What is EN ISO 13485:2016/AC:2017 ?

EN ISO 13485:2016/AC:2017 is a critical technical standard that outlines the guidelines for the validation and control of sterile barrier systems used in the production of pharmaceutical 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 focuses on 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.

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. This standard is crucial for professionals seeking to comply with international quality requirements and ensure the safety and efficiency of their processes.

In conclusion, EN ISO 13408-2:2019 and EN ISO 15763:2019 are both essential technical standards that play a critical role in ensuring the safety and quality of pharmaceutical products. Compliance with these standards is vital for maintaining the integrity of the manufacturing process, minimizing the risk of contamination, and enhancing product quality.