Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Qc Lec > unit 6 > Flashcards

unit 6 Flashcards

1
Q

the science, art and technology of enclosing or protecting products for distribution,
storage, sale, and use.

A

Packaging i

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

can be defined as the economical means of providing presentation,
protection, identification, information, convenience, compliance, integrity and stability of the product.

A

Pharmaceutical packaging

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

asses the totality of finish products before reach consumers

A

Packaging control

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

The choice of packaging material will depend upon

A

The degree of protection required
Compatibility with the dosage form
Customer convenience e.g. size, weight of the dosage form
Filling method
Sterilization method to be employed and cost

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Characteristics of Ideal Packaging Materials

A

Must protect the preparation from environmental condition
Must not be reactive with the product
Must not impart taste or odors
Non toxic
FDA- approved
Meet applicable tamper resistancy requirements
Adaptable to commonly employed high-speed packaging equipment

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Purpose: to assess the totality of the product before it reaches the consumers

A

Packaging Control

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

process w/c use review or evaluate the entire product w/ its package/ labelling materials to ensure

A

quality audit

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

Reasons for quality audit

A

Distribution
prevention
correctness
identification

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Ways to prevent mix- ups and errors

A

clearing
separation
separation
Reconcillation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

quality audit s conducted by

A

independent specialist

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Emphasize term of quality control

A

who
cgmp
fda
ich guidelines

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

required that only those products that have meet the standards and specs establish in master formula records shall be distrubuted to the market

A

quality audit

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

proceedings to avoid confusion among personnel in change

A

line clearance

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

blend of diverse elements mistake of taking one thing to another

A

mix-ups

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

caused by cross proximity of products apparatus or instrumental used for multiple products can also due to know no proper segregation and storage of products during packaging and repacking.

A

mix-up and errors

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

involve checking w many cntainers, closure and labels were used during the entire packaging

A

Reconcillation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

various test to ensure that result of important product with comply with specification

A

Packaging Operational Checklist

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

Packaging products

A

containers
strips
closures
labels
package inserts
printing
accessory product unit

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

quality of having uniform structure/ composition

A

Homogeneity

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

used to test integrity of blister pack, package team, small sachets containing tablets

A

Leakers test

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

physical contaminations

A

firewall and glass particles

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

Biological contaminations

A

microorganism such as bacteria, fungi, viruses

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

Chemical contaminations

A

vapor gasses miosture

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

multidose containers that consist of 2 layers provied with perforation, suitable fo conaining single dose of semi solid/ solid preparation

A

Strips/Pouches

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Q

reagent used in leakers test

A

Methylene blue

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
26
Q

hint that it is opened and expose to environmental factors may cause drug degradation

A

Torn strip or pouch

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
27
Q

Packaging Operational Checklist
Products

A
  1. Product mixed with another product
  2. Wrong product/ strength
  3. Homogeneity
  4. Appearance/ color/ odor
  5. Contamination with foreign matter
  6. Fill/ weight/ volume
  7. Heat marks on the product
  8. Freedom from chapping, chips, cracks
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
28
Q

Packaging Operational Checklist Containers

A
  1. Freedom from cracks or chips
  2. Freedom from dents, distortions
  3. Contamination with foreign matter
  4. Leakage
  5. Fill/ weight/ volume
29
Q

Packaging Operational Checklist Strips/ Pouches

A
  1. Product name/ strength
  2. Control code
  3. Expiration
  4. Rx symbol
  5. Leakers in vacuum test
  6. Weak seal
  7. Empty or wrong count
  8. Torn stirp or pouch
  9. Freedom from dust or smears
  10. Correct cutting
  11. Powder in pouches and seals
  12. Perforations of tear patches
  13. Fill/ weight/ volume
30
Q

Packaging Operational Checklist Closures

A
  1. Sealing tightness
  2. Freedom from dust/smears
  3. Crimping
  4. Correct design/color
31
Q

Packaging Operational Checklist Labels

A
  1. Product label/strength
  2. Control code
  3. Expiration date
  4. Rx symbol
  5. Registration #
  6. Correctness of info
  7. Gluing
  8. Alignment
  9. Torn/soiled
  10. Freedom from dust/ smears
  11. Missing info/ label
32
Q

Packaging Operational Checklist Package inserts

A
  1. Incorrect
  2. Missing
  3. Freedom from dirt/ smears
  4. Torn/ soiled
  5. Poorly folded/inserted
33
Q

