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Shelf Life Estimation of Pharmaceutical Products

Learn how the shelf life of the pharmaceutical products and substances is determined according the ICH guidelines.
All pharmaceutical drugs degrade with the time forming the byproducts. These byproducts may harmful for health of the patients consuming the drug. Shelf life of the pharmaceutical products is the time period for which the product maintains its identity and quality when stored at the conditions defined on the label of the product.

Shelf life in pharmaceuticalsIt is important to set the time frame to consume the pharmaceutical products. ICH Q1E guideline provides guidance for the estimation of the shelf life of the pharmaceutical products and substances. Shelf life is determined after the evaluation of whole stability data of the product.

Minimum data of three batches is used to estimate the shelf life of pharmaceutical products. For the products stored at room temperature the assessment should be started from the occurrence of the significant change in product stored in accelerated conditions. If no significant change is found in the accelerated conditions then shelf life would be depend upon the long term storage conditions data.

If long term and accelerated conditions data shows very little change or no change at all then it might be assumed that the product would be stable during the proposed shelf life period. In this case there is no requirement of the statistical analysis and the justification for the same should be given. In this case the shelf life of the product can be proposed twice but should not be more than 12 months of the period covered by the long term evaluation data.

Related: Impurity Profiling of Drug Substances in Pharmaceuticals

If long term condition or accelerated condition data shows change then statistical analysis is used to estimate the shelf-life of the drug product. When the statistical calculations cannot be done by the data, the shelf life period can be defined 1.5 time of the period covered by the long term data.
When the data is sufficient for the statistical calculations shelf-life would be defined double but not more than 12 months from the period covered by the long term data. Details can be read in ICH Q1E guidelines.

Figure: Layout for the Process of Determination of the Shelf Life of the Pharmaceutical Products.

Shelf life estimation
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question

1 Comment so far : Add yours...

prince naresh said...

Why the intermediate stabilility testing condition was negeleted from the testing of dosage forms during their stability.

Naresh Babu

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