Testing under more gentle conditions (those recommended for long-term shelf storage) are used to determine a product’s shelf life and expiration dates. Zilker M(1), Sörgel F(2), Holzgrabe U(3). The expiry date should therefore be calculated on a DD/MM/YYYY basis starting from the date of release, or if applicable from the date of production, and rounded up or down to MM/YYYY according to the following example: 14/01/2007 becomes 12/2006 and 15/01/2007 becomes 01/2007. The period between the two dates is called the ‘life period’ or ‘shelf-life’ of the drug. Expiry of first API is Nov 2019. You have to know what is Expiration date: the date when a product will probably not be high quality any more. Pharmaceutical Guidanace April 2, 2016 QA & QC, Quality Assurance, SOP Comments Off on Assigning Manufacturing and Expiry date 1,765 Views Objective: To lay down a procedure for assigning manufacturing and expiry date to the finished products being manufactured. In such scenarios, the medicines typically degrade.

The manufacturing date of the intermediate or the product should be assigned on the basis of the date of charging the project. If no significant change is found in the accelerated conditions then shelf life would depend upon the long-term storage … Head Production department shall be responsible for the implementation of this SOP. No(s); one with expiry Feb 2019 and other with expiry Nov- 2018. For ex. Medicines are made to go through strict stability tests to determine expiry dates. Essentials in Stability Analysis and Expiry Determination Thomas A. Then the finished product shall be assigned expiry date as Nov- 2018. Shelf life is the period of time, from the date of manufacture, that a drug product is expected to remain within its approved product specification while stored under defined conditions. Pharmaceutical Stability Shelf Life August 1, 2010 1 • ICH Guideline Q1A defines “Shelf Life (also referred to as expiration dating period)” as “The shelf life for a pharmaceutical product is the maximum time at which a stability limiting characteristic stays within acceptance criteria. When a drug is exposed to heat, moisture, and humidity, it will result in some changes, usually negative. The expiry date is that point in time when a pharmaceutical product is no longer within acceptable specifications for potency and stability. This SOP is applicable for assigning manufacturing and expiry date to the finished products being manufactured at (Company Name). For Domestic market : Guidelines on packaging for pharmaceutical products Introductory note 120 Glossary 121 1. Expiry date refers to the date by which the product starts losing its quality be it physical attributes like appearance, texture, color as well as it's nutritional quality and by this time it becomes unsafe for consumption. The expiry date should therefore be calculated on a DD/MM/YYYY basis starting from the date of release, or if applicable from the date of production, and rounded up or down to MM/YYYY according to the following example: 14/01/2007 becomes 12/2006 and 15/01/2007 becomes 01/2007.


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