Packaging Operational Checklist Printing: control code / Exp. Date

A
  1. Incorrect
  2. Missing
  3. Illegible
  4. Mislocation
  5. Smeared
  6. Skipped printing
  7. Misaligned
34
Q

Packaging Operational Checklist Accessories

A
  1. Missing
  2. Mislocation
  3. Freedom from dust and smears
  4. Defective
35
Q

Packaging Operational Checklist Product Unit

A
  1. Incorrect packaging
  2. Empty packaging
  3. Incomplete package content
  4. Incorrect counter per unit
  5. Incorrect count per displace unit
  6. Contamination with foreign material
  7. Wrong size
  8. Improper assembly of printed materials
  9. Improper position of containers
  10. Torn packaging component
  11. Incorrect count per packs/ shipper
  12. Ragged cuts
36
Q

Finished products pending disposition should be separately stored from finished goods which have
been approved by quality control for distribution.

A

Distribution Control

37
Q

vulnerable and critical component of a container as far as stability and compatibility is concerned

A

closure

38
Q

joining 2 or more process of metal or ductile material to hold the other

A

crimping

39
Q

defines the closure, protection and functionality of container while ensuring safety or quality of the drug over the product shelf life

A

Container-closure system

40
Q

externals factors that can cause smudging of labels

A

temperature, moisture, humidity

41
Q

document included in the package of medication that provide information about the drug and use

A

Package inserts

42
Q

automatic product identification and fast recognition and implementation of data

A

Control code

43
Q

additional device included in final package form syrups and liquid DF

A

accessories

44
Q

products that have accessories

A

Device packaging

45
Q

whole unit product

A

Product unit

46
Q

result to deficiency in the quality assurance system packaging and helpful with consequences can create problems that may result in drug recalls

A

bad packaging

47
Q

prevent release of defective product

A

CGP and QC

48
Q

refers to the goods and materials that a business holds for the ultimate purpose of sale
and resale

A

Inventory

49
Q

Significance of Distribution Control

A

Time
§ Uncertainty
§ Economy

50
Q

“Just in time” System

A

Economy

51
Q

receiving goods only as they are needed in the production process, thereby reducing costs
-an inventory strategy companies employ to increase efficiency & decrease waste
-items are delivered only when they are needed & used immediately

A

“Just in time” System

52
Q

Systems of inventory where the
information on the inventory
quantity and availability is
continuously updated

A

Perpetual Inventory

53
Q

Used for relatively inexpensive
goods

A

Periodic Inventory

54
Q

This system achieves a good
control over expensive goods

A

Perpetual Inventory

55
Q

System of inventory which is
updated on a periodic basis,
depending on the manufacturer

A

Periodic Inventory

56
Q

contain the following information: a unique stock card no., product name,
package size, lot number, expiry date, date received, quantity received & the balance of
the stock

A

Stock Card

57
Q

contain the following information: a unique stock card no., product name,
package size, lot number, expiry date, date received, quantity received & the balance of
the stock

A

Stock Card

58
Q

given to the distributor once the product has left the manufacturer’s
warehouse & a stock transfer number should be indicated on the card

A

Stock Card

59
Q

ensure perishable stock and identify by the dates received and moves on to each stage pf production in straight order Stock Card follow

A

FIFO/FEFO

60
Q

“Just in time” System risk

A

out of stock

61
Q

have more benefits in inventory

A

Perpetual Inventory

62
Q

suited with small business inventory

A

Periodic Inventory

63
Q

continuous tract of inventory balances

A

Perpetual Inventory

64
Q

indicate the beginning and ending inventory w/in a given time period

A

stock card

65
Q

aka Lean manufacturing

A

JIT system

66
Q

Distribution cards usually contain the following information: a unique distribution number,
receiver, product name, package size, lot number, quantity of the product received &
expiry date of the product

A

Distribution Card

67
Q

Used as an aid to recall of the product when necessary. In both cases of stock & distribution
card, it is important that qualified personnel sign the papers.

A

Distribution Card

68
Q

encompasses o to manage distribution of product to different pharmaceutical distributors, such as wholesaler and retailers to reach our consumers

A

Distribution Control

69
Q

Always present in labels of either primary or secondary
It is for every approved products

A

REGISTRATION #

Qc Lec (2 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions