ICH Guideline: Q1A (R2) : Stability testing of new drug substances and products
ICH : International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Brief About ICH Guideline: Q1A (R2) :Stability testing of new drug substances and products
Application within the three regions of the EC, Japan, and the United States.
Purpose:
To check stability testing is to provide suggestions on how the quality of a drug substance or drug product differs with time under the effect of a variety of environmental factors such as temperature, humidity, & light, and to establish a re-test period for the drug substance or shelf life for the drug product and suggest storage conditions.
Drug substances proposed for storage in a refrigerator
Study
Storage condition
Min. time period performed/covered by data at submission
Long term*
5°C ± 3°C
12 months
Accelerated
25°C ± 2°C/60% RH ± 5% RH
6 months
Drug substances proposed for storage in a freezer
Study
Storage condition
Min. time period performed/covered by data at submission
Long term*
– 20°C ± 5°C
12 months
In the absence of an accelerated storage condition for drug substances (API) should be planned to store in a freezer, testing on a single batch at an elevated temperature (e.g., 5°C ± 3°C or 25°C ± 2°C) for a proper time period should be conducted to address the effect of short-term excursions outside the proposed label storage condition, e.g., during shipping or handling.
Data from stability studies should be on at least three primary batches of the drug product.
The primary batches should be of the same formulation and packaging system as proposed for marketing purposes.
Testing Frequency as per ICH Guideline
Long term storagecondition should be every 3 months over the 1st year, every 6 months over the 2nd year, and annually subsequently through the proposed shelf life.
Time Point: 0M, 3M, 6M, 9M, 12M, 24M, 36M
Accelerated storage condition, a minimum of 3(three) time points, including the initial and final time points (e.g., 0M, 3M, and 6 months), from a 6-month study, is advisable.
Time Point: 0M, 3M, 6M.
Intermediate storage condition is called for as a result of significant change at the accelerated storage condition, a min. of four-time points, including the initial and final time points (e.g., 0, 6, 9, 12 months), from a 12- month study is advisable.
Time Point: 0M, 6M, 9M, 12M.
Pilot scale Batch: A batch of a drug substance or drug product mfg. by a procedure fully demonstrative of and pretending that to be applied to a full production scale batch. For solid oral dosage forms, a pilot-scale is generally, at a min., one-tenth that of a full production scale or 1 Lakh tablets or capsules, whichever is the larger.