ICH Q1 Flashcards
(14 cards)
What is ICH Q1 for?
Stability testing of Drug substances and Drug products
What is the purpose of stability testing
To provide evidence of how the quality of a drug substances or drug product varies with time under the influence of environmental and physical factors
Name some of the factors influencing stability
Temperature, humidity, light or agitation
What can stability studies be used to establish?
A re-test period or shelf life for the drug substance or a shelf life for the drug product in the proposed container closure system under recommended storage conditions
How may development studies be used?
To characterise the the physical, chemical or biological changes likely to occur with storage, to establish the degradation profile and intrinsic stability of the product. To confirm or and validate the stability indicating nature of the analytical procedures. To inform specifications and to determine whether exposures to conditions other than those defined in the label are deleterious to the product
What is the purpose of accelerated conditions?
They are intended to increase the rate of degradation, physical change or biochemical changes likely
What can data gained from accelerated studies be used for
To support extrapolation, re-test or shelf life determination and to evaluate the impact of excursions outside the label storage conditions
What are the two categories of stress testing
Stress conditions and forced degradation conditions
What are the conditions of stress condition studies?
More severe than accelerated conditions but not necessarily intended to degrade the sample.
What are the objectives of forced degradation conditions?
Intended to deliberately degrade the sample e.g elevated temperature, humidity, pH, oxidation, agitation and light
When may it be appropriate to establish a more stringent release specification than the shelf life specification?
When a stability indicating critical quality attribute changes over time.
What is old be the purpose of having a more stringent release specification when compared to shelf life specification
To ensure drug substances/ drug product quality is maintained through to end of shelf life
How many batches should be used to establish a shelf-life or retest period for DP/DS
Three primary batches
Sealed glass containers and aluminium/aluminium foils blisters are considered to be what type of containers?
Impermeable and therefore used in formulations sensitive to moisture
