What is EN ISO 13485: 2016/AC: 2018 ?

EN ISO 13485: 2016/AC: 2018 is a critical standard for pharmaceutical manufacturers, as it establishes guidelines for the validation and control of sterile barrier systems used in the production of medicinal products. These systems are essential in ensuring the integrity and sterility of medical products, particularly those that are terminally sterilized. EN ISO 13408-2: 2019 provides a comprehensive guide for pharmaceutical manufacturers to minimize the risk of contamination, maintain product quality, and ensure the safety of patients.

EN ISO 15763: 2019 is a technical standard designed to establish guidelines for the management of measurement processes in various industries. It aims to improve product quality and customer satisfaction by ensuring that measurements carried out by organizations are accurate, reliable, and traceable. EN ISO 15763: 2019 provides guidance on implementing effective measurement management systems, addressing key elements such as planning, execution, analysis, documentation, and improvement of measurement processes.

EN ISO 13408-2: 2019 and EN ISO 15763: 2019 are essential for ensuring the safety and quality of pharmaceutical products. Compliance with these standards is critical for maintaining the integrity of medical products and reducing the risk of contamination. By implementing these standards, pharmaceutical manufacturers can provide a safer and more reliable product for patients.