Storage, Transport & Distribution

Question 1

What ‘Good Distribution Practice (GDP)’

Answer 1

The part of quality assurance (QA) which ensures that products are consistently:
- Stored
- Transported
- Handled
Under suitable conditions

Question 2

Inadequately controlled environments can lead to…

Answer 2

Ineffective medicines, (spoiled produce, damaged materials and critical equipment failures)

Question 3

What are the main environmental factors that can lead to the damaging of medicines?

Answer 3

Heat, air, light and moisture

Question 4

What are the main types of threat to Quality and Patient safety

Answer 4

Manufacture
Microbiological
Biological
Chemical
Temperature
Sinister - malicious intent

Question 5

Microbiological threats

Answer 5

Contamination

• Infection
• Spoilage (rendered unfit for use)

How?

• Dusts, dirt
• Static
• Damage
• Misuse

Question 6

Biological threats

Answer 6

Insect and animal control essential

• Rodents
• Insects

Control

• Humidity
• Food sources
• Clean and tidy
• Pest control measures - traps etc

Question 7

What is the Continuum of Cleanliness

Answer 7

Incoming containers of medicinal products should be cleaned, if necessary, before storage

Progressive removal of layers
- Removal of outside packaging
Unpacking
Wiping down unpackaged items

Involves everyone

Question 8

Chemical threats

Answer 8

Medicinal products should be stored separately from other products
- Vapour migration (e.g. perfume)
- Oils and greases
- Moisture/humidity
Packaging integrity maintained

Question 9

Temperature threats

Answer 9

Cold Chain Products

• Medicinal products that need to be stored and shipped at lower than ambient temperatures to assure their quality and efficacy
• Considerable growth in number of temperature-sensitive products
• Some drugs “can become toxic if frozen… or lose efficacy very quickly if warmed”

Question 10

What are Cold Chain Products?

Answer 10

Some cold chain drugs are ‘high risk’ of damage from freezing as well as elevated temperatures

• Vaccines
• Insulin
• PN
• Biotech medicines
• Blood products

Question 11

How often should storage temperatures be monitored?

Answer 11

Daily

Question 12

What temperature does a Pharmaceutical refrigerator operate at?

Answer 12

2 to 8 C

Question 13

What temperature does a Blood bank refrigerator operate at?

Answer 13

2 to 6 C

Question 14

What are the most common issues associated with temperature mapping?

Answer 14

Location of probe/data logger
- Air or sample pack?
- Worst case scenario
- Smallest practical pack (more reactive to changes)
- Avoid occlusion/obstruction
Relevance of room temp?

Question 15

What are the most common issues associated with fridges?

Answer 15

Cleanliness
- Condensation leads to mould growth
Misuse
- Bottom of refrigerator is not a shelf
Poor Seals
- Prevent vacuum forming
- Can cause ice to form

Question 16

What matters must be considered in Cold Chain Transport?

Answer 16

Nature of product
Labelled storage requirements/associated warnings
Sensitivity of product to temperature extremes
Likely periods of exposure to temperatures outside the labelled storage requirements
Maximum and minimum temperatures
Number and nature of stages in the chain
Number of drop-off points
Competence

Question 17

What medicines are most likely to be counterfeit?

Answer 17

High value lifestyle drugs
High value lines
High volume, mid priced drugs

Question 18

Transport threats

Answer 18

Temperature maintenance
Damage/leakage
Exposure risks
- Specific training needed