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Manufacture Lab > Labelling > Flashcards

Labelling Flashcards

1
Q

Provision of ADEQUATE INFORMATION and ACCURATE IDENTIFICATION of the pre-packaged for and drugs

A

Labeling

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2
Q

Labeling is a

A

VERY IMPORTANT FEATURE of a finished product

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3
Q

A display of WRITTEN, PRINTED or GRAPHIC MATTER upon the immediate container

A

Label

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4
Q

Everything found on the package should serve a

A

Purpose

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5
Q

Items used or attached to BIND, CLOSE or CONTAIN the drug preparation in the final form.

A

Packaging material

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6
Q

13 digit barcode is for

A

Primary
Secondary

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7
Q

14 digit barcode is for

A

Tertiary

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8
Q

Arrangement in the barcode

A

Country code
Company code
Product code
Check digit

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9
Q

Each barcode has a

A

Single keeping unit (SKU)

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10
Q

Is medical devices INCLUDED as a drug or drug product?

A

No

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11
Q

What does drug or drug product include

A

Herbal or traditional products listed in PNDF

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12
Q

Drug or drug product is also known as

A

Finished product

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13
Q

Ready to be SOLD and MARKETED

A

Finished product

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14
Q

Parts of a label

A

Principal display panel
Information panel

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15
Q

Portion of the label most likely to be SEEN by the consumer

A

Principal display panel

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16
Q

PDPs percentage of the surface area

A

40%

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17
Q

PDP is also known as the

A

Customary view

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18
Q

Right or left of PDP

A

Information panel

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19
Q

A PRIMARY LABEL where all information except PDP is contained

A

Information panel

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20
Q

PDP includes

A

Rx symbol
Generic name
Dosage strength
Dosage form
Pharmacologic category
MAH
Net content

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21
Q

Information panel contains

A

Formulation
Indication
Contraindications, warnings, precautions
Mode of administration/directions for use
Batch/lot number
Manufacture/expiration date
Registration number
(Rx)
Storage conditions

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22
Q

HEIGHT of the Rx symbol

A

Not less than 1/5 of the PDP height

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23
Q

Rx symbol should be printed using

A

Contrasting color

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24
Q

Has the HIGHEST POINT size

A

Generic name

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25
Q

Genetic name should be printed in

A

Full

26
Q

Genetic name is BASED on

A

INN in coordination with WHO
Intentional Nomenclature Name

27
Q

Naming 2/more APIs according to

A

DECREASING dosage strength

28
Q

The genetic name should be ENCLOSED by a

A

OUTLINE BOX to give EMPHASIS

29
Q

It is the COLLECTIVE TERM

A

Generic class name

30
Q

Units for CONCENTRATION

A

Metric system

31
Q

Units for POTENCY

A

International unit

32
Q

Dosage strength includes

A

Concentration
Potency

33
Q

It is always BESIDE the dosage strength

A

Dosage form

34
Q

Company started in the MARKETING AUTHORIZATION responsible for quality and compliance

A

Complete name and address of manufacturer, distributor, trader and repacker (MAH)

35
Q

TOTAL AMOUNT of the DF in a given container

A

Net content

36
Q

The net content should be
Unit
Location

A

Metric system
Right upper side of box/generic name

37
Q

Formulation must include

A

Content in DECREASING PHARMACOLOGIC ACTIVITY
Excipients causing HYPERSENSITIVITY
Alcohol content

38
Q

Formulations included must be responsible for the

A

Therapeutic use

39
Q

Percentage of alcohol used in drugs

A

NMT 15%

40
Q

INTENDED USE

A

Indication

41
Q

Emphasis on the PATIENTS CONDITION

A

Contraindications

42
Q

It is more HAZARDOUS

A

Warnings

43
Q

Specific amount for a particular AGE BRACKET

A

Mode of administration/Dosage and administration

44
Q

Instructions on HOW TO USE

A

Directions for use

45
Q

Batch or lot number is

A

Alpha numeric

46
Q

Expiry date month is up to the

A

Last day

47
Q

What is the expiry date if a reconstituted product is kept in REFRIGERATOR

A

14 days

48
Q

What is the expiry date if a reconstituted product is NOT kept in REFRIGERATOR

A

7 days

49
Q

Number provide upon REGISTRATION FROM FDA

A

Registration number

50
Q

An information for pharmacists

A

Rx label

51
Q

Set of instructions for OPTIMAL CONDITIONS to preserve stability

A

Storage condition

52
Q

The MOLECULE or ION

A

Active moiety

53
Q

Substance or compound INTENDED to be used in the manufacture

A

API

54
Q

Response to a medicine that is NOXIOUS and UNINTENDED

A

ADR

55
Q

Any product of BIOLOGICAL ORIGIN

A

Biological product

56
Q

Name assigned to the product by the MAH

A

Brand name

57
Q

Ingredient added INTENTIONALLY

A

Excipient

58
Q

A PHARMACEUTICAL FORM of an active ingredient or placebo

A

Investigational product

59
Q

PI is for

A

Prescription products

60
Q

PIL

A

Non-prescription and in layman’s term

61
Q

A drug substance that is INACTIVE

A

Prodrug

Manufacture Lab (2 decks)

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