Pharmaceutical dossier definition11/7/2023 ![]() ![]() ![]() URS documents are also needed when an existing system must be modified to comply with new regulations. Question 1: What Are the Key Components of a Serialization User Requirement Specification?Ī user requirement specification (URS) document is the first reference document built when a serialization project is initiated. We hope serialization project stakeholders will find these FAQs useful. It has developed this easy-to-understand document to complement (but not replace) regulatory guidance from EMA, FDA, and others with information gathered from the industry. The Workgroup on Serialization was convened to capture the variety of insights gained by those who have implemented serialization. ![]() In a global landscape of constantly evolving regulatory, market, and technical requirements, serialization is, and will likely remain, a complex topic for all industry actors. Serialization is one of the biggest information technology (IT) challenges to affect the pharmaceutical sector in the last decade. Some of those tools are highlighted in the following frequently asked questions (FAQs). For the last three years, the ISPE France Affiliate Serialization Workgroup has produced tools for serialization project stakeholders, which can be helpful for new or renewal projects, within the EU or overseas. To comply with EU serialization regulations, drug manufacturers have been working hard to modernize packaging lines in their production plants with the new printing devices, monitoring systems, and software necessary to serialize drugs subject to prescription and connect labeling information with data repositories at national and European hubs. The unique identifier is then decommissioned when the pack is dispensed within the EU or remarketed to a non-EU country. The repositories system for storing serialization data must be set up by the marketing authorization holders (MAHs) and/or the manufacturers (master data and unique identifier commissioning). Before the medicine is dispensed to the patient, the pharmacist at the dispensary or hospital ensures the medicine’s authenticity in an end-to-end verification system by scanning the data matrix so the unique identifier can be compared with the information uploaded in a secured system of repositories. It must be clearly printed on the packaging and encoded using a standardized data structure and syntax in a two-dimensional, machine readable data matrix (i.e., barcode). The unique identifier is composed of a unique sequence of a product code, a serial number based on a randomized algorithm, a batch number, and expiry date, and, when required by the local authorities, a reimbursement number. The European serialization scheme establishes specific safety features for prescribed medicines: an antitampering device and a unique identifier. ![]()
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