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level: Level 2

Questions and Answers List

level questions: Level 2

Question	Answer
-It help identify the likely degradation products, which can in turn help establish the DEGRADATION PATHWAYS and the intrinsic stability of the molecule and validate the stability indicating power of the analytical procedures used. -The nature of the __ will depend on the individual drug substance and the type of drug product involved.	Stress Testing
USE OF STRESS TESTING	TO VALIDATE ANALYTICAL PROCEDURES TO IDENTIFY STABILITY-AFFECTING FACTORS TO IDENTIFY POTENTIAL DEGRADANTS TO SELECT MANUFACTURING PROCESS
Simulates the packaging proposed for storage and distribution.	Container Closure System
Stability studies should include testing of those attributes of the drug substance:	physical, chemical, biological, and microbiological
minimum of THREE TIME POINTS, including the initial and final time points (e.g., 0, 3, and 6 months), from a 6-month study is recommended.	Accelerated storage condition
for a drug substance is defined as failure to meet its specification.	“Significant change”
*If long-term studies are conducted at 25°C ± 2°C/60% RH ± 5% RH and “significant change” occurs at any time during 6 months’ testing at the accelerated storage condition, what will happen?	additional testing at the intermediate storage condition should be conducted and evaluated against significant change criteria.
If significant change occurs between __ months testing at the accelerated storage condition, the proposed re-test period should be based on the real time data available at the long term storage condition.	3 and 6 months
If significant change occurs within __ months’ testing at the accelerated storage condition, a discussion should be provided to address the effect of short term excursions outside the label storage condition, e.g., during shipping or handling.	the first 3
It is considered unnecessary to continue to test a drug substance through 6 months when a significant change has occurred __	the first 3 months.
the re-test period should be based on the real time data obtained at the __	long term storage condition.
In the absence of an accelerated storage condition for drug substances intended to be stored in a freezer, __ should be conducted to address the effect of short term excursions outside the proposed label storage condition, e.g., during shipping or handling.	testing on a single batch at an elevated temperature (e.g., 5°C ± 3°C or 25°C ± 2°C) for an appropriate time period
specific instructions should be provided, particularly for drug substances that cannot tolerate freezing.	Statements/Labeling
specific instructions should be provided, particularly for drug substances that cannot tolerate freezing. Terms such as __ should be avoided.	“ambient conditions” or “room temperature”
should be conducted on at least one primary batch of the drug product if appropriate. provided on at least three primary batches of the drug product. should be of the same formulation and packaged in the same container closure system as proposed for marketing. should provide product of the same quality and meeting the same specification as that intended for marketing.	Photostability Testing
A single primary stability batch of the drug product should be tested for __ at the proposed shelf life	antimicrobial preservative effectiveness
When testing at the intermediate storage condition is called for as a result of significant change at the accelerated storage condition, a minimum of __ including the initial and final time points, from a 12- month study is recommended.	four time points,
Stability studies for products stored in impermeable containers can be conducted under	any controlled or ambient humidity condition.
Aqueous-based products packaged in semi-permeable containers should be evaluated for __ in addition to physical, chemical, biological, and microbiological stability. This evaluation can be carried out under conditions of __	potential water loss, low relative humidity
A __% loss in water from its initial value is considered a significant change for a product packaged in a semi permeable container after an equivalent of 3 months’ storage at 40°C/NMT 25%	5
for small containers (1 mL or less) or unit- dose products, a water loss of __ or more after an equivalent of 3 months’ storage at 40° C/NMT 25% RH may be appropriate, if justified.	5%