Quality assurance managers in pharmaceutical companies play an essential role. As an intersection between the various departments, they make a crucial contribution to the smooth running of the company. In addition to monitoring production processes, actual quality management, and many other tasks, serialization management is thus sometimes treated somewhat neglectfully. The reasons for this are […]
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In Canada, the next step for pharma serialization is planned for the end of 2023. In doing so, the country aims to improve tracking along the supply chain as well as patient safety. The North American country is thus pursuing the goal of providing all pharmaceuticals with a GS1 DataMatrix at the primary and secondary […]
Chestny ZNAK is the track andtrace system for the Russian market. Apart from pharmaceuticals, it ensures the security of the supply chain of many other goods. These goods include tobacco products, beer, medical devices, and food supplements. Counterfeit protection is expanding to fields other than pharmaceuticals, as Russia’s markets are particularly affected by counterfeiting. According […]
As of February 2023, EMVO’s AMS portal has been available to pharmaceutical companies for processing their alerts. With many functions, a clear presentation, and active user management, it makes the processing of error messages much easier. Since the EU-FMD came into force, alerts have also been a concern for pharmaceutical manufacturers. Recently, there have been […]
November 2023 marks an important date for the US pharmaceutical industry. The final phase of the DSCSA requirements revolves around interoperability and increased supply chain assurance. Verification Router Services (VRS) are one building block to meet the requirements. The DSCSA requires that all trading partners have a secure, electronic, and interoperable system in place for […]
Read More… from Understanding VRS: The 2023 DSCSA requirements
Pharmaceutical companies in need of a serialization provider are well-advised not to choose one arbitrarily. As an integral part of compliance and possibly years of collaboration, it is important to have a partner with whom you are fully satisfied. This is because, as in any industry, there are quite a few differences between providers. In […]
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In the European Union, medicinal products and medical devices are only approved for the market if manufacturers can guarantee the safety of their products. If adverse events occur after the products have been placed on the market, the vigilance procedures of the respective industries take effect. This is because patient safety continues to be a […]
Despite comprehensive preclinical and clinical studies, it is not uncommon for drug risks to be discovered only after market approval. Possible reasons are a larger patient population, multi-medication, off-label use, or medication errors. The pharmacovigilance department has the important task of identifying, assessing, better understanding and, if necessary, reporting these risks. In this way, a […]
Earlier this year, the European Medicines Verification Organization (EMVO) released its new Alert Management System (AMS) portal to improve the exchange of information between stakeholders in the event of suspected counterfeiting. In addition, the initiated investigations can be tracked and logged more easily with the help of this portal. Due to the pan-European approach of […]
Outsourcing usually evokes negative connotations. We think of jobs being lost and moved abroad because they can be filled more cheaply there. But what about industries where there is a severe shortage of skilled workers and qualified staff is hard to find? This is where Business Process Outsourcing (BPO) comes into play. Complex tasks are […]