Storage, transport and distribution

Question 1

What is good distribution practice (GDP)?

Answer 1

GDP is that part of QA which ensures that products are consistently stored, transported and handled under suitable conditions.

Question 2

What are the possible consequences of inadequately controlled environments?

Answer 2

Ineffective medicines, spoiled produce, damaged materials, and critical equipment failures. May also enable penetration by falsified medicines including illegal counterfeits.

Question 3

What is the problem associated with storing medicines in the bathroom cabinet?

Answer 3

Too much heat and humidity

Considerable temperature cycling

Question 4

Why are cotton ball plugs no longer utilised in medicine containers?

Answer 4

Pulls moisture into the bottle and can harbour micro-organisms

Question 5

What are the six main threats to product quality?

Answer 5

Manufacture
Microbiological 
Biological 
Chemical 
Temperature 
Malicious intent

Question 6

How should containers be managed before storage?

Answer 6

Removal of outside packaging
De-carding non-film coating cardboard
Wiping down unpackaged items

Question 7

What bacteria is commonly found on paper and cardboard?

Answer 7

Bacillus and clostridium

Question 8

What biological issues are associated with the storage of medicines?

Answer 8

Insect and animal control - rodents and insects

Humidity, food sources

Question 9

What chemical issues are associated with the storage of medicines?

Answer 9

Medicinal products should be stored separately from other products.

Vapour migration e.g. perfume
Oils and greases can transfer bacteria and spores
Moisture and humidity
Compliance aids such as DDS can compromise this.

Question 10

What is the problem with brick walls in a storage room?

Answer 10

Encourage condensation causing humidity.

Question 11

What are cold chain products?

Answer 11

Medicinal products that need to be stored and shipped at lower than ambient temperatures to assure their quality and efficacy.

Question 12

What does chapter 8 of the orange guide state regarding storage temperature?

Answer 12

Temperatures should be monitored and recorded daily/continuously.
Records should be reviewed regularly
Controlled temperature storage areas should be equipped with temperature recorders
control should be adequate to maintain all parts of the area within the specified temperature
small fridges should be measured continously

Question 13

What temperature should cold chain products be stored at?

Answer 13

Aim for 5’c (+/-2’c)

Question 14

What temperature should a blood bank refrigerator be kept at?

Answer 14

2-6’C

Question 15

How can fridges be monitored?

Answer 15

Monitor by calibrated electronic min/max thermometer with an accuracy of 0.5’C

Should be able to read without opening the door

Question 16

Why is the MHRA concerned about temperature control?

Answer 16

32% of all critical and major deficiencies seen by GDP inspectors relate to control/monitoring of storage and transportation temperatures

Question 17

How much space should be left at the bottom of the fridge?

Answer 17

A gap of atleast approx. 3 inches

Question 18

What are the problems associated with fridges?

Answer 18

1. Cleanliness - condensation leads to mould growth
2. misuse - over packing, bottom of fridge is not a shelf
3. Poor seals -leaky seals prevent vacuum forming in the fridge by contraction air, but moist external air can be drawn in past the seal causing ice to form. Exaggerated temp gradients form in the fridge as temperatures near the gap rise; near the cooling unit temps may fall below zero to compensate

Question 19

What is the impact of poor seals on fridges?

Answer 19

Leaky seals prevent vacuum forming in the fridge by the contraction of air, but moist external air can be drawn in past the seal causing ice to form.
Exaggerated temp gradients form in the fridge as the temperatures near the gap rise; near the cooling unti temperature may fall below zero to compensate

Question 20

What does the GDP guideline 0.19 state

Answer 20

Validated temperature-control systems should be used to ensure correct transport conditions are maintained between the distributor and customer. Customers should be provided with a temperature data to demonstrate that product remained within the required temperature storage conditions during transit, if requested.

Question 21

What is the mean kinetic temperature?

Answer 21

ICH Q1A - a single derived temperature which, if maintained over a defined period, would afford the same thermal challenge to drug as..experienced over a range of higher and lower temperatures’

Question 22

What does paragraph 2 of the falsified medicine directive 2011/62/EUi state?

Answer 22

There is an alarming increase of MPs detected in the union which are falsified in relation to their identity, history or source.
Those products usually contain sub-standard or falsified ingredients, or no ingredients or ingredients including active substances in the wrong dosage thus posing an important threat to public health

Aim of FMD is to verify and authenticate medicines at point of dispensing

Question 23

What medicines are most likely to counterfeit?

Answer 23

High value lifestyle drugs e.g. viagra
High value lines e.g. neupogen
High volume, mid priced drugs e.g. augmentin

Question 24

Outline the FMD directive

Answer 24

Each individual pack with a unique 2D barcoded by the supplier and entered into a data bank.
Tamper-evident seals for all products
All prescription only medicines require authentication
OTC medicines wont require authentication
Dispensing whole packs only

Question 25

Counterfeit products will have poorer quality packaging - true/false

Answer 25

False - in many cases the packaging quality is better