Transmittance vs Absorbance
Absorbance vs path length, and concentration
(Inversely Proportional Inc. T = Dec. Absorbance

A

Beer-Lambert’s or Beer-Bouguer’s Law

60
Q

TYPES OF SPECTROSCOPY
* Power of TRANSMITTED light
* Chloramphenicol assay: E.coli
* Pen G assay: Staph. aureus
* Assay of ANTIBIOTICS

A

Turbidimetry***

61
Q

TYPES OF SPECTROSCOPY
* power of REFLECTED light
* For SUSPENSION

A

Nephelometry

62
Q

TYPES OF SPECTROSCOPY
* For FLUORESCENTcompounds
* Assay of Vitamin B1and B2
* VISIBLE region

A

Fluorometry

63
Q

TYPES OF SPECTROSCOPY
* FUNCTIONAL GROUP determination

A

IR Spectroscopy

64
Q

LAWS OF SPECTROSCOPY
* FES: Na and K
* AAS (more sensitive): TRACE MINERALS

A

Flame Emission Spectroscopy (FES) and
Atomic Absorption Spectroscopy (AAS)

65
Q

Law of Refraction:

A

Snell’s Law

66
Q

process of converting an optically active (d- or /-) compound into the racemic modification.

A

Racemization

67
Q

N-containing substances
= protein analysis (milk)

A

Kjeldahl method

68
Q

S-containing substances
(sulfonamides)
*aromatic cmpds. with amino group

A

Diazotization method

69
Q
  • Aka Titrimetric method (1a, 1b, 1c)
  • 1° standard = sodium tartrate
  • Reagents:
    o Pyridine
    o Iodine
    o Methanol
    o SO2
A

Method 1 Karl Fischer Method

70
Q
  • Solvent: XYLENE or TOLUENE
A

Method 2 Distillation or Azeotropic method

71
Q

For CRUDE drugs

A

Method 3: Gravimetric Method

M6: Quality Assurance / Quality Control (10 decks)

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