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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
What TEST? *Amount of drug DISSOLUTION in body fluids *Rate limiting step of ABSORPTION * Temp: 37 ± 0.5°C
Dissolution Test
26
What TEST? *Time required to RELEASE AI from dosage form Temp: 37 ± 2°C Disin2gration
Disintegration Test
27
container to product
LeaChing
28
product to container
SorPtion
29
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
Powdered Glass Test (Type I)
30
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
Water Attack Test (Type II)
31
SODALIME glass ✓ Relatively high Na2O and CaO ✓ Melts at lower temp than type I ✓ (MOST COMMON)
Powdered Glass Test (Type III)
32
General Purpose Soda Lime Glass NP Chemical durability and heat shock not a factor
Powdered Glass Test (Type IV)
33
PLASTIC CONTAINERS ◼ Non-autoclavable ◼ Droppers, solid oral preparation container
Polyethylene
34
PLASTIC CONTAINERS ◼ Autoclavable
Polypropylene
35
PLASTIC CONTAINERS ◼ Transparent ◼ Lustrous ◼ For beverages
Polyethylene terephthalate (PET)
36
PLASTIC CONTAINERS ◼ Rigid ◼ Good clarity ◼ Blister packaging
Polyvinylchloride (PVC)
37
Errors in estimating expiration date (ED) Setting the ED too EARLY
Alpha error
38
Errors in estimating expiration date (ED) Setting the ED too LATE
Beta-error
39
measures the AMOUNT ( % content) of the component present in a given sample
Quantitative analysis
40
Determines what is present in the sample (COMPOSITION and IDENTITY)
Qualitative analysis
41
* TOTAL class of the plant constituents * Example: Alkaloids, glycosides
Proximate analysis
42
* SPECIFIC constituent * Example: Atropine, Digoxin
Ultimate analysis
43
Aka titration
Volumetric analysis
44
Number of moles of solute per LITER of solution
Molarity (M)
45
Number of gram or mole EQUIVALENT weights of solute per liter of solution
Normality (N)
46
Number of moles of solute per KILOGRAM of solvent
Molality (m)
47
Solution of KNOWN concentration and volume
Titrant
48
* Aka titrand * Solution of UNKWNOWN concentration, but KNOWN volume
Analyte
49
* Substance that changes color indicating the endpoint
Indicator
50
* mg or g of analyte that is chemically equivalent to 1mL of the titrant
Titer
51
wash down drops of standard solution clinging to the tip of the burette:
Wash bottle
52
Best for cleaning glass apparatus:
Sodium chromate in H2SO4
53
CHANGE IN VALENCE of the reacting substances
Reduction-oxidation
54
*INDIRECT titration *OXIDIZING agents *Endpoint: DISAPPEARANCE of blue color (blue -> colorless)
IodOmetry
55
*DIRECT titration *REDUCING agents *Endpoint: APPEARANCE of blue color (colorless -> blue)
Iodimetry
56
What is the acid necessary for permanganate titrations
Sulfuric acid
57
LAWS OF SPECTROSCOPY Transmittance vs Concentration (Inversely Proportional) Inc. T = Dec. Conc.
Beer’s Law
58
LAWS OF SPECTROSCOPY Transmittance vs Thickness (viscosity) (Inversely Proportional) Inc. T = Dec. Thick
Lambert’s / Bouguer’s Law malaki TT ni Lambert
59
LAWS OF SPECTROSCOPY Transmittance vs Absorbance Absorbance vs path length, and concentration (Inversely Proportional Inc. T = Dec. Absorbance
Beer-Lambert’s or Beer-Bouguer’s Law
60
TYPES OF SPECTROSCOPY * Power of TRANSMITTED light * Chloramphenicol assay: E.coli * Pen G assay: Staph. aureus * Assay of ANTIBIOTICS
Turbidimetry***
61
TYPES OF SPECTROSCOPY * power of REFLECTED light * For SUSPENSION
Nephelometry
62
TYPES OF SPECTROSCOPY * For FLUORESCENTcompounds * Assay of Vitamin B1and B2 * VISIBLE region
Fluorometry
63
TYPES OF SPECTROSCOPY * FUNCTIONAL GROUP determination
IR Spectroscopy
64
LAWS OF SPECTROSCOPY * FES: Na and K * AAS (more sensitive): TRACE MINERALS
Flame Emission Spectroscopy (FES) and Atomic Absorption Spectroscopy (AAS)
65
Law of Refraction:
Snell's Law
66
process of converting an optically active (d- or /-) compound into the racemic modification.
Racemization
67
N-containing substances = protein analysis (milk)
Kjeldahl method
68
S-containing substances (sulfonamides) *aromatic cmpds. with amino group
Diazotization method
69
* Aka Titrimetric method (1a, 1b, 1c) * 1° standard = sodium tartrate * Reagents: o Pyridine o Iodine o Methanol o SO2
Method 1 Karl Fischer Method
70
* Solvent: XYLENE or TOLUENE
Method 2 Distillation or Azeotropic method
71
For CRUDE drugs
Method 3: Gravimetric Method

M6: Quality Assurance / Quality Control (10 decks)

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