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Pharmaceutics > Introduction > Flashcards

Introduction Flashcards

(69 cards)

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1
Q

Article intended for the use in diagnosis, mitigation, cure, treatment, or prevent ion of disease in man/ animals

A

DRUG

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2
Q

Article (other than food) intended to affect the structure of any function of the body of human beings or animals

A

DRUG

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3
Q

Component which produces pharmacologic activity (Active Pharmaceutical Ingredient)

A

DRUG

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4
Q

Therapeutic moiety

A

DRUG

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5
Q

Inactive ingredient present in DF

A

EXCIPIENTS

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6
Q

Formulation containing a specific quantity of AI(s) in combination with one or more excipients

A

DOSAGE FORM

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7
Q

Final dosage form that contains the API, generally, but not necessarily, in association with other ingredients

A

DRUG PRODUCT/MEDICINE

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8
Q

Physical carriers used to deliver medications to specific areas

A

DRUG DELIVERY SYSTEMS

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9
Q

Means of administering drugs to the body in a safe, efficient, reproducible and convenient manner

A

DRUG DELIVERY SYSTEMS

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10
Q

Natural products should be free from:

A

Salmonella spp.

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11
Q

Oral Solutions and suspensions should be free from:

A

E. coli.

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12
Q

Topical products must be free from:

A

Pseudomonas aeruginosa

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13
Q

Urethral, vaginal and rectal should be free from:

A

total microbial count

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14
Q

high solubility, high permeability

A

class 1

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15
Q

low solubility, high permeability

A

class 2

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16
Q

high solubility, low permeability

A

class 3

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17
Q

low solubility, low permeability

A

class 4

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18
Q

The complete set of activities to produce a drug that comprise production and QC from dispensing of materials to the release for distribution of the finished product

A

Manufacturing

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19
Q

any organization or company involved in the manuf, import, packaging an d/or distribution of drugs or
medicines

A

Drug Establishment

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20
Q

Production of drug

A

Manufacturer

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21
Q

Registered owner, subcontracts the manufacturer, may

also engage in distribution and marketing

A

Trader

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22
Q

Imports/exports for own use or wholesale distribution

to other establishments

A

Distributor/

Importer/Exporter

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23
Q

Procures from a local establishment for local

distribution on wholesale basis

A

Distributor/
Wholesaler
Procures

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24
Q

meaning of PIC/S GMP 2009

A

Pharmaceutical Inspection Convention/ Co operation Scheme

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25
System of QA aimed at ensuring that products are consistently manufactured to a quality appropriate for their intended use and is concerned with both manuf and QC processes and procedures
Good Manufacturing Practice (GMP)
26
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use
Good Manufacturing Practice (GMP)
27
holds the drug product and is or may be in direct contact with the drug product
CONTAINER
28
protects from extraneous solids and loss of article
Well closed
29
protects from contamination by extraneous liquid, solids, vapors, loss, efflorescence, deliquesence, or evaporation
Tight
30
impervious to air or any other gas
Hermetic
31
holds a quantity intended for single dose; cannot be resealed
Single dose
32
permits withdrawal of successive portions
Multiple dose
33
holds a quantity of a drug intended for admin as a single dose promptly after opening
Single unit
34
contains more than a single unit or dose
Multiple unit
35
not for under 5 years old
Child resistant
36
uses an indication or barrier to entry distinctive by design
Tamper evident
37
available in white flint (clear), amber, or colored
Glass
38
Type I glass
borosilicate
39
type II glass
treated SL (exempted form water attack
40
type III glass
soda lime
41
type IV (nonparenteral)
gen. SL
42
Polyethylene , Polyvinyl chloride, Polypropylene , Polystyrene
Plastic
43
Problems associated w/ plastic packaging material:
Permeability, Leaching, Sorption, Light transmission, Alteration upon storage
44
tin, aluminum, aluminum alloy
Metal
45
labels, cartons, layer boards
Paper and Board
46
sachets, seals, strips, blisters
Films, foils and laminations
47
closure for sterile products
Rubber
48
Not exceeding 8°C
Cold
49
-25 to 10°C
Freezer
50
2 to 8 °C
Refrigerator
51
8 to 15°C
Cool
52
2 to 8°C but allows excursions between 0 to 15°C
Controlled Room Temperature
53
20 to 25°C (prevailing in working area)
Room Temperature
54
30 to 40°C
Warm
55
Above 40°C
Excessive Heat
56
Does not exceed 40% of average RH at Controlled RT
Dry Place
57
Document that specifies all the tests to be conducted on a product and/or appropriate references containing details of procedure and expected result
Monograph
58
Document with the results of all tests conducted on material to show compliance or non compliance with the standard specifications
Certificate of Analysis
59
This is concise and precise statement of the ingredients that comprise the product, together with the percentage and/or weight of each.
Formula
60
This should enumerate the characteristics of all the materials that go into the product and the permissible range of purity of each ingredient.
Raw material specification
61
This is a step by step method on how to go about a job.
Standard Operating Procedure
62
This should cover all characteristics that affect the proper performance, purity, safety and stability of the product.
Finished product specification
63
Finite number of objects selected from a batch
Sample
64
Capacity of drug to remain within specifications
STABILITY
65
Minimum Acceptable Potency Level:
90% Labeled Potency
66
excess medicaments in manufacturing unstable drugs
OVERAGE
67
ointment, suppositories, aerosols, creams, and foams
25% (should not exceed)
68
fluids
20% (should not exceed)
69
dry DFs
25% (should not exceed)

Pharmaceutics (7 decks)

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