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 retest period for the drug substance or a shelf life for the drug product and recommended storage conditions.
According to the Code of Federal Regulations (21 CFR 211.166 Stability testing), there shall be a written testing program designed to assess the stability characteristics of drug products. The results of such testing shall be used in determining appropriate storage conditions and expiration dates. The program should include:
- Sample size and test intervals
- Storage conditions for samples retained for testing;
- Reliable, meaningful, and specific test methods;
- Testing of the drug product in the same container-closure system as that in which the drug product is marketed;
A company recently received the following observation:
…. The written testing program is not followed.
Specifically, despite the general requirements of SOP …, “Stability Coordination Program” , and specific requirements of Stability Protocol …, no impurity testing of … capsule Batch #’s … were performed thru … stability time points. The stability data summaries for both Batch #’s … from the firm’s …. Software identifies initial release testing on 4 years ago and no subsequent testing until 3 years ago. No laboratory investigation or other quality event was initiated for failure to execute stability testing of … capsule Batch #’s … in accordance with established long-term testing frequencies.
For more information on how to establish a stability program, refer to FDA Guidance documents: Guidance for Industry Q1A(R2) Stability Testing of New Drug Substances and Products, Guidance for Industry Q1E Evaluation of Stability Data, Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products and many more found on the FDA’s guidance document page.
Stay in Compliance! Subscribe today!