en Original article Original article <p dir="ltr" style="text-align: justify"><strong>Introduction:</strong> Pharmaceutical companies as well as food and cosmetics manufacturers are legally required to provide a shelf-life label on their products packaging as part of their stability study report. There are different recommended software like R software package and SAS which can perform as shelf-life estimating tools for analyzing the data achieved by the stability testing of drugs and vaccines. <strong>Methods:</strong> Recombinant hepatitis B surface antigen vaccine (Pasteur Institute of Iran) was used as a sample for the entire quality control assays according to Pharmacopeia and NIH (National Institute of Health) procedures. For the stability study, full test examinations were done and R software package was applied to estimate the shelf-life. <strong>R</strong><strong>esults: </strong>The results of R software indicated a variety of statistical information which makes the data interpretation more intelligible and apprehensible. <strong>Conclusion:</strong> Based on our results and experience, the best way to obtain a shelf-life or the expiration date is to calculate it manually however, using software such as R can increase the accuracy of the results.</p> ICH, FDA, Hepatitis B vaccine, shelf-life, expiration date. 29 32 http://vacres.pasteur.ac.ir/browse.php?a_code=A-10-1-7&slc_lang=en&sid=1 SM Hosseini No Pasteur Institute of Iran SB Momen No Pasteur Institute of Iran d Doroud d_doroud@yahoo.com No Pasteur Institute of Iran SN Hoseini No Pasteur Institute of Iran K Maboudi No Pasteur Institute of Iran Sh Hadadian hadadian@ yahoo.com Yes Pasteur Institute of Iran