Do you have sufficient stability data to support your expiration date?

ICH guideline Q1A(R2), states that “the purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions”.

stability data for expiration dates

According to the Code of Federal Regulations (21 CFR 211.166 Stability testing), the written stability data program should include the following items:

  • Sample size and test intervals
  • Storage conditions
  • Reliable, meaningful and specific test methods
  • Samples should be in the same container closure system as the marketed product

A company recently received the following observation:

…. Results of stability testing are not used in determining appropriate storage conditions and expiration dates.

Specifically, your firm failed to have adequate stability data to support the expiration dating and storage conditions of …, Lot # ….

a.         The stability test methods and specifications used were not adequately validated to demonstrate that they are appropriate and stability-indicating. For example:

i.          Accelerated stability testing was conducted in lieu of real-time testing, over a … period with the following criteria and specifications, which include but are not limited to: heat resistance and cold resistance as …°C and …°C respectively, as well as … incubation times.

b.         Relative humidity was not adequately examined during this period.

c.         Although potency of the active ingredients was examined during the accelerated stability testing and their results were obtained, no justification was made as to why the results consistently matched the specifications identically.

d.         Stability studies were not conducted at least once annually. For example, the annual study for last year, scheduled in April was abandoned, and no follow up studies have occurred.

As such, there is a lack of valid justification that this accelerated stability testing can support the purported 60-month expiration date for ….

For more information on how to establish and maintain Stability studies refer to the following:

To view more observations pertaining to packaging and labeling, refer to the following GMP Trends® Issues: 1108, 1103, 1094, 1084.

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