What is EN ISO 13485:2016/AC:2020 ?

EN ISO 13485:2016/AC:2020 is a critical technical standard for pharmaceutical manufacturers, which focuses on the validation and control of sterile barrier systems used in the production of medicinal products. This article will provide an overview of EN ISO 13408-2 and discuss its significance in ensuring the safety and quality of pharmaceutical products.

EN ISO 13408-2:2019 is a technical standard that establishes guidelines for the validation and control of sterile barrier systems used in pharmaceutical manufacturing processes. These systems are critical in ensuring the integrity and sterility of medicinal products, particularly those that are terminally sterilized. By adhering to the requirements outlined in EN ISO 13408-2, pharmaceutical companies can minimize the risk of contamination, maintain product quality, and ensure the safety of patients who rely on their products.

EN ISO 15763:2019 is an essential technical standard that focuses on establishing guidelines for the management of measurement processes in industries. It aims to ensure that measurements carried out by organizations are accurate, reliable, and traceable, ultimately enhancing product quality and customer satisfaction.

Key Features and Benefits of EN ISO 13408-2:2019 and EN ISO 15763:2019

EN ISO 13408-2:2019 provides a comprehensive guide for pharmaceutical manufacturers on how to establish and maintain effective sterile barrier systems for their products. It outlines the critical aspects of sterile barrier system design, testing, and monitoring, helping manufacturers implement robust processes and systems that comply with regulatory requirements. By implementing EN ISO 13408-2:2019, pharmaceutical companies can ensure the safety and quality of their products and maintain product integrity.

EN ISO 15763:2019 is an essential standard for companies in various industries that focus on measurement management. It provides guidelines for implementing effective measurement management systems, addressing key elements such as planning, execution, analysis, documentation, and improvement of measurement processes. By following the guidelines outlined in EN ISO 15763:2019, companies can enhance product quality, improve customer satisfaction, and ensure compliance with international quality requirements.

Conclusion

In conclusion, EN ISO 13408-2:2019 and EN ISO 15763:2019 are crucial technical standards that focus on the validation and control of sterile barrier systems used in pharmaceutical manufacturing processes and measurement management, respectively. These standards provide guidelines for implementing effective sterile barrier systems and measurement management systems, ensuring the safety and quality of pharmaceutical products and enhancing product quality, customer satisfaction, and compliance with international quality requirements. Compliance with these standards is vital for pharmaceutical companies to maintain product integrity, ensure the safety and quality of their products, and ensure that their processes are in line with regulatory requirements.