Storage, transport and distribution Flashcards
What is good distribution practice (GDP)?
GDP is that part of QA which ensures that products are consistently stored, transported and handled under suitable conditions.
What are the possible consequences of inadequately controlled environments?
Ineffective medicines, spoiled produce, damaged materials, and critical equipment failures. May also enable penetration by falsified medicines including illegal counterfeits.
What is the problem associated with storing medicines in the bathroom cabinet?
Too much heat and humidity
Considerable temperature cycling
Why are cotton ball plugs no longer utilised in medicine containers?
Pulls moisture into the bottle and can harbour micro-organisms
What are the six main threats to product quality?
Manufacture Microbiological Biological Chemical Temperature Malicious intent
How should containers be managed before storage?
Removal of outside packaging
De-carding non-film coating cardboard
Wiping down unpackaged items
What bacteria is commonly found on paper and cardboard?
Bacillus and clostridium
What biological issues are associated with the storage of medicines?
Insect and animal control - rodents and insects
Humidity, food sources
What chemical issues are associated with the storage of medicines?
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.
What is the problem with brick walls in a storage room?
Encourage condensation causing humidity.
What are cold chain products?
Medicinal products that need to be stored and shipped at lower than ambient temperatures to assure their quality and efficacy.
What does chapter 8 of the orange guide state regarding storage temperature?
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
What temperature should cold chain products be stored at?
Aim for 5’c (+/-2’c)
What temperature should a blood bank refrigerator be kept at?
2-6’C
How can fridges be monitored?
Monitor by calibrated electronic min/max thermometer with an accuracy of 0.5’C
Should be able to read without opening the door
Why is the MHRA concerned about temperature control?
32% of all critical and major deficiencies seen by GDP inspectors relate to control/monitoring of storage and transportation temperatures
How much space should be left at the bottom of the fridge?
A gap of atleast approx. 3 inches
What are the problems associated with fridges?
- Cleanliness - condensation leads to mould growth
- misuse - over packing, bottom of fridge is not a shelf
- 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
What is the impact of poor seals on fridges?
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
What does the GDP guideline 0.19 state
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.
What is the mean kinetic temperature?
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’
What does paragraph 2 of the falsified medicine directive 2011/62/EUi state?
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
What medicines are most likely to counterfeit?
High value lifestyle drugs e.g. viagra
High value lines e.g. neupogen
High volume, mid priced drugs e.g. augmentin
Outline the FMD directive
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
Counterfeit products will have poorer quality packaging - true/false
False - in many cases the packaging quality is better