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Pharmaceutics > Introduction > Flashcards

Introduction Flashcards

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
Q

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

A

Good Manufacturing Practice (GMP)

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26
Q

Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use

A

Good Manufacturing Practice (GMP)

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27
Q

holds the drug product and is or may be in direct contact with the drug product

A

CONTAINER

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28
Q

protects from extraneous solids and loss of article

A

Well closed

29
Q

protects from contamination by extraneous liquid, solids, vapors, loss, efflorescence, deliquesence, or evaporation

30
Q

impervious to air or any other gas

31
Q

holds a quantity intended for single dose; cannot be resealed

A

Single dose

32
Q

permits withdrawal of successive portions

A

Multiple dose

33
Q

holds a quantity of a drug intended for admin as a single dose promptly after opening

A

Single unit

34
Q

contains more than a single unit or dose

A

Multiple unit

35
Q

not for under 5 years old

A

Child resistant

36
Q

uses an indication or barrier to entry distinctive by design

A

Tamper evident

37
Q

available in white flint (clear), amber, or colored

38
Q

Type I glass

A

borosilicate

39
Q

type II glass

A

treated SL (exempted form water attack

40
Q

type III glass

41
Q

type IV (nonparenteral)

42
Q

Polyethylene , Polyvinyl chloride, Polypropylene , Polystyrene

43
Q

Problems associated w/ plastic packaging material:

A

Permeability, Leaching, Sorption, Light transmission, Alteration upon storage

44
Q

tin, aluminum, aluminum alloy

45
Q

labels, cartons, layer boards

A

Paper and Board

46
Q

sachets, seals, strips, blisters

A

Films, foils and laminations

47
Q

closure for sterile products

48
Q

Not exceeding 8°C

49
Q

-25 to 10°C

50
Q

2 to 8 °C

A

Refrigerator

51
Q

8 to 15°C

52
Q

2 to 8°C but allows excursions between 0 to 15°C

A

Controlled Room Temperature

53
Q

20 to 25°C (prevailing in working area)

A

Room Temperature

54
Q

30 to 40°C

55
Q

Above 40°C

A

Excessive Heat

56
Q

Does not exceed 40% of average RH at Controlled RT

57
Q

Document that specifies all the tests to be conducted on a product and/or appropriate references containing details of procedure and expected result

58
Q

Document with the results of all tests conducted on material to show compliance or non
compliance with the standard specifications

A

Certificate of Analysis

59
Q

This is concise and precise statement of the ingredients that comprise the product,
together with the percentage and/or weight of each.

60
Q

This should enumerate the characteristics of all the materials that go into the product and the permissible range of purity of each ingredient.

A

Raw material specification

61
Q

This is a step by step method on how to go about a job.

A

Standard Operating Procedure

62
Q

This should cover all characteristics that affect the proper performance, purity, safety and
stability of the product.

A

Finished product specification

63
Q

Finite number of objects selected from a batch

64
Q

Capacity of drug to remain within specifications

65
Q

Minimum Acceptable Potency Level:

A

90% Labeled Potency

66
Q

excess medicaments in manufacturing unstable drugs

67
Q

ointment, suppositories, aerosols, creams, and foams

A

25% (should not exceed)

68
Q

fluids

A

20% (should not exceed)

69
Q

dry DFs

A

25% (should not exceed)

Pharmaceutics (7 decks)

